scholarly journals Randomized, Controlled Comparison of Advanced Hemostatic Pads in Hepatic Surgical Models

ISRN Surgery ◽  
2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Kevin M. Lewis ◽  
Jeff McKee ◽  
Alexandra Schiviz ◽  
Alexander Bauer ◽  
Martin Wolfsegger ◽  
...  

Blood loss during hepatic surgery leads to poor patient outcomes. This study investigates the hemostatic efficacy of a novel sealing hemostatic pad (polyethylene glycol-coated collagen, PCC) and a fibrin sealant pad (fibrin-thrombin coated collagen, FTC) in a leporine hepatic segmentectomy and a porcine hepatic abrasion model. A segmentectomy was used to compare hemostatic success and hematoma incidence in 20 rabbits (10/group). Hepatic abrasions were used to compare hemostatic success up to 10 min after application in six pigs (42 lesions/group). In the segmentectomy model, PCC achieved 100% hemostatic success within 2 min (95% CI: 72.3% to 100%) and FTC achieved 80% hemostatic success within 3 min (49.0% to 94.3%). PCC had lower hematoma incidence at 15 min (0.0 versus 11.1%) and 24 h (20.0 versus 66.7%). In the abrasion model, PCC provided superior hemostatic success at 3 (odds ratio: 24.8, 95% CI: 8.86 to 69.2, P<0.001), 5 (66.3, 28.5 to 153.9, P<0.001), 7 (177.5, 64.4 to 489.1, P<0.001), and 10 min (777.6, 148.2 to 4078, P<0.001) leading to statistically significant less blood loss. The novel sealing hemostat provides faster and more sustained hemostasis than a fibrin sealant pad in a leporine hepatic segmentectomy and a porcine hepatic abrasion model of hepatic surgery.

2020 ◽  
Author(s):  
Fan Yong Yong ◽  
deng bo ◽  
Hong Hai Nan ◽  
Zhu Zhong

Abstract PurposeThe efficacy and safety of topical fibrin sealant (FS) compared with tranexamic acid (TXA) to reduce blood loss after total hip arthroplasty (THA) is not clear. A meta-analysis was conducted to evaluate the efficacy and safety of topical FS versus topical or intravenous TXA for treatment of primary THA.MethodWe searched electronic databases, including PubMed, Embase, and the Cochrane Library to identify studies up to March 2020. The references included in articles were also checked for additional potentially-relevant studies. The language of publication was limited to English. The endpoints included the mean difference (MD) of blood loss, hemoglobin value, and odds ratios (ORs) of transfusion requirements and thrombotic events. Our meta-analysis was performed according to the Guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. The data of the included studies were analyzed using RevMan 5.3.ResultsA total of four studies (two randomized controlled trials and two non-randomized controlled trials) met the inclusion criteria. Our meta-analysis demonstrated that TXA administration led to significantly different outcomes in terms of transfusion rate (RD = -0.12, 95% CI (-0.23, -0.00), P = 0.05, I2 = 74%) and postoperative hemoglobin levels (WMD = -0.47, 95% CI (-0.74, -021), P = 0.0005, I2 = 3%) compared with topical application of FS in patients undergoing THA. No significant difference was seen in total calculated blood loss (WMD = -86.22, 95% CI (-99.13, -73.31), P < 0.00001, I2 = 96%) or complication rate (RR = 0.98, 95% CI (-99.13, -73.31), P = 0.45, I2 = 0%) between the two groups.ConclusionsTXA administration can effectively decrease the transfusion rate and result in higher postoperative hemoglobin levels without increasing the rate of infection.


2020 ◽  
Author(s):  
Yong Yong Fan ◽  
Hai Nan Hong ◽  
Bo Deng ◽  
Zhong Zhu

Abstract Purpose: The efficacy and safety of topical fibrin sealant (FS) compared with tranexamic acid (TXA) to reduce blood loss after total hip arthroplasty (THA) is not clear. A meta-analysis was conducted to evaluate the efficacy and safety of topical FS versus topical or intravenous TXA for treatment of Method: We searched electronic databases, including PubMed, EMBASE, and the Cochrane Library to identify studies up to March 2020. The references included in articles were also checked for additional potentially-relevant studies. The language of publication was limited to English. The endpoints included the mean difference (MD) of blood loss, hemoglobin value, and odds ratios (ORs) of transfusion requirements and thrombotic events. Our meta-analysis was performed according to the Guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. The data of the included studies were analyzed using RevMan 5.3.Results: A total of four studies (two randomized controlled trials and two non-randomized controlled trials) met the inclusion criteria. Our meta-analysis demonstrated that TXA administration led to significantly different outcomes in terms of transfusion rate (RD = -0.12, 95% CI (-0.23, -0.00), P = 0.05, I2 = 74%) and postoperative hemoglobin levels (WMD = -0.47, 95% CI (-0.74, -021), P = 0.0005, I2 = 3%) compared with topical application of FS in patients undergoing THA. No significant difference was seen in total calculated blood loss (WMD = -86.22, 95% CI (-99.13, -73.31), P < 0.00001, I2 = 96%) or complication rate (RR = 0.98, 95% CI (-99.13, -73.31), P = 0.45, I2 = 0%) between the two groups.Conclusions: TXA administration can effectively decrease the transfusion rate and result in higher postoperative hemoglobin levels without increasing the rate of infection.


Author(s):  
Michael Staehler ◽  
S. Rodler ◽  
M. Schott ◽  
J. Casuscelli ◽  
C. Stief ◽  
...  

Abstract Purpose To describe the results of a polyethylene glycol-coated collagen patch, Hemopatch® on blood loss, surgical time and renal function in partial nephrectomy (PN) for renal cell carcinoma (RCC). Methods Out of a single surgeon cohort of n = 565 patients undergoing conventional open PN (CPN) between 01/2015 and 12/2017 at the University of Munich a consecutive subgroup (n = 42) was operated on using a polyethylene glycol-coated collagen-based sealant Hemopatch® (Baxter International Inc., Deerfield, IL, USA) (HPN). Results Median age was 65.2 years (range 12.7–95.2) with median follow-up of 9.43 months (0.03–49.15). Baseline renal function (CKD-EPI) was 78.56 ml/min/1.73 m2 (range 20.38–143.09) with a non-significant decline to 74.78 ml/min/1.73 m2 (range 3.75–167.74) at follow-up. In CPN 46% had low complexity, 33% moderate complexity and 20% high complexity lesions with 33% low, 40% moderate and 27% high complexity masses in HPN. Median tumor size was 4.3 cm (range 1–38 cm) in CPN with 4.8 cm (range 3.8–18.3 cm) with HPN, p = 0.293. Median blood loss and duration of surgery was significantly lower in the HPN group vs. CPN (146 ml ± 195 vs. 114 ml ± 159 ml; p = 0.021; 43 min ± 27 for HPN vs. 53 min ± 49; p = 0.035) with no difference in clamping time (12.6 min ± 8.6 for HPN vs. 12.0 min ± 9.5; p = 0.701). Conclusions Hemopatch® supported renoraphy shows promising results compared to standard renoraphy in PN. No side effects were seen. Further studies should evaluate the prevention of arterio-venous or urinary fistulas. In complex partial nephrectomies Hemopatch® supported renoraphy should be considered.


2019 ◽  
Vol 14 (1) ◽  
Author(s):  
Anil Kapoor ◽  
Emily Chu Lee Wong ◽  
Gaurav Vasisth ◽  
Yanbo Guo ◽  
Fadil Hassan ◽  
...  

Introduction: The objective of this study was to evaluate the safety and feasibility of using a polyethylene glycol (PEG)-coated collagen patch (Hemopatch®) in patients undergoing deceased donor renal transplant. The primary outcome was the amount of intraoperative estimated blood loss in those patients receiving the patch compared to without. Secondary outcomes were the subjective achievement of hemostasis, perigraft collection, and drop in hemoglobin 48 hours postoperatively. Methods: We performed a single-center, prospective, randomized trial. Patients scheduled to undergo deceased donor renal transplant surgery were randomized to receive the PEG-coated patch or standard hemostasis (i.e., electrocautery and clips). Results: A total of 30 patients were enrolled over 15 months and randomized to receive the PEG-coated patch (n=15) or standard hemostasis (n=15). The mean age was 62.5 years. As determined by the operating surgeon, hemostasis was successfully achieved in all 15 cases using the PEG-coated patch. In the PEG-coated patch group, there was a trend towards less estimated blood loss (237 cc vs. 327 cc; p=0.11) and a lower drop in hemoglobin 48 hours postoperatively (22.27 g/L vs. 29.53 g/L; p=0.09) compared to the standard hemostasis group. Perigraft collection was similar between groups (27% vs. 40%; p=0.43). Subgroup analysis on patients who received anticoagulation therapy revealed no significant difference in blood loss between groups. Conclusions: Based on our single-center experience, the PEG-coated patch (Hemopatch®) is a safe and feasible option to aid hemostasis during deceased donor renal transplant surgery. Hemostasis was successfully achieved in all cases using the PEG-coated patch.


VASA ◽  
2021 ◽  
Vol 50 (1) ◽  
pp. 2-10 ◽  
Author(s):  
Xin Li ◽  
Giuseppe D’Amico ◽  
Cristiano Quintini ◽  
Teresa Diago Uso ◽  
Sameer Gadani ◽  
...  

