scholarly journals Utilizing Autologous Multipotent Mesenchymal Stromal Cells andβ-Tricalcium Phosphate Scaffold in Human Bone Defects: A Prospective, Controlled Feasibility Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-12 ◽  
Author(s):  
Pavel Šponer ◽  
Stanislav Filip ◽  
Tomáš Kučera ◽  
Jindra Brtková ◽  
Karel Urban ◽  
...  
Keyword(s):  
Mesenchymal Stromal Cells ◽  
Stromal Cells ◽  
Tricalcium Phosphate ◽  
Bone Defects ◽  
Feasibility Trial ◽  
Harris Hip Score ◽  
Controlled Study ◽  
Control Group ◽  
Trial Group ◽  
Significant Difference

The purpose of this prospective controlled study was to compare healing quality following the implantation of ultraporousβ-tricalcium phosphate, containing either expanded autologous mesenchymal stromal cells (trial group, 9 patients) orβ-tricalcium phosphate alone (control group, 9 patients), into femoral defects during revision total hip arthroplasty. Both groups were assessed using the Harris Hip Score, radiography, and DEXA scanning at 6 weeks and 3, 6, and 12 months postoperatively. A significant difference in the bone defect healing was observed between both groups of patients (P<0.05). In the trial group, trabecular remodeling was found in all nine patients and in the control group, in 1 patient only. Whereas, over the 12-month follow-up period, no significant difference was observed between both groups of patients in terms of the resorption ofβ-tricalcium phosphate, the significant differences were documented in the presence of radiolucency and bone trabeculation through the defect (P<0.05). Using autologous mesenchymal stromal cells combined with aβ-tricalcium phosphate scaffold is a feasible, safe, and effective approach for management of bone defects with compromised microenvironment. The clinical trial was registered at the EU Clinical Trials Register before patient recruitment has begun (EudraCT number2012-005599-33).

scholarly journals The clinical efficacy of arthroscopic therapy with knee infrapatellar fat pad cell concentrates in treating knee cartilage lesion: a prospective, randomized, and controlled study

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Yiqin Zhou ◽  
Haobo Li ◽  
Dong Xiang ◽  
Jiahua Shao ◽  
Qiwei Fu ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Mesenchymal Stromal Cells ◽  
Stromal Cells ◽  
Knee Arthroscopy ◽  
Infrapatellar Fat Pad ◽  
Control Group ◽  
Knee Cartilage ◽  
Fat Pad ◽  
Group 12 ◽  
Significant Difference

Abstract Introduction To evaluate the clinical efficacy of arthroscopic therapy with infrapatellar fat pad cell concentrates in treating knee cartilage lesions, we conducted a prospective randomized single-blind clinical study of controlled method. Methods Sixty cases from Shanghai Changzheng Hospital from April 2018 to December 2019 were chosen and randomly divided into 2 groups equally. Patients in the experiment group were treated through knee arthroscopy with knee infrapatellar fat pad cell concentrates containing mesenchymal stromal cells, while patients in the control group were treated through regular knee arthroscopic therapy. VAS and WOMAC scores were assessed at pre-operation, and 6 weeks, 12 weeks, 6 months, and 12 months after intervention. MORCART scores were assessed at pre-operation and 12 months after intervention. Results Twenty-nine cases in the experiment group and 28 cases in the control group were followed up. No significant difference in VAS, WOMAC, and MOCART scores were found between the two groups before surgery (P > 0.05). The WOMAC total and WOMAC function scores of the experiment group were significantly lower than those of the control group 6 months and 12 months after surgery (P < 0.05). The VAS rest and VAS motion scores of the experiment group were found significantly lower than those of the control group 12 months after surgery (P < 0.05). The MOCART scores of the experiment group were found significantly higher compared with the control group 12 months after surgery (P < 0.05). No significant difference in WOMAC stiffness scores were found between the two groups. Conclusions The short-term results of our study are encouraging and demonstrate that knee arthroscopy with infrapatellar fat pad cell concentrates containing mesenchymal stromal cells is safe and provides assistance in reducing pain and improving function in patients with knee cartilage lesions. Trial registration ChiCTR1800015379. Registered on 27 March 2018, http://www.chictr.org.cn/showproj.aspx?proj=25901.

scholarly journals Comparative Study on the Application of Mesenchymal Stromal Cells Combined with Tricalcium Phosphate Scaffold into Femoral Bone Defects

2018 ◽  
Vol 27 (10) ◽  
pp. 1459-1468 ◽  
Author(s):  
Pavel Šponer ◽  
Tomáš Kučera ◽  
Jindra Brtková ◽  
Karel Urban ◽  
Zuzana Kočí ◽  
...  
Keyword(s):  
Stromal Cells ◽  
Tricalcium Phosphate ◽  
Bone Defects ◽  
Control Group ◽  
Graft Material ◽  
Synthetic Graft ◽  
Group A ◽  
Group B ◽  
And Control

This prospective study sought to evaluate the healing quality of implanted ultraporous β-tricalcium phosphate sown with expanded autologous mesenchymal stromal cells (MSCs) into femoral defects during revision hip arthroplasty. A total of 37 osseous defects in 37 patients were treated and evaluated concerning bone regeneration. Nineteen subjects received β-tricalcium phosphate graft material serving as a carrier of expanded autologous MSCs (the trial group A), nine subjects received β-tricalcium phosphate graft material only (the study group B) and nine subjects received cancellous allografts only (the control group C). Clinical and radiographic evaluations were scheduled at 6 weeks, 3, 6, and 12 months post-operatively, and performed at the most recent visit as well. All observed complications were recorded during follow-up to assess the use of an ultraporous β-tricalcium phosphate synthetic graft material combined with expanded MSCs in bone defect repair. The resulting data from participants with accomplished follow-up were processed and statistically evaluated with a Freeman–Halton modification of the Fischer’s exact test, a P < 0.05 value was considered to be significant. Whereas no significant difference was observed between the trial group A with β-tricalcium phosphate synthetic graft material serving as a carrier of expanded autologous MSCs and control group C with cancellous impaction allografting in terms of the bone defect healing, significant differences were documented between the study group B with β-tricalcium phosphate graft material only and control group C. Regarding adverse effects, six serious events were recorded during the clinical trial with no causal relationship to the cell product. β-tricalcium phosphate synthetic graft material serving as a carrier of expanded autologous MSCs appears safe and promotes the healing of bone defects in a jeopardized and/or impaired microenvironment. This clinical trial was registered at the EU Clinical Trials Register before patient recruitment (Registration number: EudraCT number 2012-005599-33; Date of registration: 2013-02-04).

scholarly journals The clinical efficacy of arthroscopic therapy with knee infrapatellar fat pad cell concentrates in treating knee cartilage lesion: A Prospective, Randomized and Controlled Study

2021 ◽  
Author(s):  
Yiqin Zhou ◽  
Haobo Li ◽  
Dong Xiang ◽  
Jiahua Shao ◽  
Qiwei Fu ◽  
...  
Keyword(s):  
Clinical Efficacy ◽  
Mesenchymal Stromal Cells ◽  
Stromal Cells ◽  
Knee Arthroscopy ◽  
Infrapatellar Fat Pad ◽  
Control Group ◽  
Knee Cartilage ◽  
Fat Pad ◽  
Group 12 ◽  
Significant Difference

Abstract Background: To evaluate the clinical efficacy of arthroscopic therapy with infrapatellar fat pad cell concentrates in treating knee cartilage lesions, we conducted a prospective randomized single-blind clinical study of controlled method.Methods: 60 cases from Shanghai Changzheng Hospital during April 2018 to December 2019 were chosen and randomly divided into 2 groups equally. Patients in the experiment group were treated through knee arthroscopy with knee infrapatellar fat pad cell concentrates containing mesenchymal stromal cells, while patients in the control group were treated through regular knee arthroscopic therapy. VAS and WOMAC scores were assessed at pre-operation, and 6-weeks, 12-weeks, 6-months, and 12-months after intervention. MORCART scores were assessed at pre-operation and 12-months after intervention.Results: 29 cases in the experiment group and 28 cases in the control group were followed up. No significant difference in VAS, WOMAC, and MOCART scores were found between the two groups before surgery (P>0.05). The WOMAC-Total and WOMAC-Function scores of experiment group were significantly lower than those of control group 6 months, 12 months after surgery (P<0.05). The VAS-Rest and VAS-Motion scores of experiment group were found significantly lower than those of control group 12 months after surgery (P<0.05). The MOCART scores of experiment group were found significant higher compared with control group 12 months after surgery (P<0.05). No significant difference in WOMAC-Stiffness scores were found between the two groups. Conclusions: The short-term results of our study are encouraging and demonstrate that knee arthroscopy with infrapatellar fat pad cell concentrates containing mesenchymal stromal cells is safe, and provides assistance in reducing pain and improving function in patients with knee cartilage lesions.

An Intact Ligamentum Teres Predicts a Superior Prognosis in Patients With Borderline Dysplasia: A Matched-Pair Controlled Study With Minimum 5-Year Outcomes After Hip Arthroscopic Surgery

2020 ◽  
Vol 48 (3) ◽  
pp. 673-681 ◽  
Author(s):  
David R. Maldonado ◽  
Sarah L. Chen ◽  
Rafael Walker-Santiago ◽  
Jacob Shapira ◽  
Philip J. Rosinsky ◽  
...  
Keyword(s):  
Short Form ◽  
Arthroscopic Surgery ◽  
Ligamentum Teres ◽  
Matched Pair ◽  
Harris Hip Score ◽  
Controlled Study ◽  
Control Group ◽  
Significant Difference ◽  
Patient Reported ◽  
The Mean

Background: Hip arthroscopic surgery in patients with borderline dysplasia continues to be controversial. In addition, it has been suggested that ligamentum teres (LT) tears may lead to inferior short-term patient-reported outcomes (PROs) when compared with a match-controlled group. Purposes: (1) To report minimum 5-year PROs in patients with borderline dysplasia and LT tears who underwent hip arthroscopic surgery and (2) to compare these PROs to those of a matched-pair control group of patients with borderline dysplastic hips without LT tears. Study Design: Cohort study; Level of evidence, 3. Methods: Data were prospectively collected for patients who underwent hip arthroscopic surgery between September 2008 and August 2013. Patients were included if they had a preoperative diagnosis of borderline dysplasia (lateral center-edge angle [LCEA], 18°-25°) and had preoperative and minimum 5-year postoperative modified Harris Hip Score (mHHS), Nonarthritic Hip Score (NAHS), and visual analog scale (VAS) for pain scores. Exclusion criteria were osteoarthritis of Tönnis grade >1, previous hip conditions, any previous ipsilateral hip surgery, or workers’ compensation status. There were 2 borderline dysplastic groups created. An LT tear group was matched 1:1 to a control group (no LT tear) with similar age, sex, body mass index (BMI), and laterality via propensity score matching. Significance was set at P < .05. Results: A total of 24 patients with an LT tear (24 hips) were matched to 24 patients without an LT tear (24 hips). There was no significant difference in age, sex, BMI, or laterality between groups. The mean age was 36.2 ± 17.2 and 34.9 ± 15.9 years for the control and LT tear groups, respectively ( P = .783). There were 17 (70.8%) and 16 (66.7%) female patients in the control and LT tear groups, respectively, and the mean preoperative LCEA was 23.3° and 22.2° in the control and LT tear groups, respectively. No differences were observed between groups in baseline PROs, intraoperative findings, or surgical procedures. LT debridement was performed in 17 (70.8%) patients in the LT tear group compared with 0 (0.0%) in the control group. Also, 5-year postoperative PROs were comparable in both groups, with the control group exhibiting superior Veterans RAND 12-Item Health Survey (VR-12) mental ( P = .041) and Short Form–12 (SF-12) mental ( P = .042) scores. Finally, hips with an intact LT were significantly more likely ( P = .022) to achieve the patient acceptable symptomatic state (PASS) for the mHHS (100.0% and 75.0%, respectively). No significant differences were present between the groups for the minimal clinically important difference (MCID) of the mHHS ( P = .140), MCID of the Hip Outcome Score–Sport-Specific Subscale (HOS-SSS) ( P = .550), or PASS of the HOS-SSS ( P = .390). Conclusion: After hip arthroscopic surgery, patients with borderline dysplasia and LT tears demonstrated favorable PROs at a minimum 5-year follow-up. Outcomes were similar to a matched-pair control group without LT tears, with the group with intact LTs showing higher VR-12 mental and SF-12 mental scores. Furthermore, patients with borderline dysplasia and intact LTs were significantly more likely to achieve the PASS for the mHHS.

scholarly journals The Survey of Effectiveness of Group Counseling with Cognitive – Behavioural Method in Reducing Mother’s Stress of Child with Mental Retardation under 6 Years Old Under Cover of Khorramabad Province Welfare Organization (2012)

2013 ◽  
Vol 4 (2) ◽  
pp. 391
Author(s):  
Azarinvand, Abrahim ◽  
Gorjee, Yosef ◽  
Sadrepooshan, Najmeh ◽  
Esmaili, Ghasem
Keyword(s):  
Mental Retardation ◽  
Group Counseling ◽  
Repeated Measurements ◽  
Cognitive Behavioral ◽  
Control Group ◽  
Trial Group ◽  
Significant Difference ◽  
Group 15 ◽  
Behavioral Method ◽  
And Control

<p>The aim of this study was to investigate the effectiveness of group counseling with cognitive – behavioral method in reducing mother’s stress of child with mental retardation less than 6 years old covered of Khorramabad province welfare organization (2012). The statistical society of this study consisted of 52 mothers of child with mental retardation who their children had file in the welfare office. 30 persons were selected by simple random sampling and were divided into two groups including trial group (15 persons) and control group (15 persons).</p><p>The method of study was quasi – experimental way with control group and random trial and data gathering tool such as Friedrich, Greenberg and Crink resources and stress questionnaire. To perform the study; the first step was pretest trial and control group and then 10 group counseling sessions with cognitive- behavioral method had hold among trial group. The control group’s mothers did not receive any counseling. Then, it established post – testing of both group again and another test provided to following – up step for two weeks after test.</p><p>The result of variance analysis with repeated measurements showed that, there is significant difference in percentage1 level between control and trial groups post – test and follow – up scores, so, the first hypothesis of this study had approved upon group counseling efficacy with cognitive – behavioral method in reducing mother’s stress of child with mental retardation. In addition, these results showed that group counseling with cognitive – behavioral method has been established significant reduction in percentage 1 level physical and emotional symptoms of trial groups’ mothers, but it did not find the significant difference in the cognitive symptoms.</p>

Comparison of the Therapeutic Potential of Rat and Human Mesenchymal Stromal Cells and Their Conditioned Media in Local Radiation Lesions

2021 ◽  
Vol 66 (4) ◽  
pp. 5-12
Author(s):  
A. Rastorgueva ◽  
T. Astrelina ◽  
V. Brunchukov ◽  
D. Usupzhanova ◽  
I. Kobzeva ◽  
...  
Keyword(s):  
Conditioned Medium ◽  
Mesenchymal Stromal Cells ◽  
Stromal Cells ◽  
White Male ◽  
Conditioned Media ◽  
Control Group ◽  
Skin Ulcers ◽  
Calculated Dose ◽  
Local Radiation ◽  
Gingival Mucosa

Background: To compare the results of the use of mesenchymal stromal cells (MSCs) of human gingival mucosa and MSCs of rat gingival mucosa, their conditioned media, and to evaluate their effect on tissue regeneration in local radiation injury (LRI). Material and methods: The study included 120 white male Wistar rats weighing 210 ± 30 g at the age of 8–12 weeks, randomized into 6 groups (20 animals each): control (C), animals did not receive therapy; control with the introduction of culture medium concentrate (CM) three times for 1, 14, 21 days; administration of human gingival mucosa MSCs (HM) at a dose of 2 million per 1 kg three times for 1, 14, 21 days; administration of human gingival mucosa MSCS conditioned medium concentrate (HMCM) at a calculated dose of 2 million cells per 1 kg three times for 1, 14, 21 days; administration of rat gingival mucosal MSCs (RM) at a dose of 2 million cells per 1 kg three times for 1, 14, 21 days; administration of rat gingival mucosal MSCS (RMCM) conditioned medium concentrate at a calculated dose of 2 million cells per 1 kg three times for 1, 14, 21 days. Each laboratory animal was observed 17 times: on 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, 112 day after the burn simulation. Histological (hematoxylin-eosin staining) and immunohistochemical (CD31, CD68, VEGF, PGP 9.5, MMP2,9, Collag 1, TIMP 2) studies were performed. LRI was modeled on an X-ray machine at a dose of 110 Gy. MSCs were cultured according to the standard method up to 3–5 passages, the conditioned medium was taken and concentrated 10 times. The immunophenotype of MSCs (CD34, CD45, CD90, CD105, CD73, HLA-DR) and viability (7‑ADD) were determined by flow cytofluorimetry. Results: In a comparative analysis with the control group (C), starting from the 42nd day of the study, a tendency to reduce the area of skin ulcers in animals in all groups was observed, despite the fact that not all days had statistically significant differences. On day 112th, complete healing of skin ulcers in the CM group was observed in 40 % of animals in the HM group – in 60 %, in the HMCM group – in 20 % of animals, in the RMCM group–20 %, and in the C and RM groups there were no animals with a prolonged wound defect. Positive expression of the VEGF marker was observed in groups C and CM on the 28th day and in experimental groups (HM, HMCM, RM, RMCM) on the 112th day. A statistically significant increase in the CD68 marker was observed in groups C, RM, and RMCM, while the remaining groups showed a decrease in the number of macrophages.

Comparative Analysis of Biological and Functional Properties of Bone Marrow Mesenchymal Stromal Cells Expanded in Media with Different Platelet Lysate Content

2018 ◽  
Vol 205 (4) ◽  
pp. 226-239 ◽  
Author(s):  
Marijana Skific ◽  
Mirna Golemovic ◽  
Kristina Crkvenac-Gornik ◽  
Radovan Vrhovac ◽  
Branka Golubic Cepulic
Keyword(s):  
Bone Marrow ◽  
Mesenchymal Stromal Cells ◽  
Stromal Cells ◽  
Immunological Tolerance ◽  
Biological Properties ◽  
Platelet Lysate ◽  
Population Doubling ◽  
Population Doubling Time ◽  
Significant Difference

Due to their ability to induce immunological tolerance in the recipient, mesenchymal stromal cells (MSCs) have been utilized in the treatment of various hematological and immune- and inflammation-mediated diseases. The clinical application of MSCs implies prior in vitro expansion that usually includes the use of fetal bovine serum (FBS). The present study evaluated the effect of different platelet lysate (PL) media content on the biological properties of MSCs. MSCs were isolated from the bone marrow of 13 healthy individuals and subsequently expanded in three different culture conditions (10% PL, 5% PL, 10% FBS) during 4 passages. The cells cultured in different conditions had comparable immunophenotype, clonogenic potential, and differentiation capacity. However, MSC growth was significantly enhanced in the presence of PL. Cultures supplemented with 10% PL had a higher number of cumulative population doublings in all passages when compared to the 5% PL condition (p < 0.03). Such a difference was also observed when 10% PL and 10% FBS conditions were compared (p < 0.005). A statistically significant difference in population doubling time was determined only between the 10% PL and 10% FBS conditions (p < 0.005). Furthermore, MSCs cultured in 10% PL were able to cause a 66.9% reduction of mitogen-induced lymphocyte proliferation. Three chromosome aberrations were detected in PL conditions. Since two changes occurred in the same do nor, it is possible they were donor dependent rather than caused by the culture condition. These findings demonstrate that a 10% PL condition enables a higher yield of MSCs within a shorter time without altering MSC properties, and should be favored over the 5% PL condition.

Evaluation of red cell distribution width (RDW) as a septic marker in comparison with clinical scores and C-reactive protein

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Ali Ahmed Naga ◽  
Mohammed Ismaeil Abdel Fattah ◽  
Walid Hamed Nofal ◽  
Mohammed Abd-elsalam AlMenshawe
Keyword(s):  
Septic Shock ◽  
Severe Sepsis ◽  
Controlled Study ◽  
Control Group ◽  
Study Group ◽  
Distribution Width ◽  
Clinical Scores ◽  
Group I ◽  
Significant Difference ◽  
Sepsis And Septic Shock

Abstract Background Challenges of diagnosing and treating sepsis only seem more difficult as incidence increases, patients become older and sicker, and pathogenic organisms evolve. New understanding of inflammatory mediators and pathways, immunity, and genetic variability in this disease state suggests that the current definitions of SIRS, sepsis, severe sepsis, and septic shock are oversimplified. Objective The aim of our study is to evaluate the level of RDW, CRP and clinical scores "SOFA and APACHI" as markers in patients with sepsis and their levels on the outcome and resolution of sepsis in ICU. Methodology We conducted a prospective observational controlled study on 90 adult persons of both sex, 45 of them are adult patients and served as the study group (Group I), and the other 45 are healthy adult volunteers and served as the control group (Group II). The study group represented patients admitted to the ICU of Intensive Care Unit at Damanhour Medical National Institute who fulfilled the diagnostic criteria for sepsis, severe sepsis and septic shock on arrival to ICU according to the SCCM/ ESICM/ ACCP/ ATS/SIS International Sepsis Definitions Conference. Results. In the present study we found that CRP measured on admission was not a predictor of mortality, while that measured at day 5 and day 10 predicted mortality, where there was no statistically significant difference in CRP levels between survivors and non-survivors at the day of admission while there were statistically significant differences between survivors and non survivors according to CRP levels at day 5 (p = 0.001*) and at day 10 (p = 0.001*). It was found also that there were statistically significant differences between survivors and non-survivors according to RDW at day 1(p = 0.011*) and at day 5(p = 0.009*), at day 10 was found there was no statistically significant difference between survivors and non-survivors (p = 0.338). Conclusion RDW is a new promising cheap and readily available biomarker that can be able to diagnose patients with sepsis with accuracy comparable to CRP. Also, RDW at admission is able to predict mortality.

