Enhancing platelet function to reduce bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of high-normal doses of Wilate®, a treatment containing von Willebrand Factor, compared to a placebo in patients experiencing bleeding. The goal is to assess whether this treatment can reduce blood loss, the need for transfusions, and improve patient outcomes such as length of hospital stay and mortality rates. Patients admitted to the intensive care unit who require platelet transfusions during or after surgery will be included in the study. The research aims to enhance platelet adhesion and function in the presence of von Willebrand Factor.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital Basel
  Basel, Switzerland Recruiting

Study contacts

• Study coordinator: Martin Siegemund, Prof. Dr. MD
• Email: martin.siegemund@usb.ch
• Phone: 0041613286414

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.