Factor XIII Activity in Gastrointestinal Bleedings | NCT05933135

Studies
Factor XIII Activity in Gastrointestinal Bleedings

NCT05933135

Sponsor

Medical University of Graz

Status

Completed

Last Update Posted

Mar 25, 2025Actual

Enrollment

97Actual

Phase

Not provided

Conditions

Gastro Intestinal Bleeding

Interventions

Factor XIII Injection

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 8, 2021Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Feb 20, 2023

First Submission Date that Met QC Criteria

Jul 4, 2023

First Posted Date

Jul 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2025

Last Update Posted Date

Mar 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Factor XIII Injection	Drug	Patients could have had an Factor XIII Injection in clinical routine	Reduced factor XIII activity

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Red cell concentrates	Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode	1 year

Secondary Outcomes

Measure	Description	Time Frame
Hospitalization	Length of the hospital stay caused by the gastrointestinal bleeding episode	1 year
Interventions	Number of endoscopic, radiological, and surgical interventions for bleeding treatment within the hospital stay caused by the gastrointestinal bleeding episode

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients were retrospectively recruited if they suffered an episode of a gastrointestinal bleeding and factor XIII was measured.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoph Hoegenauer, Prof.	Medical University of Graz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Graz		Graz	Styria	8036	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006471	Gastrointestinal Hemorrhage

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005176	Factor XIII

Ancestor Terms

ID	Term
D004792	Enzyme Precursors
D045762	Enzymes and Coenzymes
D001779	Blood Coagulation Factors
D001798	Blood Proteins

Browse Leaves

Not provided

Browse Branches

Not provided