NCT07682246

Brief Summary

This study aims to investigate the impact of platelet concentrate (PC) transfusions on endothelial function and the systemic inflammatory response in thrombopenic patients admitted to intensive care who require prophylactic platelet transfusions. Endothelial function will be measured using a laser Doppler device coupled with an acetylcholine iontophoresis system that is applied to the skin.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
11mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress9%
Jul 2026Jul 2027

First Submitted

Initial submission to the registry

June 19, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 2, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 19, 2026

Last Update Submit

June 26, 2026

Conditions

Keywords

ICUintensive carePlatelet TransfusionEndothelial Functionendothelial biomarkerssystemic inflammationoxidative stressperipheral tissue perfusion

Outcome Measures

Primary Outcomes (1)

  • Assessing the effects of platelet transfusion on endothelial function in the microcirculation. Endothelial function will be measured using a Doppler laser coupled with an acetylcholine iontophoresis system applied to the skin.

    The area under the microcirculatory blood flow curve is measured over 10 minutes using a cutaneous laser Doppler sensor coupled with iontophoresis (Périmed, France). The data is analysed using computer software connected to the Doppler device.

    before transfusion, right after transfusion and 1 hour after transfusion

Secondary Outcomes (7)

  • Endothelial biomarker levels

    before transfusion and 1 hour after transfusion

  • Systemic inflammatory biomarker levels

    before transfusion and 1 hour after transfusion

  • Oxidative stress

    before transfusion and 1 hour after transfusion

  • Peripheral tissue perfusion

    before transfusion, right after transfusion and 1 hour after transfusion

  • Peripheral tissue perfusion

    before transfusion, right after transfusion and 1 hour after transfusion

  • +2 more secondary outcomes

Study Arms (1)

Transfusion

Patients with thrombocytopenia who are admitted to intensive care for any reason and require prophylactic platelet transfusion.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any adult admitted to intensive care, regardless of the reason, who has thrombocytopenia and requires prophylactic platelet transfusion

You may qualify if:

  • Adult patient ≥ 18 years of age
  • Admitted to intensive care
  • Requires prophylactic platelet transfusion for thrombocytopenia
  • Enrolled in a social security program
  • No objection to participating in the study

You may not qualify if:

  • Recent platelet or red blood cell transfusion (\< 24 hours)
  • Need for urgent red blood cell transfusion due to active bleeding
  • Patient under guardianship or conservatorship
  • Significant peripheral edema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Intensive Care Unit, Saint-Antoine Hospital, AP-HP, Paris, France

Paris, 75012, France

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Hafid AIT-OUFELLA, Pr

    APHP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafid AIT-OUFELLA, Pr

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 19, 2026

First Posted

July 2, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Last Updated

July 2, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations