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Not yet recruiting NCT07192640

Intravenous Tranexamic Acid

No phase Interventional Obese Patients Obese Patients With Bariatric Surgery Bleeding

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Obese Patients, Obese Patients With Bariatric Surgery, Bleeding. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Saudi Arabia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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
    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 outcome measures

  • Intraoperative blood Loss [Time frame: "Perioperative"]
Secondary outcome measures (1)
  • postoperative risk of thromboembolism, infections, delayed wound healing, or longer hospital stays [Time frame: pre-intervention/surgery""Postoperative "up to 1 week"]

Eligibility criteria

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Saudi Arabia · 1 center
  • King Salman Specialist Hospital, Hail, KSA — Ha'il

Identifiers

NCT: NCT07192640 · KACS, KSA · KASC, KSA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