Factor XIII Activity in Gastrointestinal Bleedings

Completed

• Conditions: Gastro Intestinal Bleeding
• Interventions: Drug: Factor XIII Injection

• Registration Number: NCT05933135
• Lead Sponsor: Medical University of Graz

Brief Summary

The aim of this retrospective study is to investigate the relationship between factor XIII activity and the outcome of gastrointestinal bleedings. Since factor XIII is of great importance in haemostasis and plays a key role in stabilizing the fibrin clot, it can be assumed that a deficiency of factor XIII leads to an unfavorable course of gastrointestinal bleedings. Our hypothesis is that early detection of such a deficiency can prevent a more severe course and that substitution of factor XIII contributes to faster cessation of bleeding, improves patient outcome and reduces the number of red cell concentrates required.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Primary Completion: 2022-12-31
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-07-04
• Study First Posted: 2023-07-06
• Study Completion: 2023-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

Inclusion Criteria

• Age over 18 years
• Confirmed diagnosis of gastrointestinal bleeding
• Assessment of factor XIII activity during the gastrointestinal bleeding episode

Exclusion Criteria

• Age under 18 years
• Diagnosis of hemophilia A or B or other congenital coagulation disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Reduced factor XIII activity	Factor XIII Injection	Patients with GI bleeding and reduced factor XIII activity

Primary Outcome Measures

Name	Time	Method
Red cell concentrates	1 year	Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode

Secondary Outcome Measures

Name	Time	Method
Hospitalization	1 year	Length of the hospital stay caused by the gastrointestinal bleeding episode
Interventions	1 year	Number of endoscopic, radiological, and surgical interventions for bleeding treatment within the hospital stay caused by the gastrointestinal bleeding episode
Mortality	1 year	In hospital-mortality during the hospital stay caused by the gastrointestinal bleeding episode

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria