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Blood Product

Red Blood Cell Transfusion Strategies for ECMO Patients (TITRE Trial)

N/A
Recruiting
Led By Lynn A. Sleeper, ScD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age < 6 year at ECMO cannulation
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post-randomization (+/- 2 mo)
Awards & highlights

TITRE Trial Summary

This trial will compare two different transfusion strategies for children on ECMO support to see which one leads to better outcomes.

Who is the study for?
This trial is for critically ill children under 6 years old on their first ECMO run with veno-arterial mode. It's not for kids expected to have care limitations within 48 hours, those with congenital bleeding disorders or hemoglobinopathies, non-residents of the US/Canada, or those on short-term ECMO.Check my eligibility
What is being tested?
The TITRE study tests if limiting red blood cell transfusions based on specific needs (like bleeding or low tissue oxygen) is better than using set hemoglobin levels. The goal is to see if this can reduce organ dysfunction and improve neurodevelopment in these children.See study design
What are the potential side effects?
Potential side effects from red blood cell transfusions may include allergic reactions, fever, iron overload, lung injury, and infection risk. However, individual experiences with side effects can vary.

TITRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was younger than 6 years old when I received ECMO treatment.

TITRE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post-randomization (+/- 2 mo)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-randomization (+/- 2 mo) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline-adjusted change in pSOFA (pediatric Sequential Organ Failure Assessment) score
Bayley Infant Scales of Development, 4th edition (Bayley-4)
Wechsler Preschool and Primary Scale of Intelligence (WPPSI - IV)
Secondary outcome measures
Acute kidney injury > stage 2
Adaptive Behavior Assessment System-3 (ABAS-3)
All-cause mortality
+25 more

Side effects data

From 2012 Phase 3 trial • 110 Patients • NCT01167582
19%
Death at 6 months
13%
Myocardial Infarction at 30 days
13%
Congestive Heart Failure at 30 Days
100%
80%
60%
40%
20%
0%
Study treatment Arm
Restrictive Transfusion Strategy
Liberal Transfusion Strategy

TITRE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Center-specific hemoglobin/hematocrit threshold-based red blood cell transfusion strategyExperimental Treatment1 Intervention
Red blood cell transfusion will occur according to each study center's standard of care strategy, typically based on a particular hemoglobin threshold or hematocrit threshold. When hemoglobin or hematocrit decrease to the threshold, red blood cell transfusion is administered.
Group II: Indication-based red blood cell transfusion strategyActive Control1 Intervention
Red blood cell transfusion will occur if the center-specific hemoglobin/hematocrit threshold for transfusion is met AND at least one of the following conditions is present: a) moderate or severe bleeding; b) reduced tissue oxygen delivery, defined as serum lactate >5 mmol/L or 2 serum lactate levels > 3 mmol/L measured 2 hours apart; or c) hemoglobin < 8 g/dL or hematocrit < 25%, except for neonates (age =< 28 d) and children with single ventricle congenital heart disease (age < 1 y) RBC transfusion for hemoglobin < 10g/dL or hematocrit <30% is allowed.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
758 Previous Clinical Trials
5,579,082 Total Patients Enrolled
Lynn A. Sleeper, ScDPrincipal InvestigatorBoston Children's Hospital

Media Library

Red blood cell transfusion (Blood Product) Clinical Trial Eligibility Overview. Trial Name: NCT05405426 — N/A
Extracorporeal Membrane Oxygenation Research Study Groups: Indication-based red blood cell transfusion strategy, Center-specific hemoglobin/hematocrit threshold-based red blood cell transfusion strategy
Extracorporeal Membrane Oxygenation Clinical Trial 2023: Red blood cell transfusion Highlights & Side Effects. Trial Name: NCT05405426 — N/A
Red blood cell transfusion (Blood Product) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405426 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being accepted for this research venture currently?

"According to clinicaltrials.gov, this medical study is not presently enrolling patients. Although first posted on January 1st 2023 and amended June 27th 2022, there are 31 other trials currently in recruitment mode."

Answered by AI

What outcomes is this experiment attempting to demonstrate?

"This clinical trial's primary goal is to assess the Bayley Infant Scales of Development, 4th edition (Bayley-4) over a specified period. Secondary objectives include quantifying ICU free days and total blood product administration as well as measuring mixed venous oxygen saturation."

Answered by AI

Would I be eligible to join this clinical investigation?

"The scope of this trial requires that participants have multiple organ failure and are within the age range of 1 day to 6. Up to 228 individuals could potentially qualify for acceptance into the study."

Answered by AI

Does this clinical trial accept participants who are over 55 years of age?

"As outlined in the entry requirements, the minimum age to join this study is 1 day and no participant should exceed 6 years old."

Answered by AI

In how many settings is the experiment being conducted?

"Currently, the trial is recruiting from 18 locations including Children's Hospital Colorado in Aurora and Washington University in St. Louis School of Medicine. Additionally, there are an additional 15 sites spread across the United States offering this medication to patients."

Answered by AI
~80 spots leftby Oct 2024