Platelets and Extracorporeal Membrane Oxygenation Veno-venous

NCT07580469 | Not Yet Recruiting

• 1 other identifier: RC31/25/0617
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In severe lung or heart disease, ExtraCorporeal Membrane Oxygenation (ECMO) may be used temporarily and can be responsible for major haemorrhagic complications. Thrombocytopenia and possibly thrombopathy promote bleeding. The primary objective is to characterize platelet dysfunction by aggregometry tests over time. Secondarily, investigators seek a correlation between haemorrhagic complications at day 10 and markers of platelet action and dysfunction; also, with the level of anticoagulation and inflammation by biomarkers.

Conditions

Extracorporeal Membrane Oxygenation Complication; Hemorrhage; Blood Platelet Disorder; Thrombosis

Keywords

VV-ECMO; Platelets; Thrombopathy; thrombo-haemorrhagic complications; thrombo-inflammation

Outcome Measures

Primary Outcomes (4)

• Platelet aggregation response over time during venovenous ECMO at baseline

  Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).

  T0: Baseline (before ECMO initiation)

• Platelet aggregation response over time during venovenous ECMO at Day 2 of ECMO

  Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).

  T1: Day 2 of ECMO

• Platelet aggregation response over time during venovenous ECMO at Day 5 of ECMO

  Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).

  T2: Day 5 of ECMO

• Platelet aggregation response over time during venovenous ECMO at Day 8 of ECMO

  Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).

  T3: Day 8 of ECMO

Secondary Outcomes (11)

• Number of bleeding event

  Up to Day 10 of ECMO

• Platelet activation marker

  day 8

• Platelet aggregation intensity

  day 8

• Leukocyte-platelet aggregate percentage

  day 8

• Systemic anticoagulation level (anti-Xa activity)

  day 8

Study Arms (1)

patients on Extracorporeal Membrane Oxygenation veno-venous

major patients admitted to the general intensive care unit on Extracorporeal Membrane Oxygenation veno-venous

Other: blood draws

Interventions

blood draws OTHER

Part of the biology data is used from the patient's routine blood tests. Additional blood samples are taken from an arterial catheter already in place. They are performed over 4 periods: one just before start ECMO and 3 under ECMO at 3-day intervals

patients on Extracorporeal Membrane Oxygenation veno-venous

Eligibility Criteria

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

Study Population

The study population will be selected from adult patients requiring venovenous ECMO support and admitted to the general intensive care unit of Hôpital Rangueil (Toulouse University Hospital), a regional referral center for ECMO in Occitanie West. Patients may be transferred from other hospitals in the region or directly managed at Hôpital Rangueil following ECMO implantation.

You may qualify if:

• Adults aged ≥ 18 years
• Patients requiring admission to the general intensive care unit of Hôpital Rangueil for venovenous ECMO
• Equipped with an arterial catheter for blood sampling
• Ability to undergo the 4 blood draws relevant to the study
• Receiving therapeutic anticoagulation with unfractionated heparin
• Enrolled in a social security program or equivalent
• No measures for Limitation and Withdrawal of Therapy have been implemented

You may not qualify if:

• Minors
• Patients under court-appointed guardianship or conservatorship
• Pregnant or breastfeeding women
• Hematological disease (leukemia, lymphoma) or constitutional thrombocytopenia
• Platelet transfusion within 7 days prior to enrollment
• Indication for immediate emergency ECMO preventing blood sampling before placement
• Post-cardiotomy
• Patient on antiplatelet therapy
• Severe thrombocytopenia \<50 G/L
• Other invasive mechanical support such as Impella®, intra-aortic balloon pump, or Left Ventricular Assist Device (LVAD)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

platelet aggregation tests following stimulation with three thrombin receptor-activating peptides (TRAP), Collagen-Related Peptide (CRP), and Adenosine Diphosphate (ADP), and across the four sampling periods at T0 (prior to ECMO initiation), T1 (Day 2), T2 (Day 5), and T3 (Day 8) of ECMO-VV.

MeSH Terms

Conditions

Hemorrhage; Blood Platelet Disorders; Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Baptiste COMPAGNON

CONTACT

5 61 32 27 99; compagnon.b@chu-toulouse.fr

Study Design

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

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Locations

FR (1)