Recruiting
Phase 3

Transfusion Thresholds

Sponsor:

St. Justine's Hospital

Code:

NCT03871244

Conditions

Anemia

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Less red blood cell transfusions

More red blood cell transfusion (standard transfusion strategy in PICU)

Study Details

Brief 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.

Conditions

Anemia

Study ID

NCT03871244

Start date

Jun 3, 2020

Status verified date

Sep, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1. Hemoglobin concentration ≤ 95 g/L, while in PICU
  • 2. Not already participating to a randomized controlled trial on hemoglobin threshold to guide red blood cell transfusion practice

Exclusion Criteria:

1. Post conception age ≤ 36 weeks or > 18 years at PICU entry
2. Refusal of consent by patient and/or parent
3. Uncorrected cyanotic cardiac disease, univentricular physiology
4. Sickle cell disease
5. Brain Death
6. Extracorporeal membrane oxygenation (ECMO)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Restrictive arm (intervention)

Less red blood cell transfusions. The protocol will require that no red blood cell transfusion be given unless the hemoglobin level is below or equal at 70 g per L.

active comparator: Standard care arm (comparator)

Clinical teams will follow their usual transfusion practices.

Interventions

Less red blood cell transfusions

The instructions given to caregivers will be to consider prescribing a red blood cell transfusion only if the hemoglobin level is ≤ 70 g per L.

More red blood cell transfusion (standard transfusion strategy in PICU)

The instructions given to caregivers will be to prescribe a red blood cell transfusion according to their usual standard practice

Primary outcome measure

  • Recruitment: screening [ Time Frame: One year ]
  • Recruitment: consent [ Time Frame: One year ]
  • Recruitment: enrolment [ Time Frame: One year ]

Central Contacts and Locations

Central contacts

Jacques Lacroix

514-345-4931jacques.lacroix.med@ssss.gouv.qc.ca

Josee Poirier

514-345-4931josee.poirier.hsj@ssss.gouv.qc.ca

Locations

CHU Sainte-Justine

Recruiting

Montréal, Quebec, Canada, H3T 1C5

Contacts

Josée Poirier

514-345-4931josee.poirier.hsj@ssss.gouv.qc.ca

More Information

Sponsor

St. Justine's Hospital

Last update posted

Sep 28, 2021

Last verified

Sep, 2021

Keywords

  • hemoglobin threshold
  • critically ill children
  • randomized controlled trial
  • red blood cell tranfusions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Justine's Hospital on 2021-09-28.