NCT04555785 Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor
| NCT ID | NCT04555785 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2022-04-01 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Martin Siegemund, Prof. Dr. MD
STUDY CHAIR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT04555785 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04555785 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04555785 currently recruiting?
Yes, NCT04555785 is actively recruiting participants. Contact the research team at martin.siegemund@usb.ch for enrollment information.
Where is the NCT04555785 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT04555785 clinical trial?
NCT04555785 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Martin Siegemund, Prof. Dr. MD at University Hospital, Basel, Switzerland. The trial plans to enroll 120 participants.