NCT00237328

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,015

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

2.8 years

First QC Date

October 11, 2005

Last Update Submit

February 22, 2013

Conditions

Thrombosis

Keywords

Heparin resistanceBlood clottingHeart surgeryCardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • Thrombotic events compatible with HIT

    one year

Secondary Outcomes (1)

  • antibody positibe status post operative day 5 and day 30

    one year

Interventions

HeparinDRUG

Heparin will be used as the intra-operative anticoagulant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Scheduled for cardiac bypass surgery at Duke University Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic, Rochester

Rochester, Minnesota, 55905, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Publications (5)

  • Warkentin TE, Greinacher A. Heparin-induced thrombocytopenia: recognition, treatment, and prevention: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):311S-337S. doi: 10.1378/chest.126.3_suppl.311S.

    PMID: 15383477BACKGROUND

  • Alsoufi B, Boshkov LK, Kirby A, Ibsen L, Dower N, Shen I, Ungerleider R. Heparin-induced thrombocytopenia (HIT) in pediatric cardiac surgery: an emerging cause of morbidity and mortality. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2004;7:155-71. doi: 10.1053/j.pcsu.2004.02.024.

    PMID: 15283365BACKGROUND

  • Pouplard C, May MA, Iochmann S, Amiral J, Vissac AM, Marchand M, Gruel Y. Antibodies to platelet factor 4-heparin after cardiopulmonary bypass in patients anticoagulated with unfractionated heparin or a low-molecular-weight heparin : clinical implications for heparin-induced thrombocytopenia. Circulation. 1999 May 18;99(19):2530-6. doi: 10.1161/01.cir.99.19.2530.

    PMID: 10330384BACKGROUND

  • Warkentin TE, Greinacher A. Heparin-induced thrombocytopenia and cardiac surgery. Ann Thorac Surg. 2003 Dec;76(6):2121-31. doi: 10.1016/j.athoracsur.2003.09.034.

    PMID: 14667668BACKGROUND

  • Williams RT, Damaraju LV, Mascelli MA, Barnathan ES, Califf RM, Simoons ML, Deliargyris EN, Sane DC. Anti-platelet factor 4/heparin antibodies: an independent predictor of 30-day myocardial infarction after acute coronary ischemic syndromes. Circulation. 2003 May 13;107(18):2307-12. doi: 10.1161/01.CIR.0000066696.57519.AF. Epub 2003 Apr 21.

    PMID: 12707235BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

Heparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Thomas Ortel, MD, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2005

First Posted

October 12, 2005

Study Start

June 1, 2006

Primary Completion

March 1, 2009

Study Completion

July 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

US(4)