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NCT Number: NCT06599385

Platelet Transfusion in Critically Ill Patients With Thrombocytopenia

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.

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Key information

Conditions

Thrombocythemia Blood Platelet Disorders Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Platelet transfusion if platelet count ≤ 10 G/L

Other

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

Platelet transfusion when platelet count ≤ 20 G/L

Other

Platelet transfusion will be initiated immediately after randomisation

Primary outcomes

  1. Incidence of ICU-acquired severe and debilitating bleeding

    Time frame: Until ICU discharge or up to 28 days in ICU

    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).

Secondary outcomes

  1. Incidence of ICU-acquired mild bleeding

    Time frame: Until ICU discharge or at 28 days in ICU

    WHO grade 2

  2. Incidence of ICU-acquired mild to debilitating bleeding

    Time frame: Until ICU discharge or up to 28 days in ICU

    WHO grade 2-3-4

  3. Total number of platelet transfusions episodes

    Time frame: Until ICU discharge or up to 28 days in ICU

  4. Number of prophylactic platelet transfusions episodes

    Time frame: Until ICU discharge or up to 28 days in ICU

  5. Doses of transfused platelets

    Time frame: Until ICU discharge or up to 28 days in ICU

  6. Number of packed red cell transfusions

    Time frame: Until ICU discharge or up to 28 days in ICU

  7. Volumes of packed red cell transfusions

    Time frame: Until ICU discharge or up to 28 days in ICU

  8. Volumes of fresh frozen plasma

    Time frame: Until ICU discharge or up to 28 days in ICU

  9. Incidence of ICU-acquired infections

    Time frame: Up to 72 hours after ICU discharge

  10. Incidence of acquired arterial thrombotic events

    Time frame: Up to 72 hours after ICU discharge

    Acute coronary syndrome, acute limb ischemia, mesenteric ischemia, stroke

  11. Incidence of acquired venous thrombotic events

    Time frame: Up to 72 hours after ICU discharge

    Thrombophlebitis and pulmonary embolism

  12. Incidence of Central Venous Catheter (CVC)-related hemorrhagic and infectious complications

    Time frame: Up to 72 hours after ICU discharge

  13. Incidence of platelet transfusion-related side effects

    Time frame: Up to 72 hours after ICU discharge

    Any significant transfusion reaction such as chills and fever or side effect requiring to be reported to the local hemovigilance system

  14. Incidence of transfusion-related pulmonary manifestations (acute pulmonary oedema and acute lung injury (TRALI))

    Time frame: Up to 72 hours after ICU discharge

  15. Incidence of anti-HLA/HPA immunization

    Time frame: Up to 72 hours after ICU discharge

    Investigated in case of platelet transfusion refractoriness

  16. In ICU survival

    Time frame: Up to 90 days

    Investigated in case of platelet transfusion refractoriness

  17. In hospital survival

    Time frame: Up to 90 days

    Investigated in case of platelet transfusion refractoriness

  18. 28 day survival

    Time frame: At 28 days

    Investigated in case of platelet transfusion refractoriness

  19. In ICU length of stay

    Time frame: Up to 90 days

  20. In hospital length of stay

    Time frame: Up to 90 days

  21. 90-day survival

    Time frame: Up to 90 days

  22. 90-day hospital costs

    Time frame: Up to 90 days

    From randomization to day 90

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric Pene, MD PhD

CONTACT

[email protected]

0158414677 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

0142499742 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: TRAMPOLINE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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