CompletedPhase 2

Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II

France20 participantsStarted 2009-04

Plain-language summary

The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy

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: * Subjects aged \>= 18 years * Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study * Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation * Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative Exclusion Criteria: * Uncontrolled bleeding * Severe hepatic impairment (Child-Pugh Class C) * Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol) * Pregnancy (exclusion by routine urine test) * Lactating woman

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

Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation

Timeframe: During and 30 days after argatroban treatment

All-cause Death

Timeframe: During and 30 days after argatroban treatment

Death Related to Heparin-induced Thrombocytopenia (HIT)

Timeframe: During and 30 days after argatroban treatment

Number of Patients With Thrombosis (New and Extended)

Timeframe: During and 30 days after argatroban treatment

Number of Patients With Unplanned Amputation

Timeframe: During and 30 days after argatroban treatment

Number of Patients With Major or Minor Bleeding

Timeframe: During and 30 days after argatroban treatment

Number of Patients With Platelet Count Recovery

Timeframe: Day 3

Trial details

NCT IDNCT00861692

SponsorTanabe Pharma Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-02

Results submitted2015-11-17

View on ClinicalTrials.gov More Heparin-induced Thrombocytopenia Type II trials

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.

What they're measuring

Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation

Timeframe: During and 30 days after argatroban treatment

All-cause Death

Timeframe: During and 30 days after argatroban treatment

Death Related to Heparin-induced Thrombocytopenia (HIT)

Timeframe: During and 30 days after argatroban treatment

Number of Patients With Thrombosis (New and Extended)

Timeframe: During and 30 days after argatroban treatment

Number of Patients With Unplanned Amputation

Timeframe: During and 30 days after argatroban treatment

Number of Patients With Major or Minor Bleeding

Timeframe: During and 30 days after argatroban treatment

Number of Patients With Platelet Count Recovery

Timeframe: Day 3