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The study is to compare which threshold of haemoglobin is safer as transfusion cutoff in children with sepsis and multiple organ failure( participants) , with the primary outcome being number of deaths in 28 days.

A pilot randomized controlled trial comparing lower versus higher haemoglobin threshold for transfusion in children with sepsis-associated multi-organ dysfunction. - TRIPS- MODS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097506
Enrollment
60
Registered
2025-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere

Interventions

Intervention1: Lower threshold: Prestored leukodepleted PRBC transfusion on hemoglobin threshold of less than 7g/dl with a target Hb of 7 to 9g/dl.The intervention period will be applied till the ICU

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children admitted to our hospital (PICU and HDU) and satisfying the criteria for the diagnosis of sepsis associated MODS, based on the recent pediatric phoenix sepsis score 2024 for sepsis and PELOD-2 and having atleast one hemoglobin level less than 9 gm/dl

Exclusion criteria

Exclusion criteria: Patients with congenital heart disease. Patients with acute hemorrhagic shock. Patients with hemolytic Anemia Post op cardiac patients Burn injury Post op trauma children Patients who had previous serious adverse reaction to transfusion. Patients with haematological and solid organ malignancy. Those who deny consent to participate in the study.

Design outcomes

Primary

MeasureTime frame
To compare 28 day mortality in children with sepsis associated MODS, when maintained at lower ( 7-9g/dl) vs higher ( 9-11g/dl) hemoglobin concentrationTimepoint: 28 days—

Secondary

MeasureTime frame
Incidence of progressive MODS (PMODS)Timepoint: Till ICU stay or maximum of 28 days;PELOD scores on day 1,3, 5 & 7 after randomizationTimepoint: 7 days ;Vasoactive- inotropic support score (VIS) on day 1,3,5 & 7 after randomizationTimepoint: 7 days ;Need of renal replacement therapyTimepoint: Till ICU stay or maximum of 28 days;Duration of mechanical ventilationTimepoint: Till ICU stay or maximum of 28 days;Length of PICU stayTimepoint: Till ICU stay;Length of hospital stayTimepoint: Till hospital stay;Number(proportion) of adverse events following transfusionTimepoint: Till ICU stay or maximum of 28 days—

Countries

India

Contacts

Public ContactDr Soumya Das

All India Institute of Medical Sciences (Nagpur)

abhijit.choudhary@aiimsnagpur.edu.in8872479496

Outcome results

None listed

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