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A clinical trial to compare lower(hemoglobin threshold for PRBC transfusion 7 gm/dl) vs higher hemoglobin threshold (hemoglobin threshold for PRBC transfusion 9 gm/dl) for transfusion in children with acute respiratory distress syndrome

A PILOT RANDOMIZED CONTROLLED TRIAL COMPARING â??LOWER VERSUS HIGHER HEMOGLOBIN THRESHOLDâ?? FOR TRANSFUSION IN CHILDREN WITH ACUTE RESPIRATORY DISTRESS SYNDROME. - TRICARDS

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/01/007726
Enrollment
50
Registered
2017-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Pediatric Acute Respiratory Distress Syndrome(ARDS)

Interventions

Intervention1: Leucoreduced Packed Red blood cell: GroupI Will receive PRBC if hemoglobin less than 7 gm/dl Group II will receive PRBC if hemoglobin less than 9 gm/dl Intervention2: Leukoreduced Packe

Sponsors

PGIMER CHANDIGARH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 1 month- 12 years admitted to our hospital and satisfying the criteria for the diagnosis of ARDS based on the recent pediatric specific definition proposed by Pediatric Acute Lung Injury Consensus Conference Group investigators any time during the hospital stay and on invasive mechanical ventilation and having atleast one hemoglobin level less than 9 gm/dl within 1 week of diagnosis of ARDS with no exclusion criteria will be included in study. .

Exclusion criteria

Exclusion criteria: 1 Those who deny consent to participate in the study. 2 Patients with cyanotic heart disease. 3 Patients with acute hemorrhagic shock. 4 Patients with chronic hemolytic Anemia 5 Patients who had previous adverse reaction to transfusion. 6 Patients with hematological and solid organ malignancy. 7 Patients who received transfusion within 48 hours before enrolling in the study

Design outcomes

Primary

MeasureTime frame
28 day MortalityTimepoint: 28th day after randomization

Secondary

MeasureTime frame
28 day Ventilator Free daysTimepoint: 28th day after randomization;Daily Oxygenation index/Oxygen saturation indexTimepoint: During hospital stay;Daily PELOD scoresTimepoint: During hospital stay;Incidence of new onset MODS/ progression of MODSTimepoint: After first PRBC transfusion event;Length of Hospital stayTimepoint: During hospital stay;Length of PICU stayTimepoint: During hospital stay;Number of Adverse Events following PRBC transfusionTimepoint: During hospital stay

Countries

India

Contacts

Public ContactJayashree M

PGIMER, Chandigarh

mjshree@hotmail.com09815594343

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026