Extracorporeal Membrane Oxygenation ComplicationPhase 4ECSTATICNCT05796557
ECMO Hemostatic Transfusions in Children
A Phase 4 study testing Platelet Transfusion in people with Extracorporeal Membrane Oxygenation Complication and Hemorrhage, run by Yale University at 10 sites in 2 countries.
Trial summary
Critically ill children supported by extracorporeal membrane oxygenation (ECMO) receive large volumes of prophylactic platelet transfusions to prevent bleeding. However, mounting evidence has demonstrated significant morbidity and mortality associated with these transfusions. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Hemorrhage, Thromboembolism
- What is being tested?
- Platelet Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 12 Dec 2023to 25 Mar 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Critically ill children (0 to <18 years of age)
- Admitted to a participating pediatric, neonatal, or cardiac intensive care unite (PICU/NICU/CICU)
- On extracorporeal Membrane Oxygenation (ECMO)
- Who have either no bleeding or minimal bleeding, within 24 hours of cannulation. Minimal bleeding is defined as:
- streaks of blood in endotracheal tube or during suctioning only
- streaks of blood in nasogastric tube
Show all 10Show fewer
- macroscopic hematuria
- subcutaneous bleeding (including hematoma and petechiae) < 5 cm in diameter
- quantifiable bleeding < 1mL/kg/hr (e.g., chest tube)
- bloody dressings required to be changed no more often than each 6hr, or weighing no more than 1mL/kg/hr if weighed, due to slow saturation
Who cannot join
- Post-conception age < 37 weeks at time of screening
- Underlying oncologic diagnosis (defined as receipt of chemotherapy or radiation in the last six months) or recipient of bone marrow transplant in the last year
- Congenital bleeding disorder
- Pregnant or admitted post-partum
- Decision to withdraw or withhold some critical care or interventions
- Known objection to blood transfusions
- On ECMO for > 24 hours at time of enrollment
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Children's Healthcare of Atlanta - Emory
Atlanta, Georgia, 30322
Duke University School of Medicine
Durham, North Carolina, 27710
University of Iowa Health Care
Iowa City, Iowa, 52242
Norton Children's Hospital
Louisville, Kentucky, 40202
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Morgan Stanley Children's Hospital of New York Presbyterian
New York, New York, 10032
Komansky Children's Hospital of New York Presbyterian
New York, New York, 10065
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23219
Golisano Children's Hospital
Rochester, New York, 14642
About this study
Critically ill children supported by extracorporeal membrane oxygenation (ECMO) receive large volumes of prophylactic platelet transfusions to prevent bleeding. However, mounting evidence has demonstrated significant morbidity and mortality associated with these transfusions. The ECmo hemoSTAtic Transfusions In Children (ECSTATIC) pilot trial will test two different platelet transfusion strategies, based on two different platelet counts thresholds, one high (higher platelet transfusion strategy) and one low (lower platelet transfusion strategy). The pilot will gather the necessary information to perform a full trial which will provide a better understanding of how to transfuse platelets to children supported by ECMO and reduce the associated morbidity.
Read the detailed description
Due to coagulopathy and thrombocytopenia induced by hemodilution and the extracorporeal circuit itself, children supported by extracorporeal membrane oxygenation (ECMO) are at significant risk of bleeding. In order to prevent bleeding, pediatric intensivists often prescribe prophylactic platelet transfusions. However, in observational studies, prophylactic platelet transfusions to children on ECMO have been independently associated with increased thrombosis, mortality, and paradoxically, increased bleeding. Guidelines to direct platelet transfusions in this patient population are limited by the lack of evidence and therefore based on expert opinion alone. Given the significant associated risks, it is crucial to provide evidence to guide clinicians.
The ECSTATIC pilot, a randomized controlled trial endorsed by BloodNet, PediECMO, the Extracorporeal Life Support Organization (ELSO), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), will be conducted in ten sites (9 in the US and 1 in Israel). The investigators will enroll an anticipated 50 consecutive critically ill children (0 to <18 years of age), admitted to a participating pediatric, neonatal, or cardiac intensive care unit (PICU/NICU/CICU), on ECMO, and who have either no bleeding or minimal bleeding.
