Clinical Trials Logo
  1. Home
  2. Thrombosis
  3. NCT00237328

Risk of Developing Antibodies to Heparin-PF4 After Heart Surgery — HIT  

Thrombosis Clinical Trial

Official title:
The Incidence of Thromboembolic Events in Patients With Antibodies to Heparin-PF4 After Cardiac Bypass

Clinical Trial Summary

Heparin is a drug that is widely used to prevent and treat blood clotting. Individuals undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of them develop antibodies to the drug. This immune response can lead to the formation of blood clots, setting the stage for a potential heart attack or stroke. The purpose of this study is to evaluate how often an immune response to heparin leads to the formation of blood clots in individuals who have had heart surgery.

Clinical Trial Description

Heparin is a drug that is widely used to prevent and treat blood clotting. However, heparin can also cause serious adverse events. Individuals undergoing cardiopulmonary bypass surgery are administered and therefore exposed to high doses of heparin. Studies have shown that up to 61% of cardiac bypass patients develop elevated levels of antibodies to heparin-PF4 after surgery. This immune response may activate blood platelets, possibly resulting in a blood clot. These clots most often develop in the legs and lungs, and may lead to a heart attack or stroke. The frequency of such a reaction has yet to be determined definitively. This study will evaluate the incidence of an immune response to heparin-PF4 that leads to the formation of blood clots in individuals who have had heart surgery.

Participants in this study will be recruited prior to a scheduled cardiac bypass surgery. They will first complete a structured pre-operative interview to collect baseline measures on demographics, comorbidities, history of heparin exposures, and prior thromboembolic events. Immediately prior to surgery, a blood sample will be taken to assess the individual's platelet count and level of antibodies to heparin-PF4. Following the operation, participants will be followed daily to assess heparin exposure, platelet counts, and any blood clotting. Subsequent blood samples will be taken 5 days and 1 month following the surgery to again evaluate the individual's platelet count and level of heparin-PF4 antibodies. Additionally, participants will undergo a structured interview at 1 and 3 months post-surgery to evaluate the incidence of outcomes related to heparin-PF4 antibodies. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00237328
Study type Observational
Source Duke University
Contact
Status Completed
Phase N/A
Start date June 2006
Completion date July 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Recruiting NCT04398628 - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed NCT05426564 - Exploratory Assessment of the Quantra® System in Adult ECMO Patients
Not yet recruiting NCT05830916 - Diagnostic Role of Antiphospholipid Antibodies and Microparticles in Immune Thrombocytopenic Patients With Thrombosis
Recruiting NCT02972385 - Pharmacogenomics of Warfarin in Hispanics and Latinos
Completed NCT02917213 - Imaging Silent Brain Infarct And Thrombosis in Acute Myocardial Infarction
Completed NCT02439190 - CV004-007 Thrombosis Chamber Study Phase 1
Completed NCT02526628 - Thrombosis and Neurocognition in Klinefelter Syndrome
Completed NCT02341638 - Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects Phase 1
Completed NCT01855516 - Partial Thromboplastin Time After 72 Hours of Antithrombotic Prophylaxis Using Unfractionated Heparin N/A
Unknown status NCT00983112 - Evicel Study on the Peri-operative Bleeding in Total Knee Prothesis Surgery Phase 4
Completed NCT00412464 - Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis Phase 1
Completed NCT00346424 - Safety and Efficacy Study of Alfimeprase in Subjects With Occluded Central Catheters Phase 3
Completed NCT00479362 - Anticoagulant Therapy During Pacemaker Implantation Phase 4
Completed NCT00143715 - Oral Vitamin K for Warfarin Associated Coagulopathy Phase 3
Terminated NCT00303420 - Alteplase for Blood Flow Restoration in Hemodialysis Catheters Phase 4
Completed NCT00039858 - Evaluation of Argatroban Injection in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin Phase 4
Completed NCT00007410 - Genetic Architecture of Plasma T-PA and PAI-1 N/A
Completed NCT00000538 - Dietary Effects on Lipoproteins and Thrombogenic Activity Phase 3
Completed NCT00005436 - Lupus Cohort--Thrombotic Events and Coronary Artery Disease N/A