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Completed

NCT Number: NCT05933135

Factor XIII Activity in 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.

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Key information

Conditions

Gastro Intestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, Styria, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Factor XIII Injection

Drug

Patients could have had an Factor XIII Injection in clinical routine

Primary outcomes

  1. Red cell concentrates

    Time frame: 1 year

    Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode

Secondary outcomes

  1. Hospitalization

    Time frame: 1 year

    Length of the hospital stay caused by the gastrointestinal bleeding episode

  2. Interventions

    Time frame: 1 year

    Number of endoscopic, radiological, and surgical interventions for bleeding treatment within the hospital stay caused by the gastrointestinal bleeding episode

  3. Mortality

    Time frame: 1 year

    In hospital-mortality during the hospital stay caused by the gastrointestinal bleeding episode

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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