Factor XIII Activity in Gastrointestinal Bleedings

NCT ID: NCT05933135

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-08

Study Completion Date

2023-12-31

Brief Summary

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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

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Conditions

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Gastro Intestinal Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Normal factor XIII acitivity

Patients with GI bleeding and normal factor XIII activity

No interventions assigned to this group

Reduced factor XIII activity

Patients with GI bleeding and reduced factor XIII activity

Factor XIII Injection

Intervention Type DRUG

Patients could have had an Factor XIII Injection in clinical routine

Interventions

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Factor XIII Injection

Patients could have had an Factor XIII Injection in clinical routine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christoph Hoegenauer, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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EK 33-123 ex 20/21

Identifier Type: -

Identifier Source: org_study_id

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