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

Primary Purpose

Cirrhosis

Status
Withdrawn
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Liberal
Restrictive
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Cirrhosis with septic shock.
  2. Age >18 years

Exclusion Criteria:

  1. Previous severe adverse reaction with blood products,
  2. Disseminated intravascular coagulopathy
  3. HCC
  4. Pregnancy
  5. Malignancy
  6. Active gastrointestinal bleeding
  7. Intracranial bleeding
  8. Chronic Kidney disease with Maintenance Hemodialysis
  9. Pulmonary Edema
  10. Congestive Heart Failure
  11. Lack of informed consent

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liberal

Restrictive

Arm 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

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

Outcomes

Primary Outcome Measures

Mortality in both groups

Secondary Outcome Measures

Improvement in vasopressors in both groups
Improvement is defined as tapering the dose of vasopressors
Incidence of complications in both groups
Length of ICU (Intensive Care Unit) stay
Requirement of mechanical ventilation in both groups

Full Information

First Posted
February 8, 2018
Last Updated
November 1, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT03433508
Brief Title
Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock
Official Title
Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
lack of funds
Study Start Date
December 15, 2018 (Anticipated)
Primary Completion Date
February 15, 2019 (Anticipated)
Study Completion Date
February 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liberal
Arm Type
Experimental
Arm 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
Arm Title
Restrictive
Arm Type
Active Comparator
Arm Description
To maintain the target Hemoglobin of 7 to 8 gm/dL.
Intervention Type
Biological
Intervention Name(s)
Liberal
Intervention 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
Intervention Type
Other
Intervention Name(s)
Restrictive
Intervention Description
To maintain the target Hemoglobin of 7 to 8 gm/dL.
Primary Outcome Measure Information:
Title
Mortality in both groups
Time Frame
28 dyas
Secondary Outcome Measure Information:
Title
Improvement in vasopressors in both groups
Description
Improvement is defined as tapering the dose of vasopressors
Time Frame
28 days
Title
Incidence of complications in both groups
Time Frame
28 days
Title
Length of ICU (Intensive Care Unit) stay
Time Frame
28 days
Title
Requirement of mechanical ventilation in both groups
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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