Ignite Creation Date:
2024-05-05 @ 11:02 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01246011
Status:
TERMINATED
Last Update Posted:
2017-11-17
First Post:
2010-11-17
Brief Title:
Significance of Antibodies to HeparinPlatelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Significance of Antibodies to HeparinPlatelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Status:
TERMINATED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was too slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
HeparinPlatelet 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 no signs or symptoms of Heparin Induced Thrombocytopenia HIT will be randomized to receive argatroban and warfarin 30 subjects with a positive antibody result and no signs or symptoms of HIT will be randomized to receive no treatment 30 subjects with a negative antibody result will also be followed in the study All subjects will have a cardiac CT scan at about 30 days post surgery to measure the patency of their coronary artery bypass vein grafts This study will evaluate if treating patients who have heparin PF4 antibodies post-CABG with argatroban and warfarin has any effect on the short-term patency of coronary artery bypass vein grafts
Detailed Description:
This is a prospective randomized single center study Patients scheduled for CABG will be screened and enrolled Subjects positive for heparinPF4 antibody within 24 h after CABG and without clinical suspicion of HIT will be randomized into one of two groups An additional 30 patients with negative antibody titers will serve as a control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None