The study evaluate the safety and efficacy of danaparoid vs argatroban in treatment of subjects with acute heparin-induced-thrombocytopenia (HITSOVA)
- Conditions
- Acute Heparin-induced Thrombocytopenia (HIT)MedDRA version: 20.0Level: PTClassification code 10062506Term: Heparin-induced thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2018-002473-21-IT
- Lead Sponsor
- Aspen Global Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 7
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 unable to do so, then consent will be sought from a family member, or a legally accepted representative
2.Males or females aged =2 weeks
3.Subjects with suspected HIT by 4Ts of >3 and with reduction of platelet count of at least 30% between day 4 and 14 of heparin exposure or at Day 1 of heparin exposure with pre-treatment with heparin within the last 30 days, with or without thrombosis.
4.Have adequate renal function: Glomerular filtration rate = 15 mL/min
5.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:
a.Not a woman of childbearing potential
OR
b.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.)
7.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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 486
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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.Recent fibrinolytic therapy since the start of heparin therapy leading to the target indication for enrolment, HIT
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.An unexplained activated partial thromboplastin time (aPTT) > 2 x the normal range
9.Any cerebrovascular accident within the previous 3 months or has a history of haemorrhagic cerebrovascular incidence
10.Severe, uncontrolled hypertension defined as blood pressure >180/110 mmHg
11.Diabetic retinopathy
12.Acute bacterial endocarditis
13.Expectation of a long-term (> 3 weeks) haemodialysis requirement before the end of the acute treatment
14.Hypersensitivity to the active substances or to any of the excipients
15.Hypersensitivity to sulphite
16.Any investigational drug(s) use within 4 weeks preceding Screening or anticipated use during the course of the study
17.Pregnant or breastfeeding woman
18.Use of intra-aortic balloon pump, or ventricular assist device
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To show that for the treatment of subjects with acute heparin-induced thrombocytopenia (HIT) danaparoid use is not inferior to argatroban in terms of efficacy. ;Secondary Objective: To collect additional efficacy data<br>To describe the safety of danaparoid in comparison to argatroban;Primary end point(s): The primary efficacy endpoint (composite endpoint) is defined as treatment response at Day 44.<br>A subject will be considered a treatment responder, if none of the following events occur by Day 44:<br>•New or extended venous and/or arterial thrombosis, including gangrene/skin necrosis<br>Note: ‘thrombosis’ denotes venous and/or arterial here and throughout the protocol<br>•All-cause mortality <br>•Unplanned amputation, including ischaemic gut resection<br>;Timepoint(s) of evaluation of this end point: Day 44
- Secondary Outcome Measures
Name Time Method