Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

NCT ID: NCT06599385

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2028-02-01

Brief Summary

Thrombocytopenia is a common biological disorder in critically ill patients. The main supportive treatment is platelet transfusion with the aim of preventing and treating bleeding and securing invasive procedures. Current guidelines suggest that prophylactic platelet transfusion should probably be administered in non-bleeding critically ill patients at platelet count triggers of 10 to 20 G/L, albeit with very low certainty since extrapolated from studies carried out in stable patients with hematological malignancies. Indications for prophylactic platelet transfusion have not been properly addressed in adult ICU patients with regard to their particular risk of bleeding and prognosis. We propose the TRAMPOLINE study in order to address two different platelet count thresholds of 10 G/L (low threshold) or 20 G/L (high threshold) for the prevention of ICU-acquired bleeding in critically ill patients with severe thrombocytopenia.

Conditions

Thrombocythemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Low-threshold

Group Type: ACTIVE_COMPARATOR

Platelet transfusion if platelet count ≤ 10 G/L

Intervention Type: OTHER

Platelet transfusion as soon as platelet count falls ≤ 10 G/L

High threshold

Group Type: EXPERIMENTAL

Platelet transfusion when platelet count ≤ 20 G/L

Intervention Type: OTHER

Platelet transfusion will be initiated immediately after randomisation

Interventions

Platelet transfusion if platelet count ≤ 10 G/L

Platelet transfusion as soon as platelet count falls ≤ 10 G/L

Intervention Type: OTHER

Platelet transfusion when platelet count ≤ 20 G/L

Platelet transfusion will be initiated immediately after randomisation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 y.o. AND

2. Hospitalisation in the ICU with at least one of the following life support during the current ICU stay (past or ongoing, regardless of indications)

• circulatory support (inotropes/ vasopressors at any dose)
• respiratory support (invasive mechanical ventilation, non-invasive ventilation, continuous positive airway pressure (CPAP), high-flow nasal oxygen, O2 supply ≥ 6 L/min)
• renal replacement therapy for metabolic disturbances and/or acute and acute-on chronic kidney failure (if not previously under chronic hemodialysis) AND

3. Platelet count ≤ 20 G/L within the last 24h (first occurrence at any time during the ICU stay) AND

4. expected ICU stay for at least 48 hours from the time of enrollment AND

5. Signed consent by the patient or his/her relative, or under an emergency procedure (emergency enrollment notified in the medical file, with requirement for confirmation consent a posteriori)

Exclusion Criteria

1. Major bleeding (WHO grade 3-4) or mild bleeding (WHO grade 2) within the present hospitalization

2. Major surgery within the recent 72 hours

3. Intracranial or retinal bleeding within the recent 7 days

4. Non- or contra-indication to prophylactic platelet transfusion (immune thrombocytopenia, thrombotic microangiopathy)

5. Indications for increased prophylactic platelet transfusion threshold > 20 G/L (conditions associated with increased risk of bleeding including, but not limited to extra-corporeal membrane oxygenation, therapeutic anticoagulant treatment, fibrinolysis…)

6. Known full refractory status to platelet transfusion (prophylactic transfusion not recommended)

7. Prophylactic platelet transfusion already applied at platelet count ≤ 20 G/L during the present ICU stay

8. Patient opposed to transfusion of blood products

9. Moribund patients (death expected within the next 24 hours)

10. Pregnancy/breastfeeding

11. Not covered by French Social Security (health insurance)

12. Patient under safeguarding of justice

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Frédéric Pene, MD PhD

Role: CONTACT

frederic.pene@aphp.fr

0158414677 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

0142499742 ext. +33

Other Identifiers

APHP230835

Identifier Type: -

Identifier Source: org_study_id