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Sponsors and Collaborators: |
Office of Rare Diseases (ORD) Rare Diseases Clinical Research Network |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00237328 |
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.
Condition | Intervention |
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Thrombosis Thoracic Surgery |
Drug: Heparin |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | The Incidence of Thromboembolic Events in Patients With Antibodies to Heparin-PF4 After Cardiac Bypass |
Estimated Enrollment: | 800 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Individuals undergoing cardiac bypass surgery with heparin as the intra-operative anticoagulant at Duke University Hospital.
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas Ortel, MD, PhD | 919-684-5350 | ortel001@mc.duke.edu |
United States, Minnesota | |
Mayo Clinic, Rochester | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Principal Investigator: John Heit, MD | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Thomas Ortel, MD, PhD 919-684-5350 ortel001@mc.duke.edu | |
Contact: Laurel Ericson 919-681-2668 erics002@mc.duke.edu | |
Principal Investigator: Thomas Ortel, MD, PhD | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Principal Investigator: Susan Martinelli, MD | |
United States, Wisconsin | |
University of Wisconsin | Recruiting |
Madison, Wisconsin, United States, 53706 | |
Contact: Karen Hansen, MD 608-256-1901 keh@medicine.wisc.edu | |
Contact: Andrea Jones 608-265-8162 anj@medicine.wisc.edu | |
Principal Investigator: Karen Hansen, MD |
Principal Investigator: | Thomas Ortel, MD, PhD | Duke University |
Responsible Party: | Duke University Health System ( Thomas Ortel, MD, PhD ) |
Study ID Numbers: | RDCRN 5801, 5U54HL077878-02 |
Study First Received: | October 11, 2005 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00237328 History of Changes |
Health Authority: | United States: Federal Government |
Heparin resistance Blood clotting Heart surgery Cardiopulmonary bypass |
Anticoagulants Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Thrombosis Calcium heparin Calcium, Dietary |
Embolism and Thrombosis Antibodies Fibrin Modulating Agents Embolism Platelet Factor 4 Heparin Immunoglobulins |
Anticoagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Thrombosis |
Pharmacologic Actions Calcium heparin Embolism and Thrombosis Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases Heparin |