Bleeding, Obese Patients, Obese Patients With Bariatric Surgery
Conditions
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.
Interventions
DRUGAfter 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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| postoperative risk of thromboembolism, infections, delayed wound healing, or longer hospital stays | pre-intervention/surgeryPostoperative up to 1 week | The patients will be followed up for one week for possible incidence of side effects |
Countries
Saudi Arabia
Contacts
Primary ContactSABAH NAGUIB AYOUB, Medical Doctorate
Backup ContactINSTITUTIONAL NAGUIB CHAIRMAN, Medical Doctorate
Outcome results
None listed