NCT04489108

Brief Summary

The management of acute upper gastrointestinal bleeding (UGIB) is challenging in patients with cirrhosis, as it is responsible for severe complications and high mortality rates. Fibrinolytic activity of the epithelial surfaces and of the submucosal blood vessels may interfere with hematemesis and even delay healing of ulcers. Tranexamic acid (TXA) may help control the bleeding by counterbalancing cirrhosis-related hyperfibrinolysis. Still, there is a lack of unbiased data to conclude on its efficacy. Tranexamic Acid in patients with acute Upper Gastrointestinal bleed have been shown to prevent re bleed in few studies when combined with standard medical management (which generally comprises of initial fluid resuscitation, intravenous PPI , splanchnic vasoconstrictors, blood transfusions and coagulopathy corrections as per lab parameters) but no randomized placebo controlled trial has been done. The aim of this study is to evaluate the efficacy of TXA in the early treatment of acute UGIB as compared to placebo in patients with cirrhosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 5, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

January 31, 2022

Status Verified

January 1, 2022

Enrollment Period

1.5 years

First QC Date

July 20, 2020

Last Update Submit

January 27, 2022

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients developing five-day treatment failure in both the groups

    5 day

Secondary Outcomes (12)

  • Number of patients with failure to prevent rebleed in both group

    6 weeks

  • Clinically significant rebleed in both groups

    6 weeks

  • Number of patients who will require salvage therapy in both groups

    6 weeks

  • Number of patients who will require Blood product and component in both groups

    6 weeks

  • Number of days in Intensive Care Unit in both groups

    6 weeks

  • +7 more secondary outcomes

Study Arms (2)

Tranexamic Acid with Standard Medical Treatment

EXPERIMENTAL

Arm A will Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours along with standard medical and interventional (Endoscopy) therapy.

Drug: Tranexamic acidOther: Standard Medical Treatment

Placebo + Standard Medical treatment

ACTIVE COMPARATOR

Arm B will receive similar volume of isotonic solution (saline) along with standard medical and interventional (Endoscopy) therapy.

Other: Standard Medical TreatmentOther: Placebo

Interventions

Tranexamic acidDRUG

Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours

Tranexamic Acid with Standard Medical Treatment
Standard Medical TreatmentOTHER

Standard Medical Treatment

Placebo + Standard Medical treatmentTranexamic Acid with Standard Medical Treatment
PlaceboOTHER

isotonic solution (saline)

Placebo + Standard Medical treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients greater than 18 years of age
  • Presenting with Acute UGI bleed (\< 24hrs from onset).
  • Cirrhosis (Known Or suspected on clinical, biological, radiological data or the patient's history) with CTP B / C (i.e. CTP \>/=7) or ACLF (with clinical evidence of cirrhosis).

You may not qualify if:

  • Non cirrhotic patients
  • Known allergy to Tranexamic Acid
  • Patients with clinical evidence of DIC (Disseminated Intravascular Coagulation) like coagulopathy patches/ haematuria / uncontrolled epistaxis etc.
  • Patients with Chronic Kidney Disease.
  • History of recent Cerebro Vascular Accident (CVA) \[in the past 6 months\] or patients with thrombotic events \[Portal Vein thrombosis /Hepatic vein thrombosis /other sites thrombosis\]. HCC with tumour thrombosis will be included
  • Any history of seizures, myocardial infarction
  • Pregnancy/lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Dr Shantan Venishetty, MD

CONTACT

01146300000venishantan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 28, 2020

Study Start

November 5, 2020

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

January 31, 2022

Record last verified: 2022-01

Locations

IN(1)