Cardiopulmonary Bypass SurgeryPhase 4PEDITRECNCT05293106
Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
A Phase 4 study testing Platelet Transfusion in people with Cardiopulmonary Bypass Surgery, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling). Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiopulmonary Bypass Surgery
- What is being tested?
- Platelet Transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jul 2022to 27 Sep 2023
- 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
- Male or female 0 up to and including 18 years of age
- Undergoing elective cardiopulmonary bypass surgery
- Are planned to have a chest tube placed in the operating room prior to chest closure
Who cannot join
- >/=19 years of age
- Preterm infants (less than 38-week gestational age at time of surgery)
- On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
- Family requests limitation of blood products (i.e. Jehovah's Witness)
- Congenital bleeding disorder
- Are planned to require ECMO post-op
- Previously enrolled in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Morgan Stanley Children's Hospital at Columbia University
New York, New York, 10032
Komansky Children's Hospital at Weill Cornell
New York, New York, 10065
About this study
This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).
Read the detailed description
This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.
- Conditions
- Cardiopulmonary Bypass Surgery
- Being tested
- Platelet Transfusion
- Keywords
- Platelet Transfusion, LVDS platelet transfusion, PR platelet transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet TransfusionBiological
All platelet transfusions will be given as 10mL/kg as is considered standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Pathogen-reduced (PR) platelet transfusions | Active comparator | FDA approved and already used in this patient population Receives: Biological: Platelet Transfusion |
| Large volume delayed sampling - LVDS | Active comparator | FDA approved and already used in this patient population Receives: Biological: Platelet Transfusion |
| No platelet transfusion | No intervention | Subject will not receive a platelet transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery
Chest tube output for first 24 hours following cardiopulmonary bypass surgery
Measured: Within the first 24 hours post-op.
Secondary outcomes (4)
Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op
Total dose red blood cell volume transfused in first 48 hours post-op (includes both red blood cell as well as cellsaver)
Measured: During hospitalization in the first 48 hours (no follow-up visits necessary)
Total Platelet Volume Transfused in the First 48 Hours Post-op
Total platelet volume transfused in the first 48 hours post-op
Measured: During hospitalization in the first 48 hours (no follow-up visits necessary)
Total Plasma Volume Transfused in the First 48 Hours Post-op
Total plasma volume transfused in the first 48 hours post-op
Measured: During hospitalization in the first 48 hours (no follow-up visits necessary)
Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op.
Total cryoprecipitate volume transfused in the first 48 hours post-op.
Measured: During hospitalization in the first 48 hours (no follow-up visits necessary)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start5 Jul 2022
- Primary completion17 Sep 2023
- Study completion27 Sep 2023
Why it stopped: Difficulty recruiting and enrolling subjects.
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.
- Other trials for Cardiopulmonary Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marianne Nellis, MD, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293106
- Sponsor's protocol ID
- 21-11024115
- Acronym
- PEDITREC
- Status last verified
- Jul 2024
- First submitted
- 14 Mar 2022
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT05293106
- Acronym / sponsor ID
- PEDITREC / 21-11024115
- Conditions
- Cardiopulmonary Bypass Surgery
- Keywords
- Platelet Transfusion, LVDS platelet transfusion, PR platelet transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty recruiting and enrolling subjects.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 17 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 24 Mar 2022 (actual)
- Results
- Posted 20 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).
Detailed description
This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet transfusions both during and for 24 hours following cardiopulmonary bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pathogen-reduced (PR) platelet transfusions | Active comparator | Biological: Platelet TransfusionFDA approved and already used in this patient population |
| Large volume delayed sampling - LVDS | Active comparator | Biological: Platelet TransfusionFDA approved and already used in this patient population |
| No platelet transfusion | No intervention | –Subject will not receive a platelet transfusion |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male or female 0 up to and including 18 years of age
- Undergoing elective cardiopulmonary bypass surgery
- Are planned to have a chest tube placed in the operating room prior to chest closure
Key exclusion criteria (7 listed)
- >/=19 years of age
- Preterm infants (less than 38-week gestational age at time of surgery)
- On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
- Family requests limitation of blood products (i.e. Jehovah's Witness)
- Congenital bleeding disorder
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 TransfusionAll platelet transfusions will be given as 10mL/kg as is considered standard of care. | Biological | Large volume delayed sampling - LVDS, Pathogen-reduced (PR) platelet transfusions |
Primary outcome
Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery
Time frame: Within the first 24 hours post-op.
Chest tube output for first 24 hours following cardiopulmonary bypass surgery
4 secondary outcomes
Total Dose Red Blood Cell Volume Transfused in First 48 Hours Post-op
Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)
Total Platelet Volume Transfused in the First 48 Hours Post-op
Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)
Total Plasma Volume Transfused in the First 48 Hours Post-op
Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)
Total Cryoprecipitate Volume Transfused in the First 48 Hours Post-op.
Time frame: During hospitalization in the first 48 hours (no follow-up visits necessary)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Marianne Nellis, MD, MS principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: 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 Cardiopulmonary Bypass Surgery, run by Weill Medical College of Cornell University at 2 sites in United States.
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 3 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: stopped early, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 20 Aug 2024). 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?
Post-operative Bleeding Measured by Chest Tube Output for First 24 Hours Following Cardiopulmonary Bypass Surgery (time frame: Within the first 24 hours post-op.). 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 20 Aug 2024.