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Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock

NCT03433508 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-11-05

No results posted yet for this study

Summary

Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb \<8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.

Conditions

  • Cirrhosis

Interventions

BIOLOGICAL

Liberal

2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days

OTHER

Restrictive

To maintain the target Hemoglobin of 7 to 8 gm/dL.

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-15
Primary Completion
2019-02-15
Completion
2019-02-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03433508 on ClinicalTrials.gov