Factor XIII Activity in Gastrointestinal Bleedings

Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings

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.

Study Overview

• Status: Completed
• Conditions: Gastro Intestinal Bleeding
• Intervention / Treatment: Drug: Factor XIII Injection

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medical University of Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients were retrospectively recruited if they suffered an episode of a gastrointestinal bleeding and factor XIII was measured.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal factor XIII acitivity; Patients with GI bleeding and normal factor XIII activity
Reduced factor XIII activity; Patients with GI bleeding and reduced factor XIII activity	Drug: Factor XIII Injection; Patients could have had an Factor XIII Injection in clinical routine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Red cell concentrates	Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Christoph Hoegenauer, Prof., Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: July 4, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: EK 33-123 ex 20/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No