Factor XIII Activity in Gastrointestinal Bleedings

Gastro Intestinal Bleeding Clinical Trial

Official title:

Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05933135
• Other study ID #: EK 33-123 ex 20/21
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Gastro Intestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

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