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Platelet Transfusion
Platelet Transfusion for Cardiopulmonary Bypass (PEDITREC Trial)
Phase 4
Recruiting
Led By Marianne Nellis, MD, MS
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female 0 up to and including 18 years of age
Are planned to have a chest tube placed in the operating room prior to chest closure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during hospitalization in the first 48 hours (no follow-up visits necessary)
Awards & highlights
PEDITREC Trial Summary
This trial is testing if pathogen-reduced platelets can control bleeding as well as non-pathogen-reduced platelets.
Who is the study for?
This trial is for children up to 18 years old who are scheduled for elective heart surgery with cardiopulmonary bypass and will have a chest tube placed. It's not for those over 18, on heart-lung support before surgery, born prematurely, with bleeding disorders, previously in the study, or whose family limits blood products.Check my eligibility
What is being tested?
The study examines if pathogen-reduced platelets can control bleeding during heart surgery as effectively as traditional platelets (large volume delayed sampling) in pediatric patients undergoing cardiopulmonary bypass.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks of platelet transfusion include allergic reactions, fever, infection risk increase due to weakened immune response from the transfused product.
PEDITREC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or younger.
Select...
I am scheduled to have a chest tube placed during surgery before my chest is closed.
Select...
I am scheduled for elective heart-lung machine surgery.
PEDITREC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during hospitalization in the first 48 hours (no follow-up visits necessary)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hospitalization in the first 48 hours (no follow-up visits necessary)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative bleeding as measured by chest tube output for first 24 hours following cardiopulmonary bypass surgery
Secondary outcome measures
Total cryoprecipitate volume transfused in the first 48 hours post-op.
Total dose red blood cell volume transfused in first 48 hours post-op
Total plasma volume transfused in the first 48 hours post-op
+1 morePEDITREC Trial Design
2Treatment groups
Active Control
Group I: Large volume delayed sampling - LVDSActive Control1 Intervention
FDA approved and already used in this patient population
Group II: Pathogen-reduced (PR) platelet transfusionsActive Control1 Intervention
FDA approved and already used in this patient population
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,276 Total Patients Enrolled
Marianne Nellis, MD, MSPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
143 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled to have a chest tube placed during surgery before my chest is closed.I am 18 years old or younger.I am scheduled for elective heart-lung machine surgery.I am 19 years old or older.I was born with a bleeding disorder.My family and I refuse blood transfusions due to our beliefs.My baby was born before 38 weeks and needs surgery.I was on a heart-lung machine or heart pump before surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Large volume delayed sampling - LVDS
- Group 2: Pathogen-reduced (PR) platelet transfusions
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrolment opportunities still available for this investigation?
"Correct. According to clinicaltrials.gov, this medical experiment is actively recruiting participants since it was posted on July 5th 2022 and updated recently on August 16th 2022."
Answered by AI
What can be said regarding the safety of Large Volume Delayed Sampling - LVDS for individuals?
"Our organisation has assigned a rating of 3 to the safety profile of Large Volume Delayed Sampling, as this therapy is already approved for use."
Answered by AI
What is the aggregate figure of participants enrolled in this clinical venture?
"Affirmative. Clinicaltrials.gov confirms that this investigation is open to applicants; it was initially posted on July 5th 2022 and subsequently updated on August 16th 2022. To reach their target number of 252 participants, they are accepting patients from two sites."
Answered by AI
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