Enhancing platelet function to reduce bleeding
Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor
This study is testing if a treatment called Wilate® can help patients in the ICU who are bleeding by improving their platelet function and reducing the need for blood transfusions.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT04555785 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are admitted to the intensive care unit and need platelet transfusions during or after surgery.
Not a fit: Patients with known von Willebrand disease, hemophilia A, or other specific coagulation disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce bleeding complications and improve recovery outcomes for patients requiring platelet transfusions.
How similar studies have performed: There is suggestive evidence from previous studies indicating that increasing von Willebrand Factor levels can enhance platelet function, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Study coordinator: Martin Siegemund, Prof. Dr. MD
- Email: martin.siegemund@usb.ch
- Phone: 0041613286414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.