Status:

UNKNOWN

Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia

Lead Sponsor:

St. Justine's Hospital

Collaborating Sponsors:

Oxford University Hospitals NHS Trust

Hôpital Jeanne de Flandre

Conditions:

Anemia

Eligibility:

All Genders

1-18 years

Phase:

PHASE3

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 randomis...

Detailed 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 a...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

June 3 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT03871244

Start Date

June 3 2020

End Date

December 31 2022

Last Update

September 28 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

CHU Sainte-Justine

Montreal, Quebec, Canada, H3T 1C5