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NCT06881628
Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients
Phase 4 trial testing Tranexamic Acid and vitamin K in Upper Gastrointestinal Bleeding (UGIB) in 194 participants. Currently enrolling.
15 December 2025
Quick facts
| Lead sponsor | Tanta University |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 194 |
| Start date | 2 December 2024 |
| Primary completion | 15 December 2025 |
| Estimated completion | 30 December 2025 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Tranexamic Acid and vitamin K — full drug profile →
- Placebo
Conditions studied
- Upper Gastrointestinal Bleeding (UGIB) — all drugs for Upper Gastrointestinal Bleeding (UGIB) →
- Variceal Bleeding — all drugs for Variceal Bleeding →
- Cirrhosis — all drugs for Cirrhosis →
Sponsor
Tanta University
Who can join
18 and older, any sex, with Upper Gastrointestinal Bleeding (UGIB) or Variceal Bleeding. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. Participants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy. Follow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital. The rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups. At discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis. Second follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06881628
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Related trials
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Currently open trials in the same condition.
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Other Tanta University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06881628 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tanta University
- Last refreshed: 18 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06881628.
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