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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. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2017/09/009682 |
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Date of registration:
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07-09-2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Upper digestive tract bleeding-how much blood to transfuse?
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Scientific title:
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Restrictive vs. Liberal transfusions strategy in patients with upper gastrointestinal bleeding รข?? A randomized controlled trial. |
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Date of first enrolment:
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05-01-2016 |
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Target sample size:
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224 |
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Recruitment status: |
Closed to Recruitment of Participants |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14478 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable
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Phase:
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Phase 3/ Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Sreenath GS
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Address:
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Department of Surgery
Jawaharlal Institute of Post Graduate Medical Education and Research
Dhanvanthri Nagar
605006
Pondicherry, PONDICHERRY
India |
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Telephone:
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9486690883 |
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Email:
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dr.sreenathgs@gmail.com |
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Affiliation:
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Jawaharlal Institute of Post Graduae Medical Education and Research |
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Name:
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Dr Sreenath GS
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Address:
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Department of Surgery
Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvanthri Nagar
Puducherry
605006
Pondicherry, PONDICHERRY
India |
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Telephone:
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9486690883 |
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Email:
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dr.sreenathgs@gmail.com |
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Affiliation:
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Jawaharlal Institute of Post Graduae Medical Education and Research |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients >18 years of age presenting with upper GI bleeding with hemoglobin level <10 g/dl
Exclusion criteria: Massive exsanguinating bleeding.
Lower GI bleed.
An acute coronary syndrome
Symptomatic peripheral vasculopathy.
Stroke, transient ischemic attack.
Transfusion within 90 days.
A recent history of trauma or surgery.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: null- Upper Gastrointestinal bleeding
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Intervention(s)
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Intervention1: Restrictive transfusion: Transfusing the patient when the hemoglobin is less than 7g/dl till a level of 9g/dl is reached
Control Intervention1: Liberal transfusion: Transfusing the patient when hemoglobin is less than 8g/DL till a level of 10g/DL is reached
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Primary Outcome(s)
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MORTALITY
MORBIDITYTimepoint: 45 DAYS
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Secondary Outcome(s)
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Banding or sclerotherapyTimepoint: 45 days
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Dose and duration of octreotideTimepoint: 45 days
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Length of hospital stayTimepoint: 45 days
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Number of sessions of endoscopic treatmentTimepoint: 45 days
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Rebleeding episodesTimepoint: 45 days
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Death from any cause within 45 daysTimepoint: 45 days
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Requirement of Sengstaken Blakemore tube placementTimepoint: 45 days
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Source(s) of Monetary Support
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JIPMER Hospital
Dhanvanthri Nagar
Puducherry 605006
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Ethics review
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Status: Approved
Approval date: 25/06/2015
Contact:
Institute Ethics Committee- JIPMER
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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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