Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor
NCT ID: NCT04555785
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
120 participants
INTERVENTIONAL
2022-04-01
2028-11-30
Brief Summary
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Detailed Description
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VWF is produced by the endothelial cells as a heterogeneous mixture of low and high molecular weight units. VWF is a ligand for receptors on the platelet surface and endothelial cells (GP1b-V-IX, αIIbβ3, αvβ3) mediating adhesion of platelets to each other or to the endothelium. Initial platelet adhesion is a crucial step in haemostatic functioning. Loss of platelets, vWF or blocking of these integrins due to the wide use of platelet aggregation inhibitors can cause bleeding. In case of severe blood loss, these conditions often result in mass transfusion.
There is suggestive evidence from an in-vitro flow chamber model and from treatment of patients with severe vWF deficiency that increasing the concentration of vWF onto normal or high normal levels can enhance platelet adhesion independent from platelet count. This might translate into a better haemostatic effect of administered platelet concentrates in the bleeding patient and less need for transfusion of blood products (platelet concentrates), especially in clinical conditions with a high probability of low platelet count and low vWF activities (e.g., heart surgery with extracorporeal circulation, ECMO).
To the best of our knowledge, no trial exists that investigated the effect of platelet transfusion in combination with the administration of balanced vWF in severe blood loss. The investigators hypothesize that simultaneous transfusion of platelets and balanced (1:1 vWF and FVIII) vWF compared to placebo reduces the overall need of transfusion of blood products.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Platelet transfusion with Wilate ®
Wilate
Wilate ® will be given with platelets in cases of severe bleeding. Wilate ® is a 1:1 balanced mixture of von Willebrand Factor (2'000 IU) and Coagulation factor VIII (2'000 IU) and as such has anti-haemorrhagic potential. It is extracted from plasma, freeze-dried and virus-inactivated.
Platelet transfusion with Placebo
Placebo
Empty placebo will be given with platelets in cases of severe bleeding.
Interventions
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Wilate
Wilate ® will be given with platelets in cases of severe bleeding. Wilate ® is a 1:1 balanced mixture of von Willebrand Factor (2'000 IU) and Coagulation factor VIII (2'000 IU) and as such has anti-haemorrhagic potential. It is extracted from plasma, freeze-dried and virus-inactivated.
Placebo
Empty placebo will be given with platelets in cases of severe bleeding.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Martin Siegemund, Prof. Dr. MD
Role: STUDY_CHAIR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Martin Siegemund, MD
Role: primary
Alexa Hollinger, MD
Role: backup
References
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Ledergerber K, Hollinger A, Zimmermann S, Todorov A, Trutmann M, Gallachi L, Gschwandtner LA, Ryser LA, Gebhard CE, Bolliger D, Buser A, Tsakiris DA, Siegemund M. Impact of Additional Administration of von Willebrand Factor Concentrates to Thrombocyte Transfusion in Perioperative Bleeding in Cardiac Surgery. Transfus Med Hemother. 2023 Jul 11;51(1):22-31. doi: 10.1159/000530810. eCollection 2024 Feb.
Herrmann G, Blum A, Bolliger D, Achermann R, Estermann A, Gebhard CE, Henn A, Huber J, Singh J, Todorov A, Zehnder T, Zellweger N, Buser A, Tsakiris DA, Hollinger A, Siegemund M. Enhancement of the haemostatic effect of platelets in the presence of high normal concentrations of von Willebrand factor for critically ill patients needing platelet transfusion-a protocol for the will-plate randomised controlled trial. Trials. 2023 Jan 20;24(1):47. doi: 10.1186/s13063-022-06876-8.
Other Identifiers
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2020-02106
Identifier Type: -
Identifier Source: org_study_id