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
Thrombosis Thoracic Surgery	Drug: Heparin

Further study details as provided by Office of Rare Diseases (ORD):

Expected Total Enrollment:  800

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 above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Scheduled for cardiac bypass surgery at Duke University Hospital

Exclusion Criteria:

• Plans to receive warfarin during the post-operative inpatient stay
• Plans to receive a full anticoagulant dose of low-molecular weight heparin during the post-operative inpatient stay
• Plans to receive a full anticoagulant dose of unfractionated heparin during the post-operative inpatient stay
• Use of any drug other than unfractionated heparin for anticoagulation during cardiopulmonary bypass
• Warfarin, heparin, or low-molecular weight heparin administered during a readmission to the hospital for a reason other than one of this study''''s outcomes does not constitute criteria for exclusion

Please refer to this study by ClinicalTrials.gov identifier  NCT00237328

Thomas Ortel, MD, PhD      919-684-5350    ortel001@mc.duke.edu

North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States

Study chairs or principal investigators

Thomas Ortel, MD, PhD,  Principal Investigator,  Duke University   

Study ID Numbers:  5U54HL077878-02; VCRC5502
Last Updated:  December 29, 2005
Record first received:  October 11, 2005
ClinicalTrials.gov Identifier:  NCT00237328
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10