Abstract 17201: TEG R-time as a Comparable Method to aPTT and Heparin Levels in Pediatric Patients on Heparin Therapy

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Mamadou Diallo ◽  
Fatoumata Diallo ◽  
Andrew Torres ◽  
Sitaram Emani ◽  
Sirisha Emani
Keyword(s):  
Diagnostic Method ◽  
Pediatric Patients ◽  
Blood Product ◽  
Heparin Therapy ◽  
Activated Partial Thromboplastin Time ◽  
Product Management ◽  
Electronic Patient Records ◽  
Bleeding Events ◽  
Comparable Method ◽  
Post Cardiac Surgery

Introduction: Hemorrhage post cardiac surgery continues to be a common morbidity despite the advancement in technology in coagulation diagnostics. Although, activated partial thromboplastin time (aPTT) and FXa function (heparin levels) are commonly used methods, there is often discrepancy in results between the methods. Hypothesis: In this study, we analyzed the use of Thromboelastography (TEG) reaction-time (R-time) as an additional diagnostic method for comparison to help guide blood product management. Methods: In a retrospective study of pediatric patients (N=292) who were given heparin, TEG R-time results along with aPTT and heparin levels were collected from the electronic patient records after the approval from our institution review board. Comparisons were made between the three methods using Pearson r correlations. Correlations between the three methods and bleeding events was also analyzed. Results: There were positive moderate correlations between R-time ≥15 min vs. aPTT ≥50s ( r =0.51), R-time ≥15min, vs. heparin levels ≥0.1 IU/ml ( r =0.54); and aPTT ≥50s vs. heparin levels ≥0.1 IU/ml ( r =0.55). When R-time was ≥15min, 74% of the patients had aPTT ≥50s ( p <0.001) and 81% of the patients had heparin levels ≥0.1 IU/ml ( p <0.001). When aPTT was ≥50s, 78% of the patients had heparin levels ≥0.1 IU/ml ( p <0.001). However, no correlation was found between bleeding events vs. R-time ≥15min, aPTT ≥50s and heparin levels ≥0.1 IU/ml. Conclusions: Correlation between TEG R-time versus aPTT or heparin levels was comparable to the correlation between aPTT versus heparin levels. In conclusion, TEG R-time could be used as an additional diagnostic method to help guide blood product management.

Off-Label Antithrombin Use In Pediatrics: Evaluation Of Safety, Efficacy and Usage Patterns

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1137-1137 ◽  
Author(s):  
Rosa Diaz ◽  
Brady S Moffet ◽  
Donald Mahoney ◽  
Donald L Yee
Keyword(s):  
Pediatric Patients ◽  
Heparin Therapy ◽  
Activity Level ◽  
Ventricular Assist Devices ◽  
Bleeding Complications ◽  
Off Label Use ◽  
Bleeding Events ◽  
Off Label ◽  
Heparin Resistance ◽  
Label Use

