The study evaluates 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-HR
- Lead Sponsor
- Aspen Global Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 508
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:
a) between day 4 and 14 of the start of heparin exposure or
b) 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/1.73 m2
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? no
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.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 CNS
(iii) brain, spinal or ophthalmologic surgery
(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
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 ischemic gut resection<br>;Timepoint(s) of evaluation of this end point: Day 44
- Secondary Outcome Measures
Name Time Method