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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05933135
Other study ID # EK 33-123 ex 20/21
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 8, 2021
Est. completion date December 31, 2023

Study information

Verified date July 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 97
Est. completion date December 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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 Design


Intervention

Drug:
Factor XIII Injection
Patients could have had an Factor XIII Injection in clinical routine

Locations

Country Name City State
Austria Medical University of Graz Graz Styria

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Red cell concentrates Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode 1 year
Secondary Hospitalization Length of the hospital stay caused by the gastrointestinal bleeding episode 1 year
Secondary Interventions Number of endoscopic, radiological, and surgical interventions for bleeding treatment within the hospital stay caused by the gastrointestinal bleeding episode 1 year
Secondary Mortality In hospital-mortality during the hospital stay caused by the gastrointestinal bleeding episode 1 year
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