Non-bleeding children 0 to less than 18 years of age will be randomized 1:1 to either a platelet transfusion threshold of 90 x10e9/L (higher platelet transfusion strategy) or 50 x10e9/L (lower platelet transfusion strategy). Participants will be followed until progression to severe bleeding and/or severe thrombosis, decannulation from ECMO, or reach 21 days.
In this pilot, the investigators will test the separation between the lower and higher transfusion strategies. The primary outcomes will be the separation between pre-transfusion platelet counts, and the total platelet dose (in mL/kg/run). Secondary outcomes will be feasibility of patient enrollment and ability for an adjudication committee to determine the severity of bleeding and thrombotic outcomes.
The purpose of this pilot study is to determine the feasibility of the transfusion strategies, intervention parameters, subject availability, and other information regarding outcomes that are essential to complete the design of a large randomized controlled trial.
The large future trial will evaluate the efficacy of the two transfusion strategies, in terms of progression to severe bleeding and/or severe thrombosis. To adequately calculate the sample size, the investigators need to know the difference between the pre-transfusion platelet counts, the screening and inclusion rates, the proportion of patients who are consented within the first 24 hours after cannulation, the proportion of transfusions that are compliant with each arm's strategy, and the number of temporary suspensions.
The proposed pilot trial is innovative in that it is focused on children supported by ECMO, a population in whom transfusion strategies have never been tested previously; it involves the largest separation between the two arms of any platelet transfusion trial conducted in the past; and it involves two newly developed definitions of bleeding and thrombosis particularly applicable to children supported by ECMO.
The pilot trial will provide necessary and sufficient information to proceed with the definitive ECSTATIC Randomized Controlled Trial (RCT) to evaluate the impact of a lower prophylactic platelet transfusion threshold on the clinical outcomes in children on ECMO. ECSTATIC has the potential to optimize efficacy, to reduce platelet transfusion exposure and to decrease mortality and morbidity of these extremely ill infants and children.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Hemorrhage, Thromboembolism, Transfusion Adverse Reaction
- Being tested
- Platelet Transfusion
- Keywords
- Platelet transfusion, ECMO, Bleeding, Clotting, Mortality
- Medical subject headings
- Hemorrhage, Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet TransfusionBiological
Participants will be transfused according to the assigned threshold for each group, with a transfusion dose of 10 mL/kg, up to one adult unit.
| Study group | Role | What they receive |
|---|---|---|
| Higher platelet transfusion strategy | Active comparator | Participants randomized to this arm will be transfused if the platelet count is < 90 x 10e9 cells/L. Receives: Biological: Platelet Transfusion |
| Lower platelet transfusion strategy | Experimental | Participants randomized to this arm will be transfused if the platelet count is < 50 x 10e9 cells/L. Receives: Biological: Platelet Transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Platelet Transfusion Dose
The total dose (in mL/kg/day) will be computed by the research team, by dividing the total platelet transfusion volume by the patient's weight at admission and the number of days of intervention.
Measured: up to day 21
Pre-transfusion Platelet Count
Pre-transfusion platelet count, during intervention
Measured: During intervention
Secondary outcomes (8)
Feasibility Assessed by the Screening Rate
Feasibility will be assessed by the number of eligible participants that were screened.
Measured: At screening
Feasibility Assessed by the Inclusion Rate
Feasibility will be assessed by the number of eligible participants that were enrolled.
Measured: At screening
Feasibility Assessed by the Number of Informed Consents Signed in the First 24 Hours Post Cannulation.
Feasibility will be assessed by the number of participants that sign consent within the first 24 hours after ECMO cannulation.
Measured: At screening
Compliance With Transfusion Thresholds
The proportion of transfusions that were given for platelet counts below the arm threshold will be computed to assess compliance.
Measured: up to Day 21
Participants With at Least One Temporary Suspension
The number of participants who required at least one temporary suspension during ECMO.
