Status:
TERMINATED
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Coronary Artery Bypass Graft Surgery
Presence of Heparin/Platelet Factor 4 Antibody
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery. 30 subjects with a positive antibody result and n...
Detailed Description
This is a prospective, randomized, single center study. Patients scheduled for CABG will be screened and enrolled. Subjects positive for heparin/PF4 antibody within 24 h after CABG and without clinica...
Eligibility Criteria
Inclusion
- Patients scheduled for CABG (males or non-pregnant females)
- \> 18 years old with at least one vein graft planned
- Able to provide written informed consent
Exclusion
- Patients who, in the investigator's or attending surgeon's opinion, are unsuitable for anticoagulation due to their clinical status
- Documented history of allergy to iodinated contrast media, warfarin, or argatroban
- Chronic renal impairment with CrCl\<60 ml/min
- Recent bleeding episode
- Congestive Heart Failure (EF\< 30%)
- Bleeding diathesis or known thrombophilic disorder
- Atrial fibrillation or other condition requiring anticoagulation at the time of enrollment
- Documented history of heparin induced thrombocytopenia
- Clinical suspicion of HIT at the time of randomization, defined as 50% decrease in Platelet count from last heparin exposure or Platelet count \<100,000/ml
- Hepatic dysfunction (defined as LFTs \> 3 times the upper limit of normal)
- Patients with a history of bleeding complications post-CABG
- Hemorrhagic stroke
- Gastrointestinal bleeding
- Requirement for fresh frozen plasma
- Recent central nervous system or ophthalmic surgery
- Aneurysm
- History of psychosis or senility
- Malignant hypertension
- Clinically significant pericarditis or pericardial effusion
- Bacterial endocarditis
- Hematocrit \< 24%
- Valve replacement or repair at time of CABG
- Subjects with signs or symptoms of possible Transient Ischemic Attack or stroke
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01246011
Start Date
November 1 2010
End Date
July 1 2011
Last Update
November 17 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02474