Intravenous Tranexamic Acid

Not Applicable

Not yet recruiting

• Conditions: Obese Patients; Obese Patients With Bariatric Surgery; Bleeding
• Interventions: 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

• Registration Number: NCT07192640
• Lead Sponsor: Ain Shams University

Brief 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 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 Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Study Start: 2025-10-15
• Primary Completion: 2026-02-15
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• High-risk patients, with obesity, BMI more than 45,
• Patients with Preexisting cardiovascular condition, Hypertension, diabetes, or coagulation disorders, thyroid dysfunction and pulmonary disorders.

Exclusion Criteria

• patients with active thromboembolic disorders.
• Patients with preexisting renal dysfunction,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tranexamic group	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	After induction of anesthesia tranexamic acid will be administered at the start of surgery to reduce intraoperative bleeding. loading dose of 10 mg/kg

Primary Outcome Measures

Name	Time	Method
Intraoperative blood Loss	"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

Secondary Outcome Measures

Name	Time	Method
postoperative risk of thromboembolism, infections, delayed wound healing, or longer hospital stays	pre-intervention/surgery""Postoperative "up to 1 week"	The patients will be followed up for one week for possible incidence of side effects

Trial Locations

Locations (1)

King Salman Specialist Hospital, Hail, KSA; 🇸🇦 Hail, Saudi Arabia

King Salman Specialist Hospital, Hail, KSA

🇸🇦Hail, Saudi Arabia

Saad Abdullah Alrasheedi, Chairman, Institutional Board

Contact

966162362222

IRB-HAIL@MOH.GOV.SA