Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

Heart Failure Clinical Trial

— PHAM  

Official title:

Prevention of Hemorrhage After Implantation of Mechanical Circulatory Support

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02488525
• Other study ID #: 2015_06
• Secondary ID: 2015-001231-20PH
• Status: Terminated
• Phase: Phase 3
• Start date: January 20, 2016
• Est. completion date: September 5, 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Main objective of the study is to demonstrate that a prophylactic treatment with VWF factor concentrate after implantation of continuous-flow left ventricular assist device (CF-LVAD) reduces the frequency of clinically significant bleeding within 3 months after implantation in comparison to the usual care. Adult patients with functional defects of VWF measured after implantation of continuous LVAD are randomly assigned to prophylactic treatment.

Description:

This time point was chosen because the bleeding events are maximal within the first 3 months after implantation.

• Adult patients > 18 years who need a CF-LVAD due to advanced heart failure.

• Functional To determine the potential indication of Wilfactin® in the field of CF-LVAD and avoid widespread use and to establish evidence-based recommendation To improve the knowledge of the role of VWF concentrate in bleeding and angiogenesis after CF-LVAD implantation and to provide some results about mechanism involved angiogenesis or hemostasis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: September 5, 2018
• Est. primary completion date: September 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients > 18 years who need a CF-LVAD due to advanced heart failure.

• Functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >180 sec and or VWF:Act/VWF:Ag= 0.7)

• Informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)

Exclusion Criteria:

• Treatment with Wilfactin® within the last seven days

• Previous adverse reaction to Wilfactin®

• Absence of functional defects of VWF measured between day 2 and day 4 after implantation (either PFA-ADP closure time >250 sec and or VWF:Act/VWF:Ag<0.7)

• Patient with a known thrombophilia

• Patient with a known severe bleeding disorder

• Patient refusal or environment

• Minor patients

• Pregnant women

Related Conditions & MeSH terms

• Heart Failure
• Hemorrhage

Intervention

Drug:
• Prophylactic treatment with Wilfactin
Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.

Locations

Country	Name	City	State
France	CHRU,	Lille

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Laboratoire français de Fractionnement et de Biotechnologies, Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (2)

Van Belle E, Rauch A, Vincentelli A, Jeanpierre E, Legendre P, Juthier F, Hurt C, Banfi C, Rousse N, Godier A, Caron C, Elkalioubie A, Corseaux D, Dupont A, Zawadzki C, Delhaye C, Mouquet F, Schurtz G, Deplanque D, Chinetti G, Staels B, Goudemand J, Jude B, Lenting PJ, Susen S. Von Willebrand factor as a biological sensor of blood flow to monitor percutaneous aortic valve interventions. Circ Res. 2015 Mar 27;116(7):1193-201. doi: 10.1161/CIRCRESAHA.116.305046. Epub 2015 Feb 10. — View Citation

Vincentelli A, Susen S, Le Tourneau T, Six I, Fabre O, Juthier F, Bauters A, Decoene C, Goudemand J, Prat A, Jude B. Acquired von Willebrand syndrome in aortic stenosis. N Engl J Med. 2003 Jul 24;349(4):343-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with clinically significant bleeding within 3 months after implantation	A clinically significant bleeding event is defined as internal or external bleeding leading to death or prolonged hospitalization or requiring re-hospitalization, surgery or transfusion of at least 3 units of packed red blood cells or hemoglobin drop> 3g/dL and/or refractory to conventional approach	3 months