HaemorrhagePhase 4NCT07187258
the Use of Tranexamic Acid to Prevent the Bleeding in Bariatric Surgery
A Phase 4 study testing tranexamic acid (1 g diluted in 100 mL of 0.9% saline in people with Haemorrhage and Bariatric Surgery Candidate, run by Cairo University at 1 site in Egypt.
Trial summary
Our study aims at evaluating the role of tranexamic acid in bariatric surgery since, The effect of conservative therapy using tranexamic acid for postoperative hemorrhage after bariatric surgery is still very much a novel technique. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Haemorrhage, Bariatric Surgery Candidate
- What is being tested?
- tranexamic acid (1 g diluted in 100 mL of 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Jul 2025
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-60 years were eligible if they had a body mass index (BMI) ≥ 35 kg/m², or ≥ 30 kg/m² with at least one obesity-related diseases(type 2 diabetes, hypertension, or obstructive sleep apnea).
Who cannot join
- Patients were excluded if they had a known coagulopathy or platelet disorder, a history of venous thromboembolism, myocardial infarction, or cerebrovascular accident, or if they on anticoagulant or antiplatelet therapy within ten days before surgery. Additional exclusion criteria included prior bariatric or major upper abdominal surgery, allergy or hypersensitivity to tranexamic acid, chronic kidney disease (stage 4-5), significant hepatic impairment, pregnancy or lactation.
- Patient with alzheimer disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Use of Tranexamic Acid in Preventing Intraoperative and Postoperative Hemorrahge in Bariatric Surgery
Our study aims at evaluating the role of tranexamic acid in bariatric surgery since, The effect of conservative therapy using tranexamic acid for postoperative hemorrhage after bariatric surgery is still very much a novel technique. However,Intravenous tranexamic acid at the time of laparoscopic sleeve gastrectomy is associated with a significant reduction of post-operative bleeding with no observed differences in thromboembolic events or mortality.
Read the detailed description
Participants were randomized in a 1:1 ratio to receive tranexamic acid or placebo using a computer-generated block randomization sequence (block size = 4) prepared by an independent pharmacist. Allocation concealment was maintained with sequentially numbered, opaque, sealed envelopes. The pharmacist also prepared indistinguishable infusion bags containing either tranexamic acid (1 g diluted in 100 mL of 0.9% saline) or placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute. Blinding was maintained for patients, anesthesiologists, scrub nurses, and all postoperative assessors, while the operating surgeon was necessarily unblinded, becoming aware of allocation only once the envelope was opened in the operating room. All analyses were performed according to the intention-to-treat principle.
- Conditions
- Haemorrhage, Bariatric Surgery Candidate
- Being tested
- tranexamic acid (1 g diluted in 100 mL of 0.9% saline, placebo (100 mL of 0.9% saline).
- Keywords
- bleeding - sleeve gastrectomy (SG)
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acid (1 g diluted in 100 mL of 0.9% salineDrug
Also called TXA
The pharmacist also prepared indistinguishable infusion bags containing tranexamic acid (1 g diluted in 100 mL of 0.9% saline) . The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute
placebo (100 mL of 0.9% saline).Drug
Also called Inert saline
The pharmacist also prepared indistinguishable infusion bags containing placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute
| Study group | Role | What they receive |
|---|---|---|
| tranexamic acid (1 g diluted in 100 mL of 0.9% saline | Experimental | TXA 1gm dilutedin 100 ml of .9% normal saline Will be given as IV infusion Before anasthesia Receives: Drug: tranexamic acid (1 g diluted in 100 mL of 0.9% saline |
| placebo (100 mL of 0.9% saline). | Placebo comparator | Placebo diluted in 100 ml of .9% normal saline Will be given as IV infusion Before anasthesia Receives: Drug: placebo (100 mL of 0.9% saline). |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative estimated blood loss (EBL
Volume of blood loss in cm centimeter cubic
Measured: 10 DAYS
BLEEDING IN SLEEVE GASTRECTOMY
Volume of blood loss in cubic centimeter
Measured: 10 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jul 2024
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HaemorrhageStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized in a 1:1 ratio to receive tranexamic acid or placebo using a computer-generated block randomization sequence (block size = 4) prepared by an independent pharmacist. Allocation concealment was maintained with sequentially numbered, opaque, sealed envelopes. The pharmacist also prepared indistinguishable infusion bags containing either tranexamic acid (1 g diluted in 100 mL of 0.9% saline) or placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute. Blinding was maintained for patients, anesthesiologists, scrub nurses, and all postoperative assessors, while the operating surgeon was necessarily unblinded, becoming aware of allocation only once the envelope was opened in the operating room. All analyses were performed according to the intention-to-treat principle.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Elshwadfy Nageeb, Cairo University
- Investigators
- Mohammed Elshwadfy, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187258
- Sponsor's protocol ID
- MS-204-2024
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2025
- Last updated
- 22 Sep 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 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Use of Tranexamic Acid in Preventing Intraoperative and Postoperative Hemorrahge in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07187258
- Acronym / sponsor ID
- MS-204-2024
- Conditions
- Haemorrhage, Bariatric Surgery Candidate
- Keywords
- bleeding - sleeve gastrectomy (SG)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 22 Sep 2025 (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.
