Enhancement of the Haemostatic Effect of Platelets in the Presence of High Normal Concentrations of Von Willebrand Factor (Will-Plate)

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ClinicalTrials.gov Identifier: NCT04555785

Recruitment Status : Recruiting

First Posted : September 21, 2020

Last Update Posted : April 14, 2022

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

University Hospital, Basel, Switzerland

Tracking Information

First Submitted Date ^ICMJE

August 25, 2020

First Posted Date ^ICMJE

September 21, 2020

Last Update Posted Date

April 14, 2022

Actual Study Start Date ^ICMJE

April 1, 2022

Estimated Primary Completion Date

March 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of blood products [ Time Frame: 48 hours ]

Number of blood products (platelets, fresh frozen plasma (FFP), red blood cells (RBC))

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Von Willebrand Factor (vWF) is a key protein mediating platelet adhesion on the surface of damaged endothelia, initiating platelet-platelet aggregation and supporting platelet activation. It plays also an important role in protecting FVIII from early activation and clearance . The product's included coagulation factor VIII acts in in the activated form like the regular factor VIIIa. It takes part in the coagulation amplification by activating factor X to Xa together with factor IVa. Activation of factor X results in generating thrombin out of prothrombin. Wilate® is approved in Switzerland for prophylaxis and treatment of bleeding in patients suffering from von Willebrand disease and Haemophilia A.

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Bleeding

Intervention ^ICMJE

Drug: 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.
Other: Placebo
Empty placebo will be given with platelets in cases of severe bleeding.

Study Arms ^ICMJE

Experimental: Platelet transfusion with Wilate ®
Intervention: Drug: Wilate
Placebo Comparator: Platelet transfusion with Placebo
Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

March 2025

Estimated Primary Completion Date

March 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Martin Siegemund, Prof. Dr. MD	0041613286414	martin.siegemund@usb.ch
Contact: Andrea Blum, med. pract.	0041796903886	andrea.blum@hotmail.ch

Listed Location Countries ^ICMJE

Switzerland

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04555785

Other Study ID Numbers ^ICMJE

2020-02106

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Responsible Party

University Hospital, Basel, Switzerland

Study Sponsor ^ICMJE

University Hospital, Basel, Switzerland

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Martin Siegemund, Prof. Dr. MD

University Hospital, Basel, Switzerland

PRS Account

University Hospital, Basel, Switzerland

Verification Date

April 2022

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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