NCT04555785

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
30mo left

Started Apr 2022

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Apr 2022Nov 2028

First Submitted

Initial submission to the registry

August 25, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

5.6 years

First QC Date

August 25, 2020

Last Update Submit

December 5, 2024

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

  • Number of blood products

    Number of blood products (fresh frozen plasma (FFP), red blood cells (RBC)) according to groups.

    48 hours

Study Arms (2)

Platelet transfusion with Wilate ®

EXPERIMENTAL
Drug: Wilate

Platelet transfusion with Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

WilateDRUG

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 Wilate ®
PlaceboOTHER

Empty placebo will be given with platelets in cases of severe bleeding.

Platelet transfusion with Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 38314243DERIVED

  • 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.

    PMID: 36670471DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

von Willebrand Factor

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Martin Siegemund, Prof. Dr. MD

    University Hospital, Basel, Switzerland

    STUDY CHAIR

Central Study Contacts

Martin Siegemund, Prof. Dr. MD

CONTACT

0041613286414martin.siegemund@usb.ch

Andrea Blum, med. pract.

CONTACT

0041796903886andrea.blum@hotmail.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

September 21, 2020

Study Start

April 1, 2022

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)