Summary: Intravascular ultrasound (IVUS) has been used extensively in coronary applications. Its use in venous applications has increased as endovascular therapy has increasingly become the mainstay therapy for central venous diseases. IVUS has been used for both diagnostic and therapeutic purposes in managing venous stenotic disease, venous occlusive disease, and IVC filter placement and removal. IVUS has been proven to be effective in providing detailed measurement of the venous anatomy, which aid in determining the appropriate size and the approach for venous stent placement. In IVC filter placement, IVUS can provide detailed measurement and guide IVC filter placement in emergent and critical care settings. It also has certain utility in filter removal. At any rate, to date there are only a few studies examining its impact on patient outcomes. Prospective randomized controlled trials are warranted in the future.


2021 ◽  
pp. 219256822110164
Author(s):  
Elsayed Said ◽  
Mohamed E. Abdel-Wanis ◽  
Mohamed Ameen ◽  
Ali A. Sayed ◽  
Khaled H. Mosallam ◽  
...  

Study Design: Systematic review and meta-analysis. Objectives: Arthrodesis has been a valid treatment option for spinal diseases, including spondylolisthesis and lumbar spinal stenosis. Posterolateral and posterior lumbar interbody fusion are amongst the most used fusion techniques. Previous reports comparing both methods have been contradictory. Thus, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to establish substantial evidence on which fusion method would achieve better outcomes. Methods: Major databases including PubMed, Embase, Web of Science and CENTRAL were searched to identify studies comparing outcomes of interest between posterolateral fusion (PLF) and posterior lumbar interbody fusion (PLIF). We extracted data on clinical outcome, complication rate, revision rate, fusion rate, operation time, and blood loss. We calculated the mean differences (MDs) for continuous data with 95% confidence intervals (CIs) for each outcome and the odds ratio with 95% confidence intervals (CIs) for binary outcomes. P < 0.05 was considered significant. Results: We retrieved 8 studies meeting our inclusion criteria, with a total of 616 patients (308 PLF, 308 PLIF). The results of our analysis revealed that patients who underwent PLIF had significantly higher fusion rates. No statistically significant difference was identified in terms of clinical outcomes, complication rates, revision rates, operation time or blood loss. Conclusions: This systematic review and meta-analysis provide a comparison between PLF and PLIF based on RCTs. Although PLIF had higher fusion rates, both fusion methods achieve similar clinical outcomes with equal complication rate, revision rate, operation time and blood loss at 1-year minimum follow-up.


2021 ◽  
Vol 5 (1) ◽  
pp. 2514183X2110173
Author(s):  
Johannes Kaesmacher ◽  
Giovanni Peschi ◽  
Nuran Abdullayev ◽  
Basel Maamari ◽  
Tomas Dobrocky ◽  
...  

Objective: To identify factors associated with early angiographic reperfusion improvement (EARI) following intra-arterial fibrinolytics (IAF) after failed or incomplete mechanical thrombectomy (MT). Methods: A subset of patients treated with MT and IAF rescue after incomplete reperfusion included in the INFINITY (INtra-arterial FIbriNolytics In ThrombectomY) multicenter observational registry was analyzed. Multivariable logistic regression was used to identify factors associated with EARI. Heterogeneity of the clinical effect of EARI on functional independence (defined as modified Rankin Score ≤2) was tested with interaction terms. Results: A total of 228 patients (median age: 72 years, 44.1% female) received IAF as rescue for failed or incomplete MT and had a post-fibrinolytic angiographic control run available (50.9% EARI). A cardioembolic stroke origin (adjusted odds ratio (aOR) 3.72, 95% confidence interval (CI) 1.39–10.0) and shorter groin puncture to IAF intervals (aOR 0.82, 95% CI 0.71–0.95 per 15-min delay) were associated with EARI, while pre-interventional thrombolysis showed no association (aOR 1.15, 95% CI 0.59–2.26). The clinical benefit of EARI after IAF seemed more pronounced in patients without or only minor early ischemic changes (Alberta Stroke Program Early Computed Tomography Score (ASPECTS) ≥9, aOR 4.00, 95% CI 1.37–11.61) and was absent in patients with moderate to severe ischemic changes (ASPECTS ≤8, aOR 0.94, 95% CI 0.27–3.27, p for interaction: 0.095). Conclusion: Early rescue and a cardioembolic stroke origin were associated with more frequent EARI after IAF. The clinical effect of EARI seemed reduced in patients with already established infarcts. If confirmed, these findings can help to inform patient selection and inclusion criteria for randomized-controlled trials evaluating IAF as rescue after MT.


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