Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor

2020-02106

Assessment of high-normal dosage of Wilate ® compared to placebo administered in combination with platelets to assess reduction of amount of blood loss, need of transfusion products and outcome (length of stay, mortality) in patients with bleeding in comparison.

2022-04-01

2025-11-01

2026-11-01

Recruiting

Early phase I

120

Inclusion Criteria: * Age ≥ 18 years * Admission to intensive care unit * Patients needing platelet transfusion during or after surgery with or without prior treatment with single or dual antiplatelet agents (ASS, Prasugrel, Clopidogrel, Ticagrelor) * Consent by the patient or a family member in addition to the consent of an independent ICU physician Exclusion Criteria: * Patients receiving Factor VIII concentrate before inclusion of the study (Haemate ®) * Women who are pregnant or breastfeeding * Participation in another study with an investigational drug within the 30 days preceding and during the present study * Overt Disseminated Intravascular Coagulation (DIC) * Heparin-induced Thrombocytopenia (HIT) * Thrombotic Thrombocytopenic Purpura (TTP) or Haemolytic uremic Syndrome (HUS) * Idiopathic thrombocytopenic purpura (ITP) * Sepsis * Patients with known inherited thrombocytopathies * Patients with known von Willebrand disease or Haemophilia A * Patients with known hemato-oncological diseases * Previous enrolment into the current study * Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-12-07