Our study aims at evaluating the role of tranexamic acid in bariatric surgery since, The effect of conservative therapy using tranexamic acid for postoperative hemorrhage after bariatric surgery is still very much a novel technique. However,Intravenous tranexamic acid at the time of laparoscopic sleeve gastrectomy is associated with a significant reduction of post-operative bleeding with no observed differences in thromboembolic events or mortality.
Detailed description
Participants were randomized in a 1:1 ratio to receive tranexamic acid or placebo using a computer-generated block randomization sequence (block size = 4) prepared by an independent pharmacist. Allocation concealment was maintained with sequentially numbered, opaque, sealed envelopes. The pharmacist also prepared indistinguishable infusion bags containing either tranexamic acid (1 g diluted in 100 mL of 0.9% saline) or placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute. Blinding was maintained for patients, anesthesiologists, scrub nurses, and all postoperative assessors, while the operating surgeon was necessarily unblinded, becoming aware of allocation only once the envelope was opened in the operating room. All analyses were performed according to the intention-to-treat principle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized in a 1:1 ratio to receive tranexamic acid or placebo using a computer-generated block randomization sequence (block size = 4) prepared by an independent pharmacist. Allocation concealment was maintained with sequentially numbered, opaque, sealed envelopes. The pharmacist also prepared indistinguishable infusion bags containing either tranexamic acid (1 g diluted in 100 mL of 0.9% saline) or placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute. Blinding was maintained for patients, anesthesiologists, scrub nurses, and all postoperative assessors, while the operating surgeon was necessarily unblinded, becoming aware of allocation only once the envelope was opened in the operating room. All analyses were performed according to the intention-to-treat principle.
| Arm | Type | Receives |
|---|---|---|
| tranexamic acid (1 g diluted in 100 mL of 0.9% saline | Experimental | Drug: tranexamic acid (1 g diluted in 100 mL of 0.9% salineTXA 1gm dilutedin 100 ml of .9% normal saline Will be given as IV infusion Before anasthesia |
| placebo (100 mL of 0.9% saline). | Placebo comparator | Drug: placebo (100 mL of 0.9% saline).Placebo diluted in 100 ml of .9% normal saline Will be given as IV infusion Before anasthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-60 years were eligible if they had a body mass index (BMI) ≥ 35 kg/m², or ≥ 30 kg/m² with at least one obesity-related diseases(type 2 diabetes, hypertension, or obstructive sleep apnea).
Key exclusion criteria (2 listed)
- Patients were excluded if they had a known coagulopathy or platelet disorder, a history of venous thromboembolism, myocardial infarction, or cerebrovascular accident, or if they on anticoagulant or antiplatelet therapy within ten days before surgery. Additional exclusion criteria included prior bariatric or major upper abdominal surgery, allergy or hypersensitivity to tranexamic acid, chronic kidney disease (stage 4-5), significant hepatic impairment, pregnancy or lactation.
- Patient with alzheimer disease
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 |
|---|---|---|
| tranexamic acid (1 g diluted in 100 mL of 0.9% salineAlso: TXAThe pharmacist also prepared indistinguishable infusion bags containing tranexamic acid (1 g diluted in 100 mL of 0.9% saline) . The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute | Drug | tranexamic acid (1 g diluted in 100 mL of 0.9% saline |
| placebo (100 mL of 0.9% saline).Also: Inert salineThe pharmacist also prepared indistinguishable infusion bags containing placebo (100 mL of 0.9% saline). The infusion was administered intravenously over 10-15 minutes immediately after induction of anesthesia and before skin incision, at a maximum rate of 100 mg per minute | Drug | placebo (100 mL of 0.9% saline). |
Primary outcome
intraoperative estimated blood loss (EBL
Time frame: 10 DAYS
Volume of blood loss in cm centimeter cubic
BLEEDING IN SLEEVE GASTRECTOMY
Time frame: 10 DAYS
Volume of blood loss in cubic centimeter
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 22 Sep 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.
Mohammed Elshwadfy, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tranexamic acid (1 g diluted in 100 mL of 0.9% saline in people with Haemorrhage and Bariatric Surgery Candidate, run by Cairo University at 1 site in Egypt.
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 1 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 22 Sep 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
intraoperative estimated blood loss (EBL (time frame: 10 DAYS). The study lists 2 primary outcomes in all. 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 22 Sep 2025.