Phase III, randomized, double-blind, multicentre clinical trial on clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components.
- Conditions
- ThrombocytopeniaMedDRA version: 20.0 Level: HLT Classification code 10043555 Term: Thrombocytopenias System Organ Class: 100000004851Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-001035-20-DE
- Lead Sponsor
- DRK-Blutspendedienst NSTOB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 166
- Haemato-oncological patients with thrombocytopenia or expected to become
thrombocytopenic;
- Expected to receive = 1PLT transfusions during their hospital stay;
- Age = 18 years;
- Written Informed Consent.
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 116
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
- Known immunological refractoriness to PLT transfusions, i.e. HLA and/or HPA
alloimmunization (documented in the patient’s medical record);
- History or diagnosis of an autoimmune disease affecting haemostasis;
- Acute or chronic Disseminated Intravascular Coagulation (DIC);
- History or diagnosis of Thrombotic Thrombocytopenic Purpura or Haemolytic Uremic Syndrome;
- Severe uncontrolled infection;
- Positive serum or urine pregnancy test;
- Lactation;
- Simultaneous participation in another interventional Trial;
- Previous inclusion in this trial;
- Acute promyelocytic leukemia (AML, FAB subtype M3)
- Active bleeding at time of enrolment requiring one or more RBC transfusions and/or therapeutic platelet transfusions;
- Splenomegaly defined as a palpable spleen felt more than 4 cm below costal margin;
- History of severe anaphylactic transfusion criteria;
- Legal incapacity or other circumstances preventing the patient from understanding the nature, meaning and implications of the clinical Trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method