Intravenous Tranexamic Acid

NCT07192640 | Not Yet Recruiting DMC

• 2 other identifiers: KACS, KSAKASC, KSA
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Patients; Obese Patients With Bariatric Surgery; Bleeding

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood Loss

  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

  "Perioperative"

Secondary Outcomes (1)

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

  pre-intervention/surgery""Postoperative "up to 1 week"

Study Arms (2)

tranexamic group

ACTIVE COMPARATOR

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

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

After induction of anaesthesia tranexamic acid will not be administered

Interventions

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.

tranexamic group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

King Salman Specialist Hospital, Hail, KSA

Hail, 6539307, Saudi Arabia

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

SABAH NAGUIB AYOUB, Medical Doctorate

CONTACT

+966563887242; sabah.nageeb@yahoo.com

INSTITUTIONAL NAGUIB CHAIRMAN, Medical Doctorate

