Clinical Trials Logo

Clinical Trial Summary

The Pilot Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (P-OpTTICCA) study is a pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial. The primary outcome of the pilot study is feasibility.


Clinical Trial Description

Patients in paediatric intensive care units (PICU) are among the main groups of transfusion recipients. Blood transfusions expose recipients to infectious and non-infectious serious hazards. Despite an increasing number of red blood cell (RBC) transfusion threshold randomised controlled trials (RCT) to date, only one large RCT, the Transfusion Requirement In PICU (TRIPICU) study (Lacroix. N Engl J Med 2007;356:1609-19) informs practice in PICU. This dearth of paediatric data was reiterated by a recent National Heart, Lung and Blood Institutes state of the art symposium. Despite being internally robust, the generalizability of TRIPICU has been questioned given that nearly 90% of critically ill children with haemoglobin (Hb) level ≤ 95 g/L were not enrolled for a range of pre-specified reasons including severity of illness, clinical instability and uncertain physician buy-in, thus threatening broader application of this critical knowledge into practice. Recent data and evidence summarised in systematic reviews support the need to explore the benefits and safety of Hb threshold ≤ 70 g/L for almost all critically ill children, not only those who would have been enrolled in TRIPICU. We propose an international pilot study that will inform the design of a large pragmatic non-inferiority RCT (termed OpTTICCA) conceived to derive generalizable transfusion guidance for physicians. Objectives of the pilot-RCT. Specific aims are to: 1. Establish the feasibility of enrolling ≥80% of eligible patients. 2. Document adherence to study intervention ≥80% (restrictive transfusion policy). 3. Assess the incidence rate of the primary outcome measure of the full RCT (new and progressive multiple organ dysfunction syndrome, which includes mortality). 4. Establish the feasibility of using routinely collected clinical information from electronic medical data monitoring system (eMDMS) to enhance cost-efficiency. In the pilot-RCT, we will enrol 120 patients (20 to 40/site) in PICUs equipped with electronic medical data monitoring system (eMDMS). This trial builds on successful prior RCTs that involved international collaboration and funding (Canada, United Kingdom, France): TRIPICU, Age of Blood Evaluation (ABLE) (Lacroix. N Engl J Med 2015) and Age of Blood in Children in PICU (ABC-PICU study: Tucci et al. Trials 2018). The pilot-RCT will be considered as the vanguard phase of the full OpTTICCA RCT if no important design changes are required. Expected results. This pilot-RCT will focus on feasibility parameters. It will explore whether we can 1) recruit a much broader eligible patient group, 2) assess protocol adherence, 3) assess the primary outcome measure, and 4) abstract most data electronically. A definitive trial will provide transfusion guidance for many important subgroups in whom evidence is presently lacking including children admitted with bone marrow failure, head injury, some cardiac disorders, and sepsis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03871244
Study type Interventional
Source St. Justine's Hospital
Contact Jacques Lacroix
Phone 514-345-4931
Email jacques.lacroix.med@ssss.gouv.qc.ca
Status Recruiting
Phase Phase 3
Start date June 3, 2020
Completion date December 31, 2022

See also
  Status Clinical Trial Phase
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Completed NCT02948283 - Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia Phase 1
Completed NCT03341338 - Genes-in-Action - Hepcidin Regulation of Iron Supplementation
Completed NCT00060398 - Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer Phase 3
Recruiting NCT05384691 - Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions Phase 2
Active, not recruiting NCT02101944 - Wild-Type Reovirus in Combination With Carfilzomib and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Not yet recruiting NCT06309641 - Methemoglobinemia Following Intravenous Iron Treatment
Completed NCT03822884 - Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Phase 1
Completed NCT02912533 - A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02930850 - Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation N/A
Completed NCT02912494 - A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD) Phase 3
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02384122 - Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias Phase 3
Completed NCT02603250 - Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda N/A
Completed NCT02176759 - Iron Absorption From Rice Fortified With Ferric Pyrophosphate N/A
Completed NCT02310113 - Transfusion and Skeletal Muscle Tissue Oxygenation N/A
Withdrawn NCT01934842 - A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate N/A
Completed NCT01922479 - Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure Phase 4
Completed NCT01693029 - Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa Phase 3
Completed NCT01458028 - Age and Gender Effects on the Pharmacokinetics of BAY85-3934 Phase 1