Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

NCT06599385 | Not Yet Recruiting Phase 3

• 1 other identifier: APHP230835
• Study Type: interventional
• Target: 536
• Locations: 0 countries
• Sites: N/A

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

Keywords

Platelet transfusion; Thrombocythemia

Outcome Measures

Primary Outcomes (1)

• Incidence of ICU-acquired severe and debilitating bleeding

  Grades 3-4 of the modified WHO bleeding scale, assessed during the ICU stay, from the time of randomization to ICU discharge (or to the end of 28-day intervention period in patients remaining in the ICU after 28 days). Bleeding events will be collected up to 72h after ICU discharge. The modified WHO bleeding scale, commonly used in observational studies and trials to assess the severity of bleeding. It comprises 4 grades: grade 1 (minor blood loss), grade 2 (mild blood loss), grade 3 (severe blood loss (most often requiring Red Blood Cell transfusion) and grade 4 (debilitating blood loss).

  Until ICU discharge or up to 28 days in ICU

Secondary Outcomes (22)

• Incidence of ICU-acquired mild bleeding

  Until ICU discharge or at 28 days in ICU

• Incidence of ICU-acquired mild to debilitating bleeding

  Until ICU discharge or up to 28 days in ICU

• Total number of platelet transfusions episodes

  Until ICU discharge or up to 28 days in ICU

• Number of prophylactic platelet transfusions episodes

  Until ICU discharge or up to 28 days in ICU

• Doses of transfused platelets

  Until ICU discharge or up to 28 days in ICU

Study Arms (2)

Low-threshold

ACTIVE COMPARATOR

Other: Platelet transfusion if platelet count ≤ 10 G/L

High threshold

EXPERIMENTAL

Other: Platelet transfusion when platelet count ≤ 20 G/L

Interventions

Platelet transfusion if platelet count ≤ 10 G/L OTHER

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

Low-threshold

Platelet transfusion when platelet count ≤ 20 G/L OTHER

Platelet transfusion will be initiated immediately after randomisation

High threshold

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 y.o. AND
• 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
• Platelet count ≤ 20 G/L within the last 24h (first occurrence at any time during the ICU stay) AND
• expected ICU stay for at least 48 hours from the time of enrollment AND
• 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)

You may not qualify if:

• Major bleeding (WHO grade 3-4) or mild bleeding (WHO grade 2) within the present hospitalization
• Major surgery within the recent 72 hours
• Intracranial or retinal bleeding within the recent 7 days
• Non- or contra-indication to prophylactic platelet transfusion (immune thrombocytopenia, thrombotic microangiopathy)
• 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…)
• Known full refractory status to platelet transfusion (prophylactic transfusion not recommended)
• Prophylactic platelet transfusion already applied at platelet count ≤ 20 G/L during the present ICU stay
• Patient opposed to transfusion of blood products
• Moribund patients (death expected within the next 24 hours)
• Pregnancy/breastfeeding
• Not covered by French Social Security (health insurance)
• Patient under safeguarding of justice

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Thrombocytosis

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Myeloproliferative Disorders; Bone Marrow Diseases

Central Study Contacts

Frédéric Pene, MD PhD

CONTACT

0158414677; frederic.pene@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

0142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective non-inferiority open-label randomised trial with two comparative groups

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09