Clinical trial

Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings

Name

EK 33-123 ex 20/21

Description

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.

Trial arms

Trial start

2021-01-08

Estimated PCD

2022-12-31

Trial end

2023-12-31

Status

Active (not recruiting)

Treatment

Factor XIII Injection

Patients could have had an Factor XIII Injection in clinical routine

Arms:

Reduced factor XIII activity

Size

Primary endpoint

Red cell concentrates

1 year

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 97, 'type': 'ACTUAL'}}

Updated at

2023-07-06

1 organization

1 product

1 indication

Organization

Medical University of Graz

Product

Factor XIII

Indication

Gastrointestinal Bleeding