Extracorporeal Membrane Oxygenation Clinical Trial
Official title:
TITRE: Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support.
Observational studies of children on ECMO have shown an association between large-volume RBC transfusion and mortality. However, the hematocrit (or hemoglobin) level at which optimal tissue oxygen delivery occurs is unknown. TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a prospective, randomized clinical trial to be conducted at 18-20 study sites. The overarching goal of TITRE is to determine whether restricting RBC transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving ECMO support. Aim 1: To test whether children < 6 years of age on ECMO support who are randomized to a strategy of indication-based versus center-specific threshold-based RBC transfusion will have greater improvement in organ function. Aim 2: To test whether survivors among children age < 6 years on ECMO support who are randomized to indication-based compared to center-specific threshold-based RBC transfusion will have better neurodevelopmental outcomes and health-related QOL at one year post-randomization. Key design features include: Randomization stratified by patient age (neonate: =< 28d vs. non-neonate) and by diagnosis (CHD vs. other diagnosis); and a target sample size of 228 patients. Endpoints will be evaluated during ECMO, at hospital discharge, and at 3, 6, 9, and 12 months. To ensure trial integrity, the primary outcome (pSOFA: Pediatric Sequential Organ Failure Assessment score) will be adjudicated by an independent committee and neurodevelopmental assessments will be blinded. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03685383 -
Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation
|
N/A | |
Not yet recruiting |
NCT05106491 -
Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock Patients
|
N/A | |
Recruiting |
NCT05699005 -
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
|
Phase 1 | |
Recruiting |
NCT05444764 -
PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
|
||
Completed |
NCT05038943 -
Evaluation of Safety and Effectiveness of The SherpaPak in Donation After Circulatory Death Heart Transplantation
|
N/A | |
Not yet recruiting |
NCT05341687 -
Prognostic Value of Respiratory System Compliance Under VV-ECMO on 180-day Mortality in COVID-19 ARDS.
|
||
Suspended |
NCT04385771 -
Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation
|
N/A | |
Recruiting |
NCT03766282 -
Pharmacokinetics in Extracorporeal Membrane Oxygenation
|
||
Completed |
NCT03355625 -
Platelet Function During Extracorporeal Membrane Oxygenation in Adult Patients
|
||
Completed |
NCT01521195 -
Oxygen Consumption In Critically Ill Children
|
N/A | |
Recruiting |
NCT04620070 -
ON-SCENE Initiation of Extracorporeal CardioPulmonary Resuscitation During Refractory Out-of-Hospital Cardiac Arrest
|
N/A | |
Recruiting |
NCT06062212 -
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
|
||
Recruiting |
NCT05730114 -
Monitoring Antiplatelet Drugs in Cardiac Arrest Patients
|
||
Completed |
NCT05154071 -
Impact of the Implementation of a Referral Veno-venous Extracorporeal Membrane Oxygenation Centre on Mortality
|
||
Recruiting |
NCT04536272 -
Reduced Anticoagulation Targets in ECLS (RATE)
|
Phase 3 | |
Completed |
NCT05693051 -
Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
|
||
Completed |
NCT03764319 -
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO
|
N/A | |
Recruiting |
NCT05762029 -
Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
|
||
Completed |
NCT02995811 -
Characterising Changes in Muscle Quantity and Quality in Patients Requiring ECMO Oxygen During Critical Illness
|
||
Recruiting |
NCT04754854 -
Reduction of Blood Recirculation in Veno-Venous ECMO
|