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Single centre Single arm Intervention study to Check safety and effectiveness of Troylase in the treatment of Hemostasis of Active Variceal Bleeding

A prospective, open label Single centre Single arm Intervention study to evaluate safety and effectiveness of Troylase in the treatment of Hemostasis of Active Variceal Bleeding

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/09/027880
Enrollment
50
Registered
2020-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D68- Other coagulation defects

Interventions

Intervention1: Troylase 1NIH (Hemocoagulase 1NIH) Injection: Adults are given 1 ampoule of Troylase subcutaneously or intramuscularly and if blood loss is serious 1 ampoule intravenously and 1ampoule

Sponsors

Asian Institute of Gatroentrology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Bleeding Esophageal and / or Gastric varices

Exclusion criteria

Exclusion criteria: Contraindicated to undergo endoscopy, already hospitalized for another illness Pregnant or lactating Patients with altered post-surgical anatomy of the stomach Patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of Troylase

Design outcomes

Primary

MeasureTime frame
Proportion of patients with acute (procedural) hemostasis in 24 hour period, and the rate of recurrent bleeding within 72 hours of treatmentTimepoint: 24 hr and 72 hr

Secondary

MeasureTime frame
Incidence of all Adverse Events (AEs), non-serious and serious, possibly related to or related to the procedure and/or drug that are experienced by study participantsTimepoint: 24 hr and 72 hr

Countries

India

Contacts

Public ContactDr Manu Tandon

Asian Institute of Gastroentrology

mantan_05@rediffmail.com04023378888

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026