Factor XIII Activity in Gastrointestinal Bleedings

NCT05933135 | Completed

• 1 other identifier: EK 33-123 ex 20/21
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro Intestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• Red cell concentrates

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

  1 year

Secondary Outcomes (3)

• Hospitalization

  1 year

• Interventions

  1 year

• Mortality

  1 year

Study Arms (2)

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

Interventions

Factor XIII Injection DRUG

Patients could have had an Factor XIII Injection in clinical routine

Reduced factor XIII activity

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Factor XIII

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Christoph Hoegenauer, Prof.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: July 6, 2023
• Study Start: January 8, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)