Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation
Key facts
- Who runs it
- University Hospital, Strasbourg, France
- Where
- France1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- People taking part
- 26 people enrolled
- Started
- 21 Jun 2019
- Ended
- 13 Apr 2024
- Type of study
- Observational
- Treatments tested
- ventricular assist device implantation
- Record updated
- 25 March 2025
- Why it stopped
- Due to inclusion difficulties following the evolution of surgical indications, which were clearly restricted, making patient inclusion too complex.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Age over 18 years old
- Who gave his consent to the study
- With an end-stage heart-failure
- Under surgery for a ventricular assist device implantation
- Scheduled or in emergency
Who cannot take part
- Preoperative anemia less than 7 g/dL
- Subject under the protection of justice
- Subject under guardianship or curatorship
- Pregnancy
- Breastfeeding
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.
Read full original descriptionShow less
The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.
Treatments tested
- ventricular assist device implantation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 25 March 2025