Study Stopped
The study was discontinued early due to inadequate patient enrollment. No patients were enrolled.
Bivalirudin PCI Registry in Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome (HIT/HITTS) Patients
Bivalirudin PCI Registry in HIT/HITTS Patients
1 other identifier
interventional
N/A
1 country
1
Brief Summary
To monitor the frequency of the development of thrombocytopenia in patients with Heparin Induced Thrombocytopenia/Heparin Induced Thrombocytopenia and Thrombosis Syndrome receiving bivalirudin during Percutaneous Coronary Intervention
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 22, 2008
CompletedFirst Posted
Study publicly available on registry
September 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2010
CompletedOctober 19, 2020
October 1, 2020
1 year
September 22, 2008
October 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Platelet counts
6, 12, 24, 48 Hours
Study Arms (1)
1
EXPERIMENTALPatients with HIT/HITTS who require anticoagulation for PCI
Interventions
Bivalirudin; 0.75mg/kg/h IV bolus followed immediately by 1.75 mg/kg/h infusion for the duration of the procedure
Eligibility Criteria
You may qualify if:
- Clinically Documented History of HIT/HITTS
- Suspicion of HIT/HITTS
You may not qualify if:
- Bleeding Diathesis
- Ischemic Stroke
- Chronic Thrombocytopenia
- Hematologic Malignancy
- Contraindication to bivalirudin
- Pregnant or nursing mothers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Duke Clinical Research Institute
Durham, North Carolina, 27705, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Ohman, MD
Duke Clinical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2008
First Posted
September 25, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2009
Study Completion
May 10, 2010
Last Updated
October 19, 2020
Record last verified: 2020-10