NCT00603824WithdrawnPhase 4
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Methodist Healthcare
- Primary Endpoint
- Platelet count recovery
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
A
Experimental
Fondaparinux
Intervention: fondaparinux (Drug)
B
Active Comparator
Direct thrombin inhibitor
Intervention: argatroban or lepirudin (Drug)
Outcomes
Primary Outcomes
Platelet count recovery
Time Frame: 5 days
Secondary Outcomes
- Recurrent thromboembolic complications(4 weeks)
Investigators
Similar Trials
Terminated
Phase 2
Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)Heparin-Induced ThrombocytopeniaNCT00673439University of Louisville3
Unknown
Phase 3
Fondaparinux to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery: The Fonda CABG StudyCoronary Bypass Graft Failure/OcclusionNCT00474591Hamilton Health Sciences Corporation100
Unknown
Phase 4
Safety and Efficacy of Heparin and Nadroparin in the Acute Phase of Ischemic StrokeAcute Ischemic StrokeNCT01862978University Hospital, Martin150
Terminated
Phase 3
Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU PatientsVenous ThromboembolismNCT00493896Eastern Virginia Medical School27
Completed
Phase 4
Fondaparinux in Critically Ill Patients With Renal FailureVenous ThromboembolismNCT01467583Wayne State University32