| CTRI Number |
CTRI/2024/01/061840 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To test efficacy of tranexamic acid in the control of bleeding in patients vomiting blood and passing blood in stools. |
|
Scientific Title of Study
|
Efficacy of tranexamic acid and standard management vs standard management in the control of bleeding in patients with upper gastrointestinal bleed: A double-blinded randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRABHAT KHIRWAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
SURGERY UNIT 1, DEPT OF GENERAL SURGERY, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7042652515 |
| Fax |
|
| Email |
prabhat.khirwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
REDDY ABHINAYA P |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
JIPMER |
| Address |
SURGERY UNIT 1, DEPT OF GENERAL SURGERY, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8195014433 |
| Fax |
|
| Email |
reddy.kmc2k6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRABHAT KHIRWAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JIPMER |
| Address |
SURGERY UNIT 1, DEPT OF GENERAL SURGERY, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7042652515 |
| Fax |
|
| Email |
prabhat.khirwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Pondicherry - 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Dhanvantri Nagar, Gorimedu, Pondicherry - 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabhat Khirwar |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Surgery Unit 1, Dept of General Surgery, JIPMER
Pondicherry
PONDICHERRY |
7042652515
prabhat.khirwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K922||Gastrointestinal hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NORMAL SALINE |
The control group will receive 10 ml of normal saline in 100 ml NS over 10 minutes. Followed by an infusion of 20 ml of placebo in 500 ml of NS over 24 hours. |
| Intervention |
TRANEXAMIC ACID |
Patients allotted to the intervention group will receive TXA infusion along with standard management. TXA initial bolus of one gram (10 ml of solution) will be diluted in 100 ml on normal saline and will be given over 10 minutes, followed by slow infusion of two grams of TXA diluted in 500 ml of normal saline will be given over a period of 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
all patients aged above 18 years with ugi bleed |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CONTROL OF BLEEDING |
At baseline and then every 12th hourly for 5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reducing the incidence of early re-bleeding (uptill 72 hours)
Decreasing in the length of ICU and
Decreasing in the in-hospital mortality rate |
5 DAYS |
|
|
Target Sample Size
|
Total Sample Size="252"
Sample Size from India="252"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Upper Gastrointestinal (UGI) bleed is defined as bleeding from the gastrointestinal (GI) tract proximal to the Ligament of Treitz. The incidence of UGI bleed varies from 50-150 / 100,000 per year and is associated with around 10% mortality.
Currently, UGI bleed patients receive octreotide for the reduction of splanchnic blood flow and proton pump inhibitors for the reduction of gastric acid output, along with antibiotics to prevent rebleed and hepatic encephalopathy. Tranexamic acid (TXA) is antifibrinolytic which is being used in controlling bleeding in trauma patients and abnormal uterine bleeding, and it is hypothesised that it can help in controlling upper GI bleed. Early administration of antifibrinolytic agents such as TXA could efficiently help in controlling acute UGI bleed.
Safe pharmacological management for controlling bleeding can significantly reduce the need for surgical interventions, hospital stay and intensive care admissions (ICU) admissions. The addition of TXA to standard management will decrease the proportionate of patients with active bleeding and rebleeding and thereby reducing the overall requirement of blood transfusion, length of hospital stay, length of ICU stay and overall mortality. |