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

I

Institute of Liver and Biliary Sciences, India

Status

Withdrawn

Conditions

Cirrhosis

Treatments

Biological: Liberal
Other: Restrictive

Study type

Interventional

Funder types

Other

Identifiers

NCT03433508
ILBS-cirrhosis-01

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cirrhosis with septic shock.
  • Age >18 years

Exclusion criteria

  • Previous severe adverse reaction with blood products,
  • Disseminated intravascular coagulopathy
  • HCC
  • Pregnancy
  • Malignancy
  • Active gastrointestinal bleeding
  • Intracranial bleeding
  • Chronic Kidney disease with Maintenance Hemodialysis
  • Pulmonary Edema
  • Congestive Heart Failure
  • Lack of informed consent

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Liberal
Experimental group
Description:
2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days
Treatment:
Biological: Liberal
Restrictive
Active Comparator group
Description:
To maintain the target Hemoglobin of 7 to 8 gm/dL.
Treatment:
Other: Restrictive

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems