NCT03613584

Brief Summary

During treatments with extracorporeal circuits such as extracorporeal membrane oxygenation (ECMO) degradation of high molecular weight (HMW) of von Willebrand factor (vWF) multimers occur leading to an acquired von Willebrand disease. This disease is associated with increased bleeding and requirement for the transfusion with allogenic blood products especially packed red blood cells (PRBCs). A continuous treatment with von Willebrand factor concentrate (vWFC) may restore the multimers and bleeding can be avoided. Therefore a randomized, double-blind, prospective, controlled, two-arm clinical trial was designed, comparing patients receiving vWFC versus placebo.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2018

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

March 22, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2021

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

2.9 years

First QC Date

March 22, 2018

Last Update Submit

March 11, 2020

Conditions

Acquired Von Willebrand Disease

Outcome Measures

Primary Outcomes (1)

  • Transfusion requirement of PRBC

    Difference in the number of red blood cells concentrates between the treatment arms per day

    Between start of IMP (Visit 2) until 24 hours after IMP-start (Visit 3)

Secondary Outcomes (13)

  • Transfusion requirements of other allogenic blood products

    Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)

  • Requirements of coagulation factor concentrates

    Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)

  • Number of vWF-HMW multimer bands

    Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)

  • Assessment of thromboelastometry

    Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)

  • Changes in thrombocytes

    Between start of ECMO (Visit 1) and 36 hours after ECMO Stop (Visit 7)

  • +8 more secondary outcomes

Study Arms (2)

Group W (von Willebrand factor concentrate)

ACTIVE COMPARATOR

The patient receives von Willebrand factor concentrate (vWFC) as a bolus of 25 IU/kg followed by a continuous infusion of 50 IU/kg/24h until the weaning from ECMO is completed or if ECMO is needed longer than 7 days, the administration of the Investigational Medicinal Product (IMP) will be stopped on the 7th day.

Drug: Von Willebrand Factor

Group S (standard therapy with saline solution)

PLACEBO COMPARATOR

The patient receives the standard therapy plus an additional volume of saline solution equivalent to the amount of von Willebrand factor concentrate (vWFC) the patient would receive in Group W to keep the blind. The volume is given according to the VWFC-solution (0.25 ml/kg BW) what would be resulting from the patient's weight followed by a continuous saline infusion (0.50 ml/kg BW) until the weaning from ECMO is completed or if ECMO is needed longer than 7 days, the Investigational Medicinal Product (IMP) administration is stopped on the 7th day.

Drug: Saline Solution

Interventions

Von Willebrand FactorDRUG

Bolus and continuous infusion of the Investigational Medicinal Product (IMP) during extracorporeal membrane oxygenation (ECMO)

Group W (von Willebrand factor concentrate)
Saline SolutionDRUG

Bolus and continuous infusion of the Investigational Medicinal Product (IMP) during extracorporeal membrane oxygenation (ECMO)

Group S (standard therapy with saline solution)

Eligibility Criteria

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

You may qualify if:

  • Patients with the need of veno-arterial or veno-venous ECMO for a minimum of 48 hours
  • Age ≥ 18 years

You may not qualify if:

  • Patient with known thromboembolic event in the last 30 days
  • Inevitable lethal course
  • Severe Liver failure: Quick \< 30 %
  • Pregnancy
  • Patient with known refusal of a participation in this clinical trial
  • Active participation in another clinical trial
  • Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medical University Innsbruck / Department for Anesthesia and Intensive Care Medicine

Innsbruck, 6020, Austria

Location

Medical University Innsbruck / Department for General and Surgical Critical Care Medicine

Innsbruck, 6020, Austria

Location

Related Publications (3)

  • Tauber H, Streif W, Fritz J, Ott H, Weigel G, Loacker L, Heinz A, Velik-Salchner C. Predicting Transfusion Requirements During Extracorporeal Membrane Oxygenation. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):692-701. doi: 10.1053/j.jvca.2016.01.009. Epub 2016 Jan 11.

    PMID: 27321792BACKGROUND

  • Tauber H, Ott H, Streif W, Weigel G, Loacker L, Fritz J, Heinz A, Velik-Salchner C. Extracorporeal membrane oxygenation induces short-term loss of high-molecular-weight von Willebrand factor multimers. Anesth Analg. 2015 Apr;120(4):730-6. doi: 10.1213/ANE.0000000000000554.

    PMID: 25565317BACKGROUND

  • Velik-Salchner C, Eschertzhuber S, Streif W, Hangler H, Budde U, Fries D. Acquired von Willebrand syndrome in cardiac patients. J Cardiothorac Vasc Anesth. 2008 Oct;22(5):719-24. doi: 10.1053/j.jvca.2007.05.013. Epub 2007 Aug 3. No abstract available.

    PMID: 18922429BACKGROUND

MeSH Terms

Interventions

von Willebrand FactorSaline Solution

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The vWFC or placebo will be prepared by the local hospital pharmacy or independent nurses from another ward (on holidays and weekends). To keep the blinding for the treating physicians and the study team syringes and lines with light protection (orange color) will be used. So the color of the medication (colorless to slightly yellowish) cannot be distinguished.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2018

First Posted

August 3, 2018

Study Start

April 16, 2018

Primary Completion

March 10, 2021

Study Completion

March 10, 2021

Last Updated

March 12, 2020

Record last verified: 2020-03

Locations

AU(2)