Abstract Background Antithrombin (AT) is a naturally occurring anticoagulant, and occupies a critical role in regulating thrombin generation. AT concentrate (ATC) is indicated for patients with hereditary AT deficiency but off-label use for acquired heparin resistance in patients receiving anticoagulation for thrombotic disease is not uncommon. Use of ATC in children in this and other settings such as extracorporeal membrane oxygenation (ECMO) and ventricular assist devices (VAD) appears to be expanding. However, no guidelines exist with respect to proper indications and monitoring, and scant safety and efficacy data is available. The objective of this study was to review our substantial institutional experience with off-label pediatric use of ATC regarding indications for use, dosing practice, dosing effect, adverse events, and patient outcomes. Methods An institutional review board (IRB)-approved retrospective chart review is being performed on all pediatric patients who received human-plasma derived ATC at Texas Children’s Hospital from 2001 to 2013. Data collection includes demographic, clinical and laboratory data. We are currently reporting on the first 100 consecutive patients examined using descriptive statistics and ANOVA for group comparisons. Results One hundred patients with median age 5 months (range 0 to 216 months) received 536 doses of ATC (median 4 doses per patient, range 1 to 29) between February 2012 and May 2013. Clinical scenarios for ATC use included heparin (unfractionated (UFH) or low molecular weight (LMWH)) therapy for thrombosis in 47%, ECMO in 38%, VAD in 5% and other settings in 10% of the 100 consecutive patients analyzed. Neither dosing nor dose response (measured as AT activity level post- versus pre-ATC dose) differed significantly between these patient groups. For the group of patients who received AT for thrombosis and heparin therapy, only 57% had subtherapeutic levels (anti-Xa activity <0.3 units/mL for UFH or <0.5 units/mL for LMWH) at the time of ATC initiation. Of these, only 22% achieved therapeutic levels within 12 hours after the first ATC dose. Among all the groups, 33% of children had bleeding events within 72 hours after ATC administration, most commonly reported as oozing from line sites (n=15). There was no association between AT activity levels measured after ATC administration and bleeding events. The 2 patients that developed intracranial hemorrhage were on ECMO. There were no allergic reactions. End of hospitalization mortality was 28%. Conclusion In this high-risk cohort of pediatric patients, off-label ATC was most commonly given in the setting of heparin therapy for thrombosis and low AT levels, but often without apparent evidence for inadequate heparinization as measured by low anti-Xa activity. Although ATC administration led to a significant rise in AT activity for most patients, interindividual response to ATC varied greatly, with some patients demonstrating little to no response. Furthermore, among patients who exhibited clear signs of heparin resistance, the first administration of ATC potentiated an adequate heparin effect in only a small minority. Finally, ATC administration was associated with high rate of minor bleeding complications and rare major bleeding events. These findings raise significant questions about the safety, efficacy and appropriate use of ATC in pediatrics and highlight the need for its further prospective study. Disclosures: Off Label Use: Antithrombin concentrate.

Monitoring Heparin Therapy: Relationships between the Activated Partial Thromboplastin Time and Heparin Assays Based on Ex-Vivo Heparin Samples

1990 ◽  
Vol 63 (01) ◽  
pp. 016-023 ◽  
Author(s):  
A M H P van den Bessekaar ◽  
J Meeuwisse-Braun ◽  
R M Bertina
Keyword(s):  
Partial Thromboplastin Time ◽  
Plasma Sample ◽  
Ex Vivo ◽  
Correlation Coefficients ◽  
Heparin Therapy ◽  
Thromboembolic Disease ◽  
Activated Partial Thromboplastin Time ◽  
Venous Thromboembolic Disease ◽  
Venous Thromboembolic

SummaryFive different APTT reagents, two amidolytic anti-ITa assays, one amidoiytic anti-Xa assay, and one coagulometric anti-Xa/ anti-IIa assay were used to assess the effect of heparin in patients treated for venous thromboembolic disease. Good correlations were observed between lug-transformed APYE> determined with the various reagents (correlation coefficients: 0.92-0.96).Nevertheless there were important differences in the slopes of the lines of relationship between the APTT reagents.Good correlations were observed between the anti-Xa and anti-IIa assay results (correlation coefficients: 0.92-0.97). However, the amidolytic anti-Xa activity was significantly higher (p <0.001) than the two amidolytic anti-IIa activities. Less good correlations were observed between the log-transformed APTTs and the anti-Xa or anti-IIa activities (correlation coefficients: 0.64-0.78). The correlations were improved by transforming the APTT into APTT-ratio, i.e. the ratio of the patient’s APTT to the same patient’s APTT after removal of heparin from the plasma sample by means of ECTEOLA-cellulose treatment. The correlation coefficients of log (AFTT-ratio) with anti-Xa or anti-IIa ranged from 0.76 to 0.87.For both APTT and amidolytic heparin assay, the response to in vitro heparin was different from the response to ex vivo heparin.Therefore, equivalent therapeutic ranges should be assessed by using ex vivo samples rather than in vitro heparin. Because of the response differences between the APTT reagents, it is not adequate to define a therapeutic range for heparin therapy without specification of the reagent.

Monitoring Anticoagulant Therapy by Activated Partial Thromboplastin Time: Hirudin Assessment

1994 ◽  
Vol 72 (05) ◽  
pp. 685-692 ◽  
Author(s):  
Michael T Nurmohamed ◽  
René J Berckmans ◽  
Willy M Morriën-Salomons ◽  
Fenny Berends ◽  
Daan W Hommes ◽  
...  
Keyword(s):  
Whole Blood ◽  
Partial Thromboplastin Time ◽  
Ex Vivo ◽  
Fold Increase ◽  
Heparin Therapy ◽  
Activated Partial Thromboplastin Time ◽  
Recombinant Hirudin ◽  
Interindividual Differences ◽  
The Relationship

SummaryBackground. Recombinant hirudin (RH) is a new anticoagulant for prophylaxis and treatment of venous and arterial thrombosis. To which extent the activated partial thromboplastin time (APTT) is suitable for monitoring of RH has not been properly evaluated. Recently, a capillary whole blood device was developed for bed-side monitoring of the APTT and it was demonstrated that this device was suitable to monitor heparin therapy. However, monitoring of RH was not evaluated.Study Objectives. To evaluate in vitro and ex vivo the responsiveness and reproducibility for hirudin monitoring of the whole blood monitor and of plasma APTT assays, which were performed with several reagents and two conventional coagulometers.Results. Large interindividual differences in hirudin responsiveness were noted in both the in vitro and the ex vivo experiments. The relationship between the APTT, expressed as clotting time or ratio of initial and prolonged APTT, and the hirudin concentration was nonlinear. A 1.5-fold increase of the clotting times was obtained at 150-200 ng/ml plasma. However, only a 2-fold increase was obtained at hirudin levels varying from 300 ng to more than 750 ng RH/ml plasma regardless of the assays. The relationship linearized upon logarithmic conversion of the ratio and the hirudin concentration. Disregarding the interindividual differences, and presuming full linearity of the relationship, all combinations were equally responsive to hirudin.Conclusions. All assays were equally responsive to hirudin. Levels up to 300 ng/ml plasma can be reliably estimated with each assay. The manual device may be preferable in situations where rapid availability of test results is necessary.

scholarly journals Discordance in activated partial thromboplastin time and anti-factor Xa levels in COVID-19 patients on heparin therapy

2021 ◽  
Vol 198 ◽  
pp. 79-82
Author(s):  
Matthew Lawlor ◽  
Aakriti Gupta ◽  
Lauren S. Ranard ◽  
Mahesh V. Madhavan ◽  
Jianhua Li ◽  
...  
Keyword(s):  
Partial Thromboplastin Time ◽  
Factor Xa ◽  
Heparin Therapy ◽  
Activated Partial Thromboplastin Time

HLA Antibodies and Their Association with Blood Product Exposures in Pediatric Patients Undergoing Cardiac Transplantation

2021 ◽  
Author(s):  
Susana Cruz‐Beltran ◽  
Andrea Lane ◽  
Shivani Seth ◽  
Kati Miller ◽  
Reneé H. Moore ◽  
...  
Keyword(s):  
Cardiac Transplantation ◽  
Pediatric Patients ◽  
Blood Product ◽  
Hla Antibodies

Acquired Circulating Anticoagulants in Children With Acquired Immunodeficiency Syndrome

PEDIATRICS ◽  
1988 ◽  
Vol 82 (5) ◽  
pp. 763-765
Author(s):  
Edward R. Burns ◽  
Ben-Zion Krieger ◽  
Larry Bernstein ◽  
Arye Rubinstein
Keyword(s):  
Acquired Immunodeficiency Syndrome ◽  
Pediatric Patients ◽  
Opportunistic Infections ◽  
Laboratory Diagnosis ◽  
Activated Partial Thromboplastin Time ◽  
Test Results ◽  
Coagulation Test ◽  
Intrinsic Pathway ◽  
Acquired Immunodeficiency ◽  
Immunodeficiency Syndrome

The mechanism underlying the prolonged activated partial thromboplastin time (APTT) seen in some pediatric patients with acquired immunodeficiency syndrome (AIDS) and opportunistic infections was studied. A circulating inhibitor of coagulation was demonstrated in three patients. The inhibitor appears to be an immunoglobulin that interferes with some of the phospolipid-dependent coagulation reactions of the intrinsic pathway. This "AIDS anticoagulant" does not predispose the patient to clinical bleeding despite its ability to cause a marked prolongation of the APTT. As such, careful laboratory diagnosis of the cause of abnormal coagulation test results is necessary for children with AIDS.

scholarly journals Efficacy and Safety of Human Fibrinogen Concentrate for the Treatment of Patients with Congenital Fibrinogen Deficiency: Combined Results of the FORMA-02 and FORMA-04 Clinical Trials

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 11-12
Author(s):  
Claudia Djambas Khayat ◽  
Irina Kruzhkova ◽  
Cristina Solomon ◽  
Bruce A. Schwartz ◽  
Flora Peyvandi
Keyword(s):  
Pediatric Patients ◽  
Efficacy And Safety ◽  
Fibrinogen Concentrate ◽  
Surgical Prophylaxis ◽  
Bleeding Events ◽  
Phase 3 ◽  
Human Fibrinogen ◽  
Patients Âgés ◽  
Bleeding Episodes ◽  
Hemostatic Efficacy

Introduction: Congenital fibrinogen deficiency (CFD) is a rare disorder which results from a complete lack (afibrinogenemia) or low levels (hypofibrinogenemia) of functional fibrinogen. Treatment with human fibrinogen concentrate (HFC) can treat bleeding episodes and prevent blood loss in surgical treatment in patients with CFD. Herein we report combined data from two clinical studies on the efficacy and safety of HFC for the treatment of bleeding episodes (BEs) and surgical prophylaxis in adult, adolescent and pediatric patients. Methods: Both FORMA-02 and FORMA-04 were multinational, multicenter, prospective, open-label, uncontrolled Phase 3 studies for the use of HFC in adult and pediatric patients with CFD. They reported the hemostatic efficacy and safety of human fibrinogen concentrate (HFC: Fibryga® Octapharma) for on-demand treatment of BEs and surgical prophylaxis using objective criteria. Efficacy was assessed by the trial investigators and adjudicated by an independent data monitoring and end-point adjudication committee (IDMEAC). All adverse events (AEs) and serious AEs were recorded. Results: The two studies included a total of 39 patients who received HFC. The median (range) age across both studies was 17 (1-54) years, with 14 pediatric (aged 0-11), 6 adolescent (aged 12-18) and 19 adult patients (aged &gt;18). Treatment of Bleeding Events 32 patients received HFC for the treatment of 99 bleeding events (BEs), 97 minor and 4 major. Of these, 72 were spontaneous, and 27 were due to trauma. 10 BEs occurred in pediatric patients (8 minor, 2 major), and 89 in adult/adolescents (87 minor, 2 major). The mean (±SD) total dose per BE was 65.51 mg/kg (±26.47) for adult/adolescent patients (ages 12-54) and 93.78 (±64.60) for pediatric patients (ages 0-11). Investigator-assessed and IDMEAC rated hemostatic efficacy are shown in Table 1. Overall hemostatic efficacy was rated as success (rating of excellent or good) for 99.0% of BEs by the IDMEAC. Treatment efficacy results were comparable when analyzed by age subgroup of adult (≥18 years), adolescent (&gt;12-&lt;18 years) and in two groups of pediatric patients (&lt;6 years and 6-12 years). Surgical prophylaxis A total of 12 patients received HFC across 15 surgeries (13 minor and 2 major), 3 in pediatric patients (major: splenectomy; minor: circumcision and pulpectomy), and 12 in adults/adolescents (major: eye enucleation with socket reconstruction; minor: knee radioisotope synovectomy [n=2], dental extraction [n=3], circumcision [n=2], excision of circumcision scar bud, root canal operation, skin biopsy, and debridement of superficial necrosis). Mean (±SD) loading dose administered prior to surgery was 77.39 (±20.22) in adult/adolescent patients and 78.50 mg/kg (±27.96) for pediatric patients. Seven surgeries required multiple infusions, with the two major surgeries requiring 5 and 7 maintenance infusions, and the five minor surgeries requiring median (range) 3 (1-4) maintenance infusions. Intra- and post-operative hemostatic efficacy for all surgeries is shown in Table 1. Overall hemostatic efficacy of all the procedures was rated 100% successful by both the investigator and IDMEAC assessment. Safety A total of 101 AEs occurred in 23 patients (59.0%), including 16 serious AEs in 6 patients. Of these, 5 AEs in 4 patients were considered to be possibly related to treatment. These included a mild skin reaction (itchiness and redness), ischemia due to digital microthrombi, peripheral phlebitis of the upper limbs, and a portal vein thrombosis following splenectomy. No allergic/hypersensitivity reactions or deaths were observed during either of the studies. Conclusions: HFC treatment was shown to be efficacious for on-demand treatment of BEs and perioperative prophylaxis in this rare CFD population, across two Phase 3 clinical trials. Efficacy was comparable for adult, adolescent and pediatric patients. A favorable safety profile was seen for the treatment of patients with congenital afibrinogenemia with HFC. Disclosures Djambas Khayat: Octapharma: Research Funding. Kruzhkova:Octapharma: Current Employment. Solomon:Octapharma: Current Employment. Schwartz:Octapharma: Current Employment. Peyvandi:Octapharma: Research Funding. OffLabel Disclosure: On label use: Fibryga for treatment of bleeding episodes Off label use: Use of Fibryga as surgical prophylaxis in the US

Clinical safety and cost of heparin titration using bedside activated clotting time

1993 ◽  
Vol 2 (1) ◽  
pp. 81-87 ◽  
Author(s):  
T Thomason ◽  
B Riegel ◽  
D Jessen ◽  
Smith SCJr ◽  
I Gocka ◽  
...  
Keyword(s):  
Partial Thromboplastin Time ◽  
Percutaneous Transluminal Coronary Angioplasty ◽  
Heparin Therapy ◽  
Activated Partial Thromboplastin Time ◽  
Clotting Time ◽  
Clinical Safety ◽  
Activated Clotting Time ◽  
Intravenous Heparin ◽  
Transluminal Coronary Angioplasty ◽  
Percutaneous Transluminal

OBJECTIVE: To evaluate the clinical safety of heparin titration and the procedural cost of anticoagulation measurement using bedside low-range activated clotting time. DESIGN: Quasi-experimental study using data gathered through retrospective record review. SETTING: Coronary care, medical intensive care and telemetry units of a community hospital. SUBJECTS: Sample of 102 patients undergoing elective percutaneous transluminal coronary angioplasty. INTERVENTION: Intravenous heparin therapy was titrated using low-range activated clotting time in 51 percutaneous transluminal coronary angioplasty patients. Data from this group were compared to a matched sample of 51 angioplasty patients whose intravenous heparin therapy was titrated using activated partial thromboplastin time. RESULTS: No differences in procedural, early or late complications were found between the groups. The cost of managing heparin therapy with low-range activated clotting time was less than with activated partial thromboplastin time. CONCLUSION: These results suggest that titrating heparin therapy based on bedside low-range activated clotting time for the angioplasty patients in this sample was as safe as with activated partial thromboplastin time. Use of bedside low-range activated clotting time saved money for the hospital.

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