Gastrointestinal HemorrhageNCT07822958
Gastrointestinal Bleeding in Critically Ill Patients
An observational study of Gastrointestinal Hemorrhage and Critical Illness, run by Assiut University.
Trial summary
This prospective cohort study aims to determine the prevalence of gastrointestinal bleeding among critically ill patients admitted to intensive care units, identify independent risk factors, and describe clinical outcomes including ICU length of stay, transfusion requirements, and mortality at Assiut University… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage, Critical Illness
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2026to 1 Jun 2028
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.
Who may be able to join
- - Age 18 years or older
- Admission to the intensive care unit
- Onset of gastrointestinal bleeding after ≥24 hours of ICU admission (to distinguish ICU-acquired bleeding)
- Overt gastrointestinal bleeding (hematemesis, melena, hematochezia, or bloody nasogastric aspirate) and/or occult bleeding confirmed by fecal occult blood test or endoscopy
- Written informed consent (from patient or legal representative)
Who cannot join
- - Age less than 18 years
- Pregnancy
- Gastrointestinal bleeding clearly due to trauma or recent gastrointestinal surgery/procedure
- Known bleeding disorder unrelated to critical illness
- Recent receipt of peptic ulcer prophylaxis (two or more doses)
- Incomplete medical records or loss to follow-up
- Refusal to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gastrointestinal Bleeding in Critically Ill Patients: Prevalence, Risk Factors, and Clinical Outcomes
This prospective cohort study aims to determine the prevalence of gastrointestinal bleeding among critically ill patients admitted to intensive care units, identify independent risk factors, and describe clinical outcomes including ICU length of stay, transfusion requirements, and mortality at Assiut University Hospitals.
Read the detailed description
Gastrointestinal bleeding is a serious complication in critically ill patients and is associated with increased morbidity and mortality. This prospective observational cohort study will include adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.
Patients will be followed during their ICU stay for the occurrence of clinically important gastrointestinal bleeding (overt or occult) occurring ≥24 hours after admission. Clinical, laboratory, and treatment-related data will be collected to identify independent risk factors and to assess associated clinical outcomes.
- Conditions
- Gastrointestinal Hemorrhage, Critical Illness
- Keywords
- Mortality, Gastrointestinal bleeding, Critically ill, ICU, Risk factors, Assiut
- Medical subject headings
- Gastrointestinal Hemorrhage, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: Critically ill adult patients admitted to ICU | Adult patients admitted to the intensive care units who will be followed for the occurrence of ICU-acquired gastrointestinal bleeding and its associated risk factors and outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically important ICU-acquired gastrointestinal bleeding
Proportion of critically ill patients who develop clinically important gastrointestinal bleeding (overt bleeding with hemodynamic compromise or significant hemoglobin drop, or occult bleeding confirmed by fecal occult blood test or endoscopy) occurring 24 hours or more after ICU admission.
Measured: Up to 30 days
Secondary outcomes (5)
Independent risk factors for gastrointestinal bleeding
Odds ratios of clinical, laboratory, and treatment-related factors for the occurrence of clinically important gastrointestinal bleeding using multivariable logistic regression analysis.
Measured: Up to 30 days
ICU length of stay
Duration of intensive care unit stay in days.
Measured: Up to 30 days
Blood transfusion requirement
Number of units of packed red blood cells transfused during the ICU stay.
Measured: Up to 30 days
ICU mortality
Proportion of patients who die during the ICU stay.
Measured: Up to 30 days
Need for endoscopic or surgical intervention
Proportion of patients requiring endoscopic therapy or surgical intervention for gastrointestinal bleeding.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 310 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidy Mohamed Mahmoud, Assiut University
- Investigators
- Ahmed M Ashmawy, prof, Study chair, Internal Medicine Department, Assiut University HospitalsAbdelHamid M Aly, Prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822958
- Sponsor's protocol ID
- GIB-ICU-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Bleeding in Critically Ill Patients: Prevalence, Risk Factors, and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07822958
- Acronym / sponsor ID
- GIB-ICU-Assiut-2026
- Conditions
- Gastrointestinal Hemorrhage, Critical Illness
- Keywords
- Mortality, Gastrointestinal bleeding, Critically ill, ICU, Risk factors, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 16 Sep 2026 (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.
This prospective cohort study aims to determine the prevalence of gastrointestinal bleeding among critically ill patients admitted to intensive care units, identify independent risk factors, and describe clinical outcomes including ICU length of stay, transfusion requirements, and mortality at Assiut University Hospitals.
Detailed description
Gastrointestinal bleeding is a serious complication in critically ill patients and is associated with increased morbidity and mortality. This prospective observational cohort study will include adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.
Patients will be followed during their ICU stay for the occurrence of clinically important gastrointestinal bleeding (overt or occult) occurring ≥24 hours after admission. Clinical, laboratory, and treatment-related data will be collected to identify independent risk factors and to assess associated clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: Critically ill adult patients admitted to ICU | – | –Adult patients admitted to the intensive care units who will be followed for the occurrence of ICU-acquired gastrointestinal bleeding and its associated risk factors and outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.
Key inclusion criteria (5 listed)
- - Age 18 years or older
- Admission to the intensive care unit
- Onset of gastrointestinal bleeding after ≥24 hours of ICU admission (to distinguish ICU-acquired bleeding)
- Overt gastrointestinal bleeding (hematemesis, melena, hematochezia, or bloody nasogastric aspirate) and/or occult bleeding confirmed by fecal occult blood test or endoscopy
- Written informed consent (from patient or legal representative)
Key exclusion criteria (7 listed)
- - Age less than 18 years
- Pregnancy
- Gastrointestinal bleeding clearly due to trauma or recent gastrointestinal surgery/procedure
- Known bleeding disorder unrelated to critical illness
- Recent receipt of peptic ulcer prophylaxis (two or more doses)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of clinically important ICU-acquired gastrointestinal bleeding
Time frame: Up to 30 days
Proportion of critically ill patients who develop clinically important gastrointestinal bleeding (overt bleeding with hemodynamic compromise or significant hemoglobin drop, or occult bleeding confirmed by fecal occult blood test or endoscopy) occurring 24 hours or more after ICU admission.
5 secondary outcomes
Independent risk factors for gastrointestinal bleeding
Time frame: Up to 30 days
ICU length of stay
Time frame: Up to 30 days
Blood transfusion requirement
Time frame: Up to 30 days
ICU mortality
Time frame: Up to 30 days
Need for endoscopic or surgical intervention
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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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.
Ahmed M Ashmawy, prof study chair
Internal Medicine Department, Assiut University Hospitals
AbdelHamid M Aly, Prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Hemorrhage and Critical Illness, run by Assiut University.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haidy M Mohamed, Resident (0 11 50184210, Heidi.18313235@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically important ICU-acquired gastrointestinal bleeding (time frame: Up to 30 days). 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 16 Sep 2026.