Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

End-stage Heart Failure Clinical Trial

— HemostVAD  

Official title:

Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966313
• Other study ID #: 7287
• Status: Recruiting
• Start date: June 21, 2019
• Est. completion date: June 21, 2022

Study information

• Verified date: April 2020
• Source: University Hospital, Strasbourg, France
• Contact: Charles TACQUARD
• Phone: 0369551608
• Email: charlesambroise.tacquard[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Preoperative anemia less than 7 g/dL

• Subject under the protection of justice

• Subject under guardianship or curatorship

• Pregnancy

• Breastfeeding

Related Conditions & MeSH terms

• End-stage Heart Failure
• Heart Failure

Intervention

Device:
• ventricular assist device implantation
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

Locations

Country	Name	City	State
France	Hopitaux Universitaire de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Von Willebrand Factor activity	Change of Von Willebrand Factor from Baseline to 48 hours	From Baseline to 48 hours