NCT03306017

Brief Summary

To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

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

July 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2019

Completed
Last Updated

August 20, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

July 24, 2017

Last Update Submit

August 19, 2019

Conditions

Cardiac Insufficiency

Keywords

left ventricular assist deviceplatelet-leukocyte conjugateslipo-oxygenase products

Outcome Measures

Primary Outcomes (1)

  • Platelet activation

    To compare platelet activation in vivo, using a composite criteria determinated by variety of biomarkers of activation analysed by flow cytometry and enzyme-linked immunosorbent assay (ELISA)

    Month 2 after LAVD implantation

Secondary Outcomes (2)

  • Level of circulating platelet-leukocyte conjugate

    Month 2 after LAVD implantation

  • Changes in leukocyte phenotype

    Month 2 after LAVD implantation

Study Arms (1)

LAVD implantation

EXPERIMENTAL

Ten patients before and after LAVD implantation had blood sampling

Other: Blood sampling

Interventions

Blood samplingOTHER

Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.

LAVD implantation

Eligibility Criteria

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

You may qualify if:

  • elective implantation of LAVD (Heartmate II),
  • written informed consent to the study
  • Patients with health insurance

You may not qualify if:

  • treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed).
  • Pregnancy or breastfeeding
  • Juridical Protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Pierre SIE, MD, PhD

    University Hospital of Toulouse, Rangueil, Hematology laboratory

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2017

First Posted

October 10, 2017

Study Start

October 3, 2017

Primary Completion

August 23, 2018

Study Completion

January 23, 2019

Last Updated

August 20, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)