Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

NCT03966313 | Terminated

• 1 other identifier: 7287
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

End-stage Heart Failure

Outcome Measures

Primary Outcomes (1)

• Von Willebrand Factor activity

  Change of Von Willebrand Factor from Baseline to 48 hours

  From Baseline to 48 hours

Interventions

ventricular assist device implantation DEVICE

Blood sampling in patients under surgery for ventricular assist device implantation at five time points: * After anesthetic induction * Before starting the device * 2h, 6h and 48h after starting the device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with end-stage heart failure (acute or chronic) under surgery for implantation of a ventricular assist device.

You may qualify if:

• 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

You may not qualify if:

• Preoperative anemia less than 7 g/dL
• Subject under the protection of justice
• Subject under guardianship or curatorship
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hopitaux Universitaire de Strasbourg

Strasbourg, 67091, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Whole blood * Plasma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 29, 2019
• Study Start: June 21, 2019
• Primary Completion: April 13, 2024
• Study Completion: April 13, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)