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Risk of Developing Antibodies to Heparin-PF4 After Heart Surgery
This study is currently recruiting participants.
Verified by Office of Rare Diseases (ORD), December 2008
First Received: October 11, 2005   Last Updated: December 17, 2008   History of Changes
Sponsors and Collaborators: Office of Rare Diseases (ORD)
Rare Diseases Clinical Research Network
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00237328
  Purpose

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

MedlinePlus related topics: Blood Thinners Heart Surgery Surgery
Drug Information available for: Heparin
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: The Incidence of Thromboembolic Events in Patients With Antibodies to Heparin-PF4 After Cardiac Bypass

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

Biospecimen Retention:   None Retained

Biospecimen Description:

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)
Intervention Details:
    Drug: Heparin
    Heparin will be used as the intra-operative anticoagulant
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals undergoing cardiac bypass surgery with heparin as the intra-operative anticoagulant at Duke University Hospital.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237328

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

Locations
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            
Sponsors and Collaborators
Rare Diseases Clinical Research Network
Investigators
Principal Investigator: Thomas Ortel, MD, PhD Duke University
  More Information

Publications:
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

Keywords provided by Office of Rare Diseases (ORD):
Heparin resistance
Blood clotting
Heart surgery
Cardiopulmonary bypass

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009