ThrombocytopeniaPLATOMIRNCT07682246
EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT
An observational study of Thrombocytopenia and Prophylactic Platelet Transfusion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia, Prophylactic Platelet Transfusion, Platelet Transfusion
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any adult admitted to intensive care, regardless of the reason, who has thrombocytopenia and requires prophylactic platelet transfusion
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Medical Intensive Care Unit, Saint-Antoine Hospital, AP-HP, Paris, France
Paris, 75012
Hafid AIT-OUFELLA, Pr, 01 49 28 23 15 ext. +33, hafid.aitoufella@aphp.fr
About this study
Official title: EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT.
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.
Read the detailed description
This is a single-centre, non-randomised, non-interventional human research study (RIPH3) investigating the impact of platelet transfusion on endothelial function, endothelial biomarkers, systemic inflammation, oxidative stress and peripheral tissue perfusion. Patients will be recruited during their stay in intensive care, after receiving information and providing their consent (non opposition). Platelet transfusion will be prescribed as part of their treatment. Before the transfusion, at the end of the transfusion and one hour afterwards, a clinical examination will be performed, along with an assessment of tissue perfusion and microcirculatory blood flow measurements using a Doppler laser coupled with iontophoresis. Blood samples will be taken before the transfusion and one hour after its completion to assess the systemic inflammatory response. Participation in this research study will take a maximum of four hours. No specific follow-up is planned for patients included in the study.
- Conditions
- Thrombocytopenia, Prophylactic Platelet Transfusion, Platelet Transfusion, Endothelial Function
- Keywords
- ICU, intensive care, Platelet Transfusion, Endothelial Function, endothelial biomarkers, systemic inflammation, oxidative stress, peripheral tissue perfusion
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transfusion | Patients with thrombocytopenia who are admitted to intensive care for any reason and require prophylactic platelet transfusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before transfusion, right after transfusion and 1 hour after transfusion
Secondary outcomes (7)
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.
Measured: before transfusion and 1 hour after transfusion
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.
Measured: before transfusion and 1 hour after transfusion
Oxidative stress
Oxidative stress will be assessed by mass spectrometry.
Measured: before transfusion and 1 hour after transfusion
Peripheral tissue perfusion
Peripheral tissue perfusion will be assessed by measuring skin recolouration time
Measured: before transfusion, right after transfusion and 1 hour after transfusion
Peripheral tissue perfusion
Peripheral tissue perfusion will be assessed using a marbling score
Measured: before transfusion, right after transfusion and 1 hour after transfusion
Skin blood flow
Peripheral tissue perfusion will be assessed by measuring skin blood flow in the index finger using a skin Doppler sensor.
Measured: before transfusion, right after transfusion and 1 hour after transfusion
Urine output
Peripheral tissue perfusion will be assessed by measuring urine output.
Measured: before transfusion, right after transfusion and 1 hour after transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafid AIT-OUFELLA, Pr, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682246
- Sponsor's protocol ID
- APHP260009
- Other IDs
- IDRCB 2026-A00031-50
- Acronym
- PLATOMIR
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF PLATELET CONCENTRATE TRANSFUSION ON MICROCIRCULATORY ENDOTHELIAL FUNCTION IN INTENSIVE CARE UNIT.
- ClinicalTrials.gov ID
- NCT07682246
- Acronym / sponsor ID
- PLATOMIR / APHP260009
- Conditions
- Thrombocytopenia, Prophylactic Platelet Transfusion, Platelet Transfusion, Endothelial Function
- Keywords
- ICU, intensive care, Platelet Transfusion, Endothelial Function, endothelial biomarkers, systemic inflammation, oxidative stress, peripheral tissue perfusion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-centre, non-randomised, non-interventional human research study (RIPH3) investigating the impact of platelet transfusion on endothelial function, endothelial biomarkers, systemic inflammation, oxidative stress and peripheral tissue perfusion. Patients will be recruited during their stay in intensive care, after receiving information and providing their consent (non opposition). Platelet transfusion will be prescribed as part of their treatment. Before the transfusion, at the end of the transfusion and one hour afterwards, a clinical examination will be performed, along with an assessment of tissue perfusion and microcirculatory blood flow measurements using a Doppler laser coupled with iontophoresis. Blood samples will be taken before the transfusion and one hour after its completion to assess the systemic inflammatory response. Participation in this research study will take a maximum of four hours. No specific follow-up is planned for patients included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfusion | – | –Patients with thrombocytopenia who are admitted to intensive care for any reason and require prophylactic platelet transfusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any adult admitted to intensive care, regardless of the reason, who has thrombocytopenia and requires prophylactic platelet transfusion
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: before transfusion, right after transfusion and 1 hour after transfusion
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.
7 secondary outcomes
Endothelial biomarker levels
Time frame: before transfusion and 1 hour after transfusion
Systemic inflammatory biomarker levels
Time frame: before transfusion and 1 hour after transfusion
Oxidative stress
Time frame: before transfusion and 1 hour after transfusion
Peripheral tissue perfusion
Time frame: before transfusion, right after transfusion and 1 hour after transfusion
Peripheral tissue perfusion
Time frame: before transfusion, right after transfusion and 1 hour after transfusion
Skin blood flow
Time frame: before transfusion, right after transfusion and 1 hour after transfusion
Urine output
Time frame: before transfusion, right after transfusion and 1 hour after transfusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hafid AIT-OUFELLA, Pr principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia and Prophylactic Platelet Transfusion, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafid AIT-OUFELLA, Pr (01 49 28 23 15 ext. +33, hafid.aitoufella@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: before transfusion, right after transfusion and 1 hour after transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.