Factor XIII Activity in Gastrointestinal Bleedings

Sponsor

Medical University of Graz (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05933135

Collaborator

(none)

Enrollment

Location

35.7

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastro Intestinal Bleeding	Drug: Factor XIII Injection

Study Design

Study Type:

Observational

Actual Enrollment :

97 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings

Actual Study Start Date :

Jan 8, 2021

Actual Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 Patients could have had an Factor XIII Injection in clinical routine

Arm

Intervention/Treatment

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

Patients could have had an Factor XIII Injection in clinical routine

Outcome Measures

Primary Outcome Measures

Red cell concentrates [1 year]
Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode

Secondary Outcome Measures

Hospitalization [1 year]
Length of the hospital stay caused by the gastrointestinal bleeding episode
Interventions [1 year]
Number of endoscopic, radiological, and surgical interventions for bleeding treatment within the hospital stay caused by the gastrointestinal bleeding episode
Mortality [1 year]
In hospital-mortality during the hospital stay caused by the gastrointestinal bleeding episode

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz	Styria	Austria	8036

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator: Christoph Hoegenauer, Prof., Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT05933135

Other Study ID Numbers:

EK 33-123 ex 20/21

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 6, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastrointestinal Hemorrhage

Hemorrhage

Study Results

No Results Posted as of Jul 6, 2023