Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT00861692
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00861692
Study Brief:
Protocol Section:
NCT00861692