Gastro Intestinal BleedingNCT05933135
Factor XIII Activity in Gastrointestinal Bleedings
An observational study of Gastro Intestinal Bleeding, run by Medical University of Graz at 1 site in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastro Intestinal Bleeding
- What is being tested?
- Factor XIII Injection
- Type of treatment
- Injection or infusion
- How many people
- 97 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jan 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were retrospectively recruited if they suffered an episode of a gastrointestinal bleeding and factor XIII was measured.
Who may be able to join
- Age over 18 years
- Confirmed diagnosis of gastrointestinal bleeding
- Assessment of factor XIII activity during the gastrointestinal bleeding episode
Who cannot join
- Age under 18 years
- Diagnosis of hemophilia A or B or other congenital coagulation disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings
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.
- Conditions
- Gastro Intestinal Bleeding
- Being tested
- Factor XIII Injection
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factor XIII InjectionDrug
Patients could have had an Factor XIII Injection in clinical routine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Factor XIII Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red cell concentrates
Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode
Measured: 1 year
Secondary outcomes (3)
Hospitalization
Length of the hospital stay caused by the gastrointestinal bleeding episode
Measured: 1 year
Interventions
Number of endoscopic, radiological, and surgical interventions for bleeding treatment within the hospital stay caused by the gastrointestinal bleeding episode
Measured: 1 year
Mortality
In hospital-mortality during the hospital stay caused by the gastrointestinal bleeding episode
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start8 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Intestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Hoegenauer, Prof., Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933135
- Sponsor's protocol ID
- EK 33-123 ex 20/21
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings
- ClinicalTrials.gov ID
- NCT05933135
- Acronym / sponsor ID
- EK 33-123 ex 20/21
- Conditions
- Gastro Intestinal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal factor XIII acitivity | – | –Patients with GI bleeding and normal factor XIII activity |
| Reduced factor XIII activity | – | Drug: Factor XIII InjectionPatients with GI bleeding and reduced factor XIII activity |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were retrospectively recruited if they suffered an episode of a gastrointestinal bleeding and factor XIII was measured.
Key inclusion criteria (3 listed)
- Age over 18 years
- Confirmed diagnosis of gastrointestinal bleeding
- Assessment of factor XIII activity during the gastrointestinal bleeding episode
Key exclusion criteria (2 listed)
- Age under 18 years
- Diagnosis of hemophilia A or B or other congenital coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Factor XIII InjectionPatients could have had an Factor XIII Injection in clinical routine | Drug | Reduced factor XIII activity |
Primary outcome
Red cell concentrates
Time frame: 1 year
Number of red cell concentrates transfused during the hospital stay caused by the gastrointestinal bleeding episode
3 secondary outcomes
Hospitalization
Time frame: 1 year
Interventions
Time frame: 1 year
Mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Hoegenauer, Prof. principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Intestinal Bleeding, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red cell concentrates (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.