Intravenous Tranexamic Acid (TXA)

Ain Shams University

Status: Not yet enrolling

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

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT07192640

KACS, KSA

KASC, KSA (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

128 participants in 2 patient groups

tranexamic group

Active Comparator group

Description:

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

Treatment:

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 group

Description:

After induction of anaesthesia tranexamic acid will not be administered