EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient ≥ 18 years of age

Admitted to intensive care

Requires prophylactic platelet transfusion for thrombocytopenia

Enrolled in a social security program

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Transfusion

Trial outcomes

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.

Time frame
before transfusion, right after transfusion and 1 hour after transfusion

Secondary outcomes

1

Endothelial biomarker levels

Endothelial response will be assessed by measuring circulating levels of syndecan-1, hyaluronic acid, ICAM-1, VCAM-1, E-selectin, endothelial protein C receptor (EPCR), and von Willebrand factor.

Time frame
before transfusion and 1 hour after transfusion
2

Systemic inflammatory biomarker levels

Systemic inflammation will be assessed by measuring C-reactive protein (CRP), leukocyte count, interleukin (IL)-1β, IL-6, tumor necrosis factor-α (TNF-α), IL-10, CCL2, CCL5, CXCL1, and circulating microparticles.

Time frame
before transfusion and 1 hour after transfusion
3

Oxidative stress

Oxidative stress will be assessed by mass spectrometry.

Time frame
before transfusion and 1 hour after transfusion
4

Peripheral tissue perfusion

Peripheral tissue perfusion will be assessed by measuring skin recolouration time

Time frame
before transfusion, right after transfusion and 1 hour after transfusion

Other outcomes

Sponsors and contacts

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