Recruiting PHASE4 Upper Gastrointestinal Bleeding (UGIB)

New treatment option for Upper Gastrointestinal Bleeding (UGIB)

Official title Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients

ClinicalTrials.gov ID: NCT06881628

What this study is testing

What is Tranexamic Acid and vitamin K?

Tranexamic Acid and vitamin K is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for upper gastrointestinal bleeding (ugib).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients. Researchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo.
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Age ≥18 years
  • Liver cirrhosis
  • Upper gastrointestinal bleeding

You likely can't join if

  • Patients aged \< 18 years
  • Allergy to tranexamic acid
  • Allergy to vitamin K injection
  • DIC.
  • Thromboembolic event.
  • Pregnancy or lactation.
See the full eligibility criteria
Who can join
  • Age ≥18 years
  • Liver cirrhosis
  • Upper gastrointestinal bleeding
What rules you out
  • Patients aged \< 18 years
  • Allergy to tranexamic acid
  • Allergy to vitamin K injection
  • DIC.
  • Thromboembolic event.
  • Pregnancy or lactation.
  • End-stage renal disease.
  • Unwilling to participate in our study.

The study team makes the final eligibility decision.

Where it's taking place

  • Tanta, Gharbyea, Egypt

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Tanta, Gharbyea, Egypt. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.