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-CZ
- 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 enrollment 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 who is able to assess the nature, significance and scope of the clinical trial. If the subject is in emergency situation and temporarily incapable of consent, the consent of a legal representative or authorised representative will be waived if permitted under applicable local regulations/ethics committee recommendations. Consent must be obtained for further participation in the clinical trial as soon as this is possible and reasonable for the subject to do so to confirm understanding/willingness to participate in the clinical study and ability to comply with study procedures and the study visit schedule. Males or females aged =2 weeks
2.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.
3.Have adequate renal function: estimated glomerular filtration rate (eGRF) = 15 mL/min/1.73 m²
4.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.
5.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 during the entire VKA use and for one month after cessation of its use. Subjects should continue with adequate contraception after the study end if they continue with VKA use. (Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for = 3 months prior to entry into the study.)
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
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 enrollment 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 enrollment
5.Lumbar puncture or spinal/epidural catheter placement within the past 48 hours
6.Severe hepatic impairment (Child-Pugh Class C) Note: in patients with suspected/confirmed severe liver disease, Child-Pugh C stage of liver disease must be excluded before start of treatment. For calculating Child-Pugh score, laboratory parameters in the patient file on INR, prothrombin time, serum albumin and total bilirubin taken can be taken, if they have been obtained within the last 48 hours before randomization. In all other patients these parameters have to be measured before start of treatment to identify potential exclusion criteria.
7.Active bleeding
8.Subjects with the following conditions to be excluded if alternative antithrombotic treatments are available:
(i)Severe hemorrhagic diathesis,
(ii)Traumatic damage to the central nervous system
(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;Timepoint(s) of evaluation of this end point: Day 44;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>
- Secondary Outcome Measures
Name Time Method