Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03433508 |
Date of registration:
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08/02/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock
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Scientific title:
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Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial |
Date of first enrolment:
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December 15, 2018 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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https://clinicaltrials.gov/show/NCT03433508 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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India
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cirrhosis
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Intervention(s)
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Other: Restrictive
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Biological: Liberal
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Primary Outcome(s)
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Mortality in both groups
[Time Frame: 28 dyas]
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Secondary Outcome(s)
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Requirement of mechanical ventilation in both groups
[Time Frame: 28 days]
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Length of ICU (Intensive Care Unit) stay
[Time Frame: 28 days]
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Improvement in vasopressors in both groups
[Time Frame: 28 days]
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Incidence of complications in both groups
[Time Frame: 28 days]
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Secondary ID(s)
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ILBS-cirrhosis-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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