Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04555785

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

Led by University Hospital, Basel, Switzerland · Updated on 2024-12-11

120

Participants Needed

1

Research Sites

343 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age �3E�3D 18 years
  • Admission to intensive care unit
  • Need for 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
Not Eligible

You will not qualify if you...

  • Receiving Factor VIII concentrate before study inclusion (Haemate �AE)
  • Women who are pregnant or breastfeeding
  • Participation in another investigational drug study within 30 days before or during this study
  • Overt Disseminated Intravascular Coagulation (DIC)
  • Heparin-induced Thrombocytopenia (HIT)
  • Thrombotic Thrombocytopenic Purpura (TTP) or Haemolytic Uremic Syndrome (HUS)
  • Idiopathic thrombocytopenic purpura (ITP)
  • Sepsis
  • Known inherited thrombocytopathies
  • Known von Willebrand disease or Haemophilia A
  • Known hemato-oncological diseases
  • Previous enrollment in this study
  • Contraindications to the study drug class, such as known hypersensitivity or allergy to the investigational product

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Basel

Basel, Switzerland, 4031

Actively Recruiting

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Research Team

M

Martin Siegemund, Prof. Dr. MD

CONTACT

A

Andrea Blum, med. pract.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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