Obese PatientsTXANCT07192640
Intravenous Tranexamic Acid
A study testing After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatr in people with Obese Patients and Obese Patients With Bariatric Surgery, run by Ain Shams University at 1 site in Saudi Arabia.
Trial summary
Tranexamic acid is a promising option for minimizing blood loss in high-risk bariatric surgery patients, particularly in those with obesity, diabetes, and other comorbidities. When used appropriately, TXA can reduce the need for blood transfusions, maintain hemodynamic stability, and lower the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese Patients, Obese Patients With Bariatric Surgery, Bleeding
- What is being tested?
- After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatr
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Oct 2025to 30 Mar 2026
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- High-risk patients, with obesity, BMI more than 45,
- Patients with Preexisting cardiovascular condition, Hypertension, diabetes, or coagulation disorders, thyroid dysfunction and pulmonary disorders.
Who cannot join
- patients with active thromboembolic disorders.
- Patients with preexisting renal dysfunction,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site
King Salman Specialist Hospital, Hail, KSA
Ha'il, 6539307
Saad Abdullah Alrasheedi, Chairman, Institutional Board, 966162362222, IRB-HAIL@MOH.GOV.SA
IRB-HAIL@MOH.GOV.SA
About this study
Official title: PERIOPERATIVE USE OF INTRAVENOUS TRANEXAMIC ACID FOR HIGH BMI PATIENTS GOING THROUGH BARIATRIC SURGERIES
Tranexamic acid is a promising option for minimizing blood loss in high-risk bariatric surgery patients, particularly in those with obesity, diabetes, and other comorbidities. When used appropriately, TXA can reduce the need for blood transfusions, maintain hemodynamic stability, and lower the incidence of complications related to blood loss.
Read the detailed description
The impact of TXA in high-risk individuals undergoing bariatric surgery is of increasing interest, especially given the inherent risks of bleeding and complications associated with these procedures. Bariatric surgery, particularly procedures like Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy, carries a risk of significant blood loss, which may be exacerbated in patients who are morbid obese or have underlying comorbid conditions such as hypertension, diabetes, or coagulation disorders.
TXA can effectively reduce intraoperative and postoperative blood loss by stabilizing fibrin clots, which is critical in preventing the need for transfusions and reducing surgical complications. A few studies have explored the use of TXA in bariatric surgery because of the fear of associated increased incidence of embolic complications.
- Being tested
- After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatr
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatrDrug
This intervention will be applied for High-risk patients, with obesity, BMI more than 45, Preexisting cardiovascular condition, Hypertension, diabetes, or coagulation disorders, thyroid dysfunction and pulmonary disorders.
| Study group | Role | What they receive |
|---|---|---|
| tranexamic group | Active comparator | After induction of anesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg Receives: Drug: After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatr |
| control group | No intervention | After induction of anaesthesia tranexamic acid will not be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood Loss
Intraoperative and postoperative Blood Loss will be calculated in the suction and wet gauzes by blood and the need for blood transfusion will be recorded
Measured: "Perioperative"
Secondary outcomes (1)
postoperative risk of thromboembolism, infections, delayed wound healing, or longer hospital stays
The patients will be followed up for one week for possible incidence of side effects
Measured: pre-intervention/surgery""Postoperative "up to 1 week"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese PatientsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatric surgery Control group of high BMI bariatrics patients will not receive TXA but will be operated by the same surgery team and homeostasis steps.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabah Nageeb, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192640
- Sponsor's protocol ID
- KACS, KSA
- Other IDs
- KASC, KSA
- Acronym
- TXA
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERIOPERATIVE USE OF INTRAVENOUS TRANEXAMIC ACID FOR HIGH BMI PATIENTS GOING THROUGH BARIATRIC SURGERIES
- ClinicalTrials.gov ID
- NCT07192640
- Acronym / sponsor ID
- TXA / KACS, KSA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 25 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.
Tranexamic acid is a promising option for minimizing blood loss in high-risk bariatric surgery patients, particularly in those with obesity, diabetes, and other comorbidities. When used appropriately, TXA can reduce the need for blood transfusions, maintain hemodynamic stability, and lower the incidence of complications related to blood loss.
Detailed description
The impact of TXA in high-risk individuals undergoing bariatric surgery is of increasing interest, especially given the inherent risks of bleeding and complications associated with these procedures. Bariatric surgery, particularly procedures like Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy, carries a risk of significant blood loss, which may be exacerbated in patients who are morbid obese or have underlying comorbid conditions such as hypertension, diabetes, or coagulation disorders.
TXA can effectively reduce intraoperative and postoperative blood loss by stabilizing fibrin clots, which is critical in preventing the need for transfusions and reducing surgical complications. A few studies have explored the use of TXA in bariatric surgery because of the fear of associated increased incidence of embolic complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatric surgery Control group of high BMI bariatrics patients will not receive TXA but will be operated by the same surgery team and homeostasis steps.
| Arm | Type | Receives |
|---|---|---|
| tranexamic group | Active comparator | Drug: After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatrAfter induction of anesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg |
| control group | No intervention | –After induction of anaesthesia tranexamic acid will not be administered |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- High-risk patients, with obesity, BMI more than 45,
- Patients with Preexisting cardiovascular condition, Hypertension, diabetes, or coagulation disorders, thyroid dysfunction and pulmonary disorders.
Key exclusion criteria (2 listed)
- patients with active thromboembolic disorders.
- Patients with preexisting renal dysfunction,
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 |
|---|---|---|
| After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatrThis intervention will be applied for High-risk patients, with obesity, BMI more than 45, Preexisting cardiovascular condition, Hypertension, diabetes, or coagulation disorders, thyroid dysfunction and pulmonary disorders. | Drug | tranexamic group |
Primary outcome
Intraoperative blood Loss
Time frame: "Perioperative"
Intraoperative and postoperative Blood Loss will be calculated in the suction and wet gauzes by blood and the need for blood transfusion will be recorded
1 secondary outcome
postoperative risk of thromboembolism, infections, delayed wound healing, or longer hospital stays
Time frame: pre-intervention/surgery""Postoperative "up to 1 week"
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 25 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing After induction of anaesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg for high BMI patients who are undergoing bariatr in people with Obese Patients and Obese Patients With Bariatric Surgery, run by Ain Shams University at 1 site in Saudi Arabia.
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 2 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: opening soon, as of the sponsor's last update on 25 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 Saudi Arabia. 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?
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 SABAH NAGUIB AYOUB, Medical Doctorate (+966563887242, sabah.nageeb@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood Loss (time frame: "Perioperative"). 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 Sep 2025.