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Not yet recruitingNCT07822958Updated Sep 16, 2026

Gastrointestinal Bleeding in Critically Ill Patients

An observational study in Gastrointestinal Hemorrhage and Critical Illness, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
310
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Gastrointestinal Hemorrhage by Assiut University — 9 open to participants now, 9 under way, 1 of them phase 3. Gastrointestinal Hemorrhage · Assiut University.

Planned enrollment
Largest of 11
310 · median 100
Started
2026
with 2 others
Observational
11 of 12
8 open now
Registered
12th of 12
by date

Among the 12 studies in Gastrointestinal Hemorrhage by Assiut University, this one has the largest planned enrollment of the 11 observational ones that give a count, is one of 3 that started in 2026, is one of 11 observational ones, and was the 12th registered.

Gastrointestinal Hemorrhage

338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.

Browse Gastrointestinal Hemorrhage studies →

Open to participants now

9 of the 12 studies in Gastrointestinal Hemorrhage by Assiut University are open now, in 1 country. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 9 open studies →

Where they have run

Who these studies take

Of the 49 Gastrointestinal Hemorrhage studies recruiting now, 39 (80%) set no upper age limit and 4 (8%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Gastrointestinal Hemorrhage
  • Critical Illness

Keywords

  • Mortality
  • Gastrointestinal bleeding
  • Critically ill
  • ICU
  • Risk factors
  • Assiut
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (≥18 years) admitted to the intensive care units of Assiut University Hospitals.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - 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 (from patient or legal representative)

Exclusion criteria

Exclusion Criteria:

  • - 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
310 participants (estimated)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 30 days

Secondary outcomes

  1. 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.

    Time frame: Up to 30 days

  2. ICU length of stay

    Duration of intensive care unit stay in days.

    Time frame: Up to 30 days

  3. Blood transfusion requirement

    Number of units of packed red blood cells transfused during the ICU stay.

    Time frame: Up to 30 days

  4. ICU mortality

    Proportion of patients who die during the ICU stay.

    Time frame: Up to 30 days

  5. Need for endoscopic or surgical intervention

    Proportion of patients requiring endoscopic therapy or surgical intervention for gastrointestinal bleeding.

    Time frame: Up to 30 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 42 non-industry observational studies under Gastrointestinal Hemorrhage, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 63. This study's planned 12 months is below that.

Counting every sponsor, half of 47 studies reached it within 36 months; a quarter within 23 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 16, 2026
StartEst.
Sep 5, 2026
Primary completionEst.
Sep 20, 2027
CompletionEst.
Jun 1, 2028
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07822958
Lead sponsor
Assiut University
Responsible party
Haidy Mohamed Mahmoud (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 16, 2026
Start date
Sep 5, 2026 (estimated)
Primary completion
Sep 20, 2027 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Haidy M Mohamed, Resident
Contact
Heidi.18313235@med.aun.edu.eg
0 11 50184210
Ahmed M Ashmawy, prof
study chair · Internal Medicine Department, Assiut University Hospitals
AbdelHamid M Aly, Prof
study chair · Internal Medicine Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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