ThrombocythemiaPhase 3TRAMPOLINENCT06599385
Platelet Transfusion in Critically Ill Patients With Thrombocytopenia
A Phase 3 study testing Platelet transfusion if platelet count ≤ 10 G/L and Platelet transfusion when platelet count ≤ 20 G/L in people with Thrombocythemia, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocythemia
- What is being tested?
- Platelet transfusion if platelet count ≤ 10 G/L and Platelet transfusion when platelet count ≤ 20 G/L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Feb 2028
- Phase
- Phase 3
- 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
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Platelet transfusion if platelet count ≤ 10 G/L, Platelet transfusion when platelet count ≤ 20 G/L
- Keywords
- Platelet transfusion, Thrombocythemia
- Medical subject headings
- Thrombocytosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet transfusion if platelet count ≤ 10 G/LOther
Platelet transfusion as soon as platelet count falls ≤ 10 G/L
Platelet transfusion when platelet count ≤ 20 G/LOther
Platelet transfusion will be initiated immediately after randomisation
| Study group | Role | What they receive |
|---|---|---|
| Low-threshold | Active comparator | Not described Receives: Other: Platelet transfusion if platelet count ≤ 10 G/L |
| High threshold | Experimental | Not described Receives: Other: Platelet transfusion when platelet count ≤ 20 G/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Until ICU discharge or up to 28 days in ICU
Secondary outcomes (22)
Incidence of ICU-acquired mild bleeding
WHO grade 2
Measured: Until ICU discharge or at 28 days in ICU
Incidence of ICU-acquired mild to debilitating bleeding
WHO grade 2-3-4
Measured: Until ICU discharge or up to 28 days in ICU
Total number of platelet transfusions episodes
Measured: Until ICU discharge or up to 28 days in ICU
Number of prophylactic platelet transfusions episodes
Measured: Until ICU discharge or up to 28 days in ICU
Doses of transfused platelets
Measured: Until ICU discharge or up to 28 days in ICU
Number of packed red cell transfusions
Measured: Until ICU discharge or up to 28 days in ICU
Volumes of packed red cell transfusions
Measured: Until ICU discharge or up to 28 days in ICU
Volumes of fresh frozen plasma
Measured: Until ICU discharge or up to 28 days in ICU
Incidence of ICU-acquired infections
Measured: Up to 72 hours after ICU discharge
Incidence of acquired arterial thrombotic events
Acute coronary syndrome, acute limb ischemia, mesenteric ischemia, stroke
Measured: Up to 72 hours after ICU discharge
Incidence of acquired venous thrombotic events
Thrombophlebitis and pulmonary embolism
Measured: Up to 72 hours after ICU discharge
Incidence of Central Venous Catheter (CVC)-related hemorrhagic and infectious complications
Measured: Up to 72 hours after ICU discharge
Incidence of platelet transfusion-related side effects
Any significant transfusion reaction such as chills and fever or side effect requiring to be reported to the local hemovigilance system
Measured: Up to 72 hours after ICU discharge
Incidence of transfusion-related pulmonary manifestations (acute pulmonary oedema and acute lung injury (TRALI))
Measured: Up to 72 hours after ICU discharge
Incidence of anti-HLA/HPA immunization
Investigated in case of platelet transfusion refractoriness
Measured: Up to 72 hours after ICU discharge
In ICU survival
Investigated in case of platelet transfusion refractoriness
Measured: Up to 90 days
In hospital survival
Investigated in case of platelet transfusion refractoriness
Measured: Up to 90 days
28 day survival
Investigated in case of platelet transfusion refractoriness
Measured: At 28 days
In ICU length of stay
Measured: Up to 90 days
In hospital length of stay
Measured: Up to 90 days
90-day survival
Measured: Up to 90 days
90-day hospital costs
From randomization to day 90
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocythemiaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective non-inferiority open-label randomised trial with two comparative groups
- Masking
- None (open label)
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599385
- Sponsor's protocol ID
- APHP230835
- Acronym
- TRAMPOLINE
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Transfusion in Critically Ill Patients With Thrombocytopenia
- ClinicalTrials.gov ID
- NCT06599385
- Acronym / sponsor ID
- TRAMPOLINE / APHP230835
- Conditions
- Thrombocythemia
- Keywords
- Platelet transfusion, Thrombocythemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective non-inferiority open-label randomised trial with two comparative groups
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
- 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)
Key exclusion criteria (12 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet transfusion if platelet count ≤ 10 G/LPlatelet transfusion as soon as platelet count falls ≤ 10 G/L | Other | Low-threshold |
| Platelet transfusion when platelet count ≤ 20 G/LPlatelet transfusion will be initiated immediately after randomisation | Other | High threshold |
Primary outcome
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).
22 secondary outcomes
Incidence of ICU-acquired mild bleeding
Time frame: Until ICU discharge or at 28 days in ICU
Incidence of ICU-acquired mild to debilitating bleeding
Time frame: Until ICU discharge or up to 28 days in ICU
Total number of platelet transfusions episodes
Time frame: Until ICU discharge or up to 28 days in ICU
Number of prophylactic platelet transfusions episodes
Time frame: Until ICU discharge or up to 28 days in ICU
Doses of transfused platelets
Time frame: Until ICU discharge or up to 28 days in ICU
Number of packed red cell transfusions
Time frame: Until ICU discharge or up to 28 days in ICU
Volumes of packed red cell transfusions
Time frame: Until ICU discharge or up to 28 days in ICU
Volumes of fresh frozen plasma
Time frame: Until ICU discharge or up to 28 days in ICU
Incidence of ICU-acquired infections
Time frame: Up to 72 hours after ICU discharge
Incidence of acquired arterial thrombotic events
Time frame: Up to 72 hours after ICU discharge
Incidence of acquired venous thrombotic events
Time frame: Up to 72 hours after ICU discharge
Incidence of Central Venous Catheter (CVC)-related hemorrhagic and infectious complications
Time frame: Up to 72 hours after ICU discharge
Incidence of platelet transfusion-related side effects
Time frame: Up to 72 hours after ICU discharge
Incidence of transfusion-related pulmonary manifestations (acute pulmonary oedema and acute lung injury (TRALI))
Time frame: Up to 72 hours after ICU discharge
Incidence of anti-HLA/HPA immunization
Time frame: Up to 72 hours after ICU discharge
In ICU survival
Time frame: Up to 90 days
In hospital survival
Time frame: Up to 90 days
28 day survival
Time frame: At 28 days
In ICU length of stay
Time frame: Up to 90 days
In hospital length of stay
Time frame: Up to 90 days
90-day survival
Time frame: Up to 90 days
90-day hospital costs
Time frame: Up to 90 days
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Platelet transfusion if platelet count ≤ 10 G/L and Platelet transfusion when platelet count ≤ 20 G/L in people with Thrombocythemia, run by Assistance Publique - Hôpitaux de Paris.
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 8 inclusion and 12 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Frédéric Pene, MD PhD (0158414677 ext. +33, frederic.pene@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ICU-acquired severe and debilitating bleeding (time frame: Until ICU discharge or up to 28 days in ICU). 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 19 Sep 2024.