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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

Must not have

Gestationally-corrected age < 37 weeks

Hemoglobinopathies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-randomization (+/- 2 mo)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was younger than 6 years old when I received ECMO treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My baby was born before 37 weeks of pregnancy.

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I have a blood disorder affecting my hemoglobin.

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I was put on ECMO at a different hospital and then moved to a trial site.

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I have discussed or decided on care limits after starting ECMO treatment.

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I have a bleeding disorder I was born with.

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I was first treated with VV-ECMO and then switched to VA ECMO.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-randomization (+/- 2 mo)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Acute kidney injury > stage 2

Adaptive Behavior Assessment System-3 (ABAS-3)

All-cause mortality

+23 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%

Study treatment Arm

Restrictive Transfusion Strategy

Liberal Transfusion Strategy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met