Study of Platelet Population Changes Under Circulatory Su... | NCT07334457

Studies
Study of Platelet Population Changes Under Circulatory Support With ECMO

NCT07334457

Sponsor

University Hospital, Strasbourg, France

Status

Recruiting

Last Update Posted

Jan 12, 2026Actual

Enrollment

75Estimated

Phase

Not provided

Conditions

Cardiac Failure
Respiratory Failure

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2025Actual

Primary Completion Date

Mar 2027Estimated

Completion Date

Mar 11, 2027Estimated

First Submitted Date

Dec 30, 2025

First Submission Date that Met QC Criteria

Dec 30, 2025

First Posted Date

Jan 12, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2025

Last Update Posted Date

Jan 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Advances in flow cytometry techniques have led to a better understanding of platelet phenotypes and have revealed the existence of four major platelet populations with distinct functional properties (native, proaggregating, procoagulating, or apoptotic). These phenotypes have a significant impact on the hemostatic capacity of blood platelets, and a proportional change in these populations during ECMO treatment could, at least in part, contribute to the observed complications.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportional Changes in the Different Platelet Populations (native, proaggregating, procoagulant, or apoptotic)	Proportional Changes in the Different Platelet Populations (native, proaggregating, procoagulant, or apoptotic) on Days 1, 3, and 7 after the initiation of ECMO treatment.	Days 1, 3, and 7 after the initiation of ECMO treatment.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient (≥18 years) treated in one of the intensive care units of the Anesthesia and Intensive Care Department at Strasbourg University Hospital.
Implanted with veno-arterial or veno-venous ECMO within the previous 24 hours.

Exclusion Criteria:

Subject who has expressed their opposition to participating in the study.
Subject under legal protection.
Subject under guardianship or curatorship.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

- Adult patient (≥18 years) treated in one of the intensive care units of the Anesthesia and Intensive Care Department at Strasbourg University Hospital and implanted with veno-arterial or veno-venous ECMO within the previous 24 hours.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Charles TACQUARD, MD, PhD	Contact	33.3.69.55.16.08		charlesambroise.tacquard@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'anesthésie-réanimation - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D012131	Respiratory Insufficiency

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided