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NCT Number: NCT07192640

Intravenous Tranexamic Acid

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.

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Key information

Conditions

Obese Patients Bleeding Hemorrhage Obese Patients With Bariatric Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. postoperative risk of thromboembolism, infections, delayed wound healing, or longer hospital stays

    Time frame: pre-intervention/surgery""Postoperative "up to 1 week"

    The patients will be followed up for one week for possible incidence of side effects

Study contacts

Contact information is provided by the study sponsor or research team.

INSTITUTIONAL NAGUIB CHAIRMAN, Medical Doctorate

CONTACT

[email protected]

+20165582115

SABAH NAGUIB AYOUB, Medical Doctorate

CONTACT

[email protected]

+966563887242

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

PERIOPERATIVE USE OF INTRAVENOUS TRANEXAMIC ACID FOR HIGH BMI PATIENTS GOING THROUGH BARIATRIC SURGERIES

Acronym: TXA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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