WithdrawnPhase 4

Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)

Stopped: PI relocated

0Started 2008-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Platelet count recovery

Timeframe: 5 days

Trial details

NCT IDNCT00603824

SponsorMethodist Healthcare - Memphis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-07

View on ClinicalTrials.gov More Heparin-Induced Thrombocytopenia trials