Comparison of Biocompatibility of Experimental Tricalcium Phosphate Cement versus Biodentin and Mineral Trioxide Aggregate used for Furcation Perforation Repair (in vivo study)

2021 ◽  
Vol 15 (1) ◽  
pp. 532-538
Author(s):  
Mostafa M. El-Bialy ◽  
Magdy M. Ali ◽  
Engy M. Kataia ◽  
Reham S. El Nemr ◽  
Reham Hassan
Keyword(s):  
Tricalcium Phosphate ◽  
Mineral Trioxide Aggregate ◽  
Positive Control ◽  
Control Group ◽  
Tooth Survival ◽  
Significant Difference ◽  
Operative Evaluation ◽  
Root Canal System ◽  
Bone Deposition

Background: The interaction between the root canal system and the oral cavity caused by iatrogenic perforations significantly affects the treatment outcome and tooth survival. Objectives: This study was directed to compare the biocompatibility of an experimental tricalcium phosphate cement versus biodentine and mineral Trioxide aggregate used for furcation perforation repair in dogs. Methods: Perforations were done in 60 teeth (premolars and molars) of six adult dogs. Animals were divided randomly into 3 equal groups of 2 animals each according to the post-operative evaluation period of 1 week, 1 month, and 3-months. Each group was further subdivided into 4 subgroups according to either being repaired with the experimental tricalcium phosphate cement (n=6), or Biodentine (n=6), Mineral Trioxide Aggregate (MTA) (n=6), and positive control(n=2). After evaluation periods, tissue blocks were harvested and histologically examined. Results: No statistically significant difference was found regarding bone deposition scores and inflammatory reaction in the three groups after 1 week, 1 month, or 3 months. All three groups showed a statistically significant difference between all three time periods. Regardless of the repair material used, inflammation scores at 1-week showed the highest scores, decreasing over time except for the control group. Conclusion: The experimental material could be considered as a successful treatment option for repairing furcation perforation.

A Prospective Clinical Evaluation of the Effects of Intraoperative Systemic Anticoagulation in Patients Undergoing Arteriovenous Fistula Surgery

2010 ◽  
Vol 76 (10) ◽  
pp. 1112-1114 ◽  
Author(s):  
Bonnie R. Wang ◽  
Vincent L. Rowe ◽  
Sung Wan Ham ◽  
Sukgu Han ◽  
Kaushal Patel ◽  
...  
Keyword(s):  
Arteriovenous Fistula ◽  
Postoperative Bleeding ◽  
Bleeding Complications ◽  
Controlled Study ◽  
Control Group ◽  
Heparin Group ◽  
Av Fistula ◽  
Fistula Surgery ◽  
Significant Difference ◽  
The Difference

No standard presently exists for the use of systemic heparin during angioaccess surgery to decrease the incidence of postoperative thrombotic complications. Our objective was to study the effects of intraoperatively administered heparin on 30-day patency and postoperative bleeding complications in patients undergoing autogenous arteriovenous (AV) fistula surgery. A prospective, double-blinded, randomized controlled study was performed on 48 patients undergoing AV fistula creation from April 2007 through November 2009. Of the 48 patients, 22 were randomized to the control group and received no heparin. Twenty-six were randomized to receive heparin (75 units/kg intravenously) before clamping of the artery. There was no significant difference in 30-day patency between the heparin and control groups (92% vs 86%, P = 0.65), respectively. Three patients (12%) developed hematomas in the heparin group compared with one (5%) in the control group; however the difference was not statistically significant ( P = 0.61). The results suggest that intraoperative administration of heparin has no statistically significant effect on 30-day patency rates or postoperative bleeding complications. Larger trials with longer term follow-up and assessment of maturation rates are needed to determine the effect of intraoperative anticoagulation on these outcomes of arteriovenous fistula surgery.

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