Measured: up to Day 21
Duration for Temporary Suspensions
The investigators will collect information on the duration of each suspension.
Measured: up to Day 21
Progression to Composite Outcome of Severe Bleeding and/or Severe Thrombotic Event
The investigators will collect the proportion of participants who progress to a composite outcome of severe bleeding and/or severe thrombosis. The outcome will be adjudicated by an external review committee, blinded to the allocation arm.
Measured: up to Day 21
Number of Participants Who Were Withdrawn and/or Lost to Follow-up
Number of patients who withdraw from the study and/or are lost to follow-up (i.e., withdraw and/or are missing 90-day mortality assessment)
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 posted3 Apr 2023
- Study start12 Dec 2023
- Primary completion2 Jan 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized in a 1:1 ratio to either arm. Subjects will be stratified by type of extracorporeal membrane oxygenation (ECMO) support (Veno-Arterial vs Veno-Venous), by site, and by age (≤28 days vs \>28 days).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, University of Utah, National Heart, Lung, and Blood Institute (NHLBI), Columbia University, Virginia Commonwealth University, University of Rochester, Children's Hospital and Health System Foundation, Wisconsin, Duke University, Johns Hopkins All Children's Hospital, University of Iowa, Emory University, Schneider Children's Medical Center, Israel
- Responsible party
- Sponsor
- Investigators
- Oliver Karam, MD, PhD, Principal investigator, Yale UniversityMarianne Nellis, MD, MS, Principal investigator, NewYork-Presbyterian / Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796557
- Sponsor's protocol ID
- 2000034604
- Other IDs
- 1R34HL159119-01A1
- Acronym
- ECSTATIC
- Status last verified
- May 2025
- First submitted
- 17 Mar 2023
- Last updated
- 31 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research will include data from 50 critically ill subjects who are on extracorporeal life support (ECMO) enrolled at ten participating sites. The final dataset will include demographic and medical information, as well as laboratory data. After the investigators' proposed research is complete, each participating site will destroy the key linking this data to protected health information (PHI). Thus, the data will then be completely de-identified. However, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics, considering the variety of rare conditions leading to ECMO.
Publications
Nellis ME, Barney BJ, Coles G, Cholette JM, Choudhury TA, Furlong-Dillard J, Ozment C, Bain J, Niebler RA, Chegondi M, Badheka A, Schiller O, Shostak E, Joashi U, Paden M, Alvey JS, Muszynski JA, Spinella PC, Tucci M, Lacroix J, Stanworth S, O'Neil ER, Pollak U, Bahr T, Kumar SR, Karam O; BloodNet and PediECMO; subgroups of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI). Platelet Transfusion Thresholds for Children Supported by Extracorporeal Membrane Oxygenation: The Extracorporeal Membrane Oxygenation Hemostatic Transfusions in Children (ECSTATIC) Feasibility Clinical Trial. Crit Care Med. 2026 Mar 1;54(3):410-421. doi: 10.1097/CCM.0000000000006995. Epub 2025 Dec 23.
PubMed 41432485
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECMO Hemostatic Transfusions in Children
- ClinicalTrials.gov ID
- NCT05796557
- Acronym / sponsor ID
- ECSTATIC / 2000034604
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Hemorrhage, Thromboembolism, Transfusion Adverse Reaction
- Keywords
- Platelet transfusion, ECMO, Bleeding, Clotting, Mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, University of Utah, National Heart, Lung, and Blood Institute (NHLBI), Columbia University, Virginia Commonwealth University, University of Rochester, Children's Hospital and Health System Foundation, Wisconsin, Duke University, Johns Hopkins All Children's Hospital, University of Iowa, Emory University, Schneider Children's Medical Center, Israel
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Posted 31 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Critically ill children supported by extracorporeal membrane oxygenation (ECMO) receive large volumes of prophylactic platelet transfusions to prevent bleeding. However, mounting evidence has demonstrated significant morbidity and mortality associated with these transfusions. The ECmo hemoSTAtic Transfusions In Children (ECSTATIC) pilot trial will test two different platelet transfusion strategies, based on two different platelet counts thresholds, one high (higher platelet transfusion strategy) and one low (lower platelet transfusion strategy). The pilot will gather the necessary information to perform a full trial which will provide a better understanding of how to transfuse platelets to children supported by ECMO and reduce the associated morbidity.
Detailed description
Due to coagulopathy and thrombocytopenia induced by hemodilution and the extracorporeal circuit itself, children supported by extracorporeal membrane oxygenation (ECMO) are at significant risk of bleeding. In order to prevent bleeding, pediatric intensivists often prescribe prophylactic platelet transfusions. However, in observational studies, prophylactic platelet transfusions to children on ECMO have been independently associated with increased thrombosis, mortality, and paradoxically, increased bleeding. Guidelines to direct platelet transfusions in this patient population are limited by the lack of evidence and therefore based on expert opinion alone. Given the significant associated risks, it is crucial to provide evidence to guide clinicians.
The ECSTATIC pilot, a randomized controlled trial endorsed by BloodNet, PediECMO, the Extracorporeal Life Support Organization (ELSO), and the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI), will be conducted in ten sites (9 in the US and 1 in Israel). The investigators will enroll an anticipated 50 consecutive critically ill children (0 to <18 years of age), admitted to a participating pediatric, neonatal, or cardiac intensive care unit (PICU/NICU/CICU), on ECMO, and who have either no bleeding or minimal bleeding.
Non-bleeding children 0 to less than 18 years of age will be randomized 1:1 to either a platelet transfusion threshold of 90 x10e9/L (higher platelet transfusion strategy) or 50 x10e9/L (lower platelet transfusion strategy). Participants will be followed until progression to severe bleeding and/or severe thrombosis, decannulation from ECMO, or reach 21 days.
In this pilot, the investigators will test the separation between the lower and higher transfusion strategies. The primary outcomes will be the separation between pre-transfusion platelet counts, and the total platelet dose (in mL/kg/run). Secondary outcomes will be feasibility of patient enrollment and ability for an adjudication committee to determine the severity of bleeding and thrombotic outcomes.
The purpose of this pilot study is to determine the feasibility of the transfusion strategies, intervention parameters, subject availability, and other information regarding outcomes that are essential to complete the design of a large randomized controlled trial.
The large future trial will evaluate the efficacy of the two transfusion strategies, in terms of progression to severe bleeding and/or severe thrombosis. To adequately calculate the sample size, the investigators need to know the difference between the pre-transfusion platelet counts, the screening and inclusion rates, the proportion of patients who are consented within the first 24 hours after cannulation, the proportion of transfusions that are compliant with each arm's strategy, and the number of temporary suspensions.
The proposed pilot trial is innovative in that it is focused on children supported by ECMO, a population in whom transfusion strategies have never been tested previously; it involves the largest separation between the two arms of any platelet transfusion trial conducted in the past; and it involves two newly developed definitions of bleeding and thrombosis particularly applicable to children supported by ECMO.
The pilot trial will provide necessary and sufficient information to proceed with the definitive ECSTATIC Randomized Controlled Trial (RCT) to evaluate the impact of a lower prophylactic platelet transfusion threshold on the clinical outcomes in children on ECMO. ECSTATIC has the potential to optimize efficacy, to reduce platelet transfusion exposure and to decrease mortality and morbidity of these extremely ill infants and children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized in a 1:1 ratio to either arm. Subjects will be stratified by type of extracorporeal membrane oxygenation (ECMO) support (Veno-Arterial vs Veno-Venous), by site, and by age (≤28 days vs >28 days).
| Arm | Type | Receives |
|---|---|---|
| Higher platelet transfusion strategy | Active comparator | Biological: Platelet TransfusionParticipants randomized to this arm will be transfused if the platelet count is < 90 x 10e9 cells/L. |
| Lower platelet transfusion strategy | Experimental | Biological: Platelet TransfusionParticipants randomized to this arm will be transfused if the platelet count is < 50 x 10e9 cells/L. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Critically ill children (0 to <18 years of age)
- Admitted to a participating pediatric, neonatal, or cardiac intensive care unite (PICU/NICU/CICU)
- On extracorporeal Membrane Oxygenation (ECMO)
- Who have either no bleeding or minimal bleeding, within 24 hours of cannulation. Minimal bleeding is defined as:
Key exclusion criteria (7 listed)
- Post-conception age < 37 weeks at time of screening
- Underlying oncologic diagnosis (defined as receipt of chemotherapy or radiation in the last six months) or recipient of bone marrow transplant in the last year
- Congenital bleeding disorder
- Pregnant or admitted post-partum
- Decision to withdraw or withhold some critical care or interventions
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 TransfusionParticipants will be transfused according to the assigned threshold for each group, with a transfusion dose of 10 mL/kg, up to one adult unit. | Biological | Higher platelet transfusion strategy, Lower platelet transfusion strategy |
Primary outcome
Total Platelet Transfusion Dose
Time frame: up to day 21
The total dose (in mL/kg/day) will be computed by the research team, by dividing the total platelet transfusion volume by the patient's weight at admission and the number of days of intervention.
Pre-transfusion Platelet Count
Time frame: During intervention
Pre-transfusion platelet count, during intervention
8 secondary outcomes
Feasibility Assessed by the Screening Rate
Time frame: At screening
Feasibility Assessed by the Inclusion Rate
Time frame: At screening
Feasibility Assessed by the Number of Informed Consents Signed in the First 24 Hours Post Cannulation.
Time frame: At screening
Compliance With Transfusion Thresholds
Time frame: up to Day 21
Participants With at Least One Temporary Suspension
Time frame: up to Day 21
Duration for Temporary Suspensions
Time frame: up to Day 21
Progression to Composite Outcome of Severe Bleeding and/or Severe Thrombotic Event
Time frame: up to Day 21
Number of Participants Who Were Withdrawn and/or Lost to Follow-up
Time frame: Up to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41432485Nellis ME, Barney BJ, Coles G, Cholette JM, Choudhury TA, Furlong-Dillard J, Ozment C, Bain J, Niebler RA, Chegondi M, Badheka A, Schiller O, Shostak E, Joashi U, Paden M, Alvey JS, Muszynski JA, Spinella PC, Tucci M, Lacroix J, Stanworth S, O'Neil ER, Pollak U, Bahr T, Kumar SR, Karam O; BloodNet and PediECMO; subgroups of the Pediatric Acute Lung Injury and Sepsis Investigators (PALISI). Platelet Transfusion Thresholds for Children Supported by Extracorporeal Membrane Oxygenation: The Extracorporeal Membrane Oxygenation Hemostatic Transfusions in Children (ECSTATIC) Feasibility Clinical Trial. Crit Care Med. 2026 Mar 1;54(3):410-421. doi: 10.1097/CCM.0000000000006995. Epub 2025 Dec 23.
- Individual participant dataSharing planned: Yes. The proposed research will include data from 50 critically ill subjects who are on extracorporeal life support (ECMO) enrolled at ten participating sites. The final dataset will include demographic and medical information, as well as laboratory data. After the investigators' proposed research is complete, each participating site will destroy the key linking this data to protected health information (PHI). Thus, the data will then be completely de-identified. However, the investigators believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics, considering the variety of rare conditions leading to ECMO.
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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. This study is not recruiting at the moment.
Oliver Karam, MD, PhD principal investigator
Yale University
Marianne Nellis, MD, MS principal investigator
NewYork-Presbyterian / Weill Cornell
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet Transfusion in people with Extracorporeal Membrane Oxygenation Complication and Hemorrhage, run by Yale University at 10 sites in 2 countries.
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 10 inclusion and 7 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: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Platelet Transfusion Dose (time frame: up to day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796557, which also lists 1 linked publication.
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 31 May 2025.