Last updated on January 2020

An Open-Label Randomised Active Controlled Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects With Acute HIT


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Heparin-induced Thrombocytopenia
  • Age: - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • At the time of enrolment subjects are eligible to be included in the study only if all of the following criteria apply:
    1. Signed written informed consent by the subject, or if the subject is temporarily unable to do so, then consent will be sought from a family member, or a legally accepted representative as per local regulations
    2. Males or females aged 2 weeks
    3. Subjects with suspected HIT by 4Ts of >3 and with reduction of platelet count of 30% at either:
    4. Between Day 4 and 14 of the start of heparin exposure or
    5. At Day 1 of heparin exposure with pre-treatment with heparin within the last 30 days, with or without thrombosis.
    6. Have adequate renal function: Glomerular filtration rate 15 mL/min/1.73 m
    7. Male participants:

A male participant must agree to use contraception during the treatment period and for at least 5 days after the last dose of study intervention and refrain from donating sperm during this period.

6. Female participants:

A female participant is eligible to participate if 1 of the following conditions

applies
  1. Not a woman of childbearing potential OR
  2. A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days corresponding to time needed to eliminate study intervention. (Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for 3 months prior to entry into the study.)
  3. Understanding/willingness by the subject or his/her legally accepted representative to participate in the clinical study and ability to comply with study procedures and the study visit schedule

Exclusion Criteria:

  • At the time of enrolment subjects are excluded from the study if any of the following criteria apply:
    1. Premature infants (corrected age <37 weeks gestational age)
    2. Expectation of cardiac surgery within the next 44 days
    3. Life expectancy clearly less than the 44 days
    4. Fibrinolytic therapy <24 hours before enrolment
    5. Lumbar puncture or spinal/epidural catheter placement within the past 48 hours
    6. Severe hepatic impairment (Child-Pugh Class C)
    7. Active bleeding
    8. Subjects with the following conditions to be excluded if alternative antithrombotic treatments are available:

(i) Severe hemorrhagic diathesis, (ii) Damage to the central nervous system (iii) Brain, spinal or ophthalmologic surgery are to be excluded if alternative antithrombotic treatments are available.

(iv) Active stomach/duodenal ulcers or active peptic ulcer unless this ulcer is the cause of the surgical procedure

9. An unexplained activated partial thromboplastin time (aPTT) > 2 x the normal range

10. A hemorrhagic cerebrovascular accident within the previous 3 months

11. Severe, uncontrolled hypertension defined as blood pressure >180/110 mmHg

12. Diabetic retinopathy

13. Acute bacterial endocarditis

14. Expectation of a long-term (> 3 weeks) hemodialysis requirement before the end of the acute treatment

15. Hypersensitivity to the active substances or to any of the excipients

16. Hypersensitivity to sulphite

17. Any investigational drug(s) use within 4 weeks preceding Screening or anticipated use during the course of the study

18. Pregnant or breastfeeding woman

19. Use of intra-aortic balloon pump, or ventricular assist device

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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