Back to resultsFondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)
Primary Purpose
Heparin-Induced Thrombocytopenia
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
fondaparinux
argatroban or lepirudin
Sponsored by
About this trial
This is an interventional treatment trial for Heparin-Induced Thrombocytopenia focused on measuring heparin-Induced thrombocytopenia, fondaparinux
Eligibility Criteria
Inclusion Criteria:
- Male or female at least 18 years of age;
- If female of childbearing potential, negative pregnancy test result;
- Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
- Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).
Exclusion Criteria:
- Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
- Pregnancy or lactating;
- Blood dyscrasia other than HIT;
- History of thrombocytopenia associated with fondaparinux;
- Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
- Active bleeding of GI tract, GU tract, CNS or respiratory tract;
- Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;
- Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;
- Hypersensitivity or contraindication to warfarin or fondaparinux.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Fondaparinux
Direct thrombin inhibitor
Outcomes
Primary Outcome Measures
Platelet count recovery
Secondary Outcome Measures
Recurrent thromboembolic complications
Full Information
NCT ID
NCT00603824
First Posted
January 4, 2008
Last Updated
August 12, 2019
Sponsor
Methodist Healthcare
Collaborators
University of Tennessee
1. Study Identification
Unique Protocol Identification Number
NCT00603824
Brief Title
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)
Official Title
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Withdrawn
Why Stopped
PI relocated
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Methodist Healthcare
Collaborators
University of Tennessee
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heparin-Induced Thrombocytopenia
Keywords
heparin-Induced thrombocytopenia, fondaparinux
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Fondaparinux
Arm Title
B
Arm Type
Active Comparator
Arm Description
Direct thrombin inhibitor
Intervention Type
Drug
Intervention Name(s)
fondaparinux
Other Intervention Name(s)
Arixtra
Intervention Description
fondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if >100 kg
Intervention Type
Drug
Intervention Name(s)
argatroban or lepirudin
Other Intervention Name(s)
Refludan
Intervention Description
continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range
Primary Outcome Measure Information:
Title
Platelet count recovery
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Recurrent thromboembolic complications
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female at least 18 years of age;
If female of childbearing potential, negative pregnancy test result;
Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).
Exclusion Criteria:
Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
Pregnancy or lactating;
Blood dyscrasia other than HIT;
History of thrombocytopenia associated with fondaparinux;
Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
Active bleeding of GI tract, GU tract, CNS or respiratory tract;
Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;
Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;
Hypersensitivity or contraindication to warfarin or fondaparinux.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bob L Lobo, Pharm.D.
Organizational Affiliation
Methodist University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sohail Minhas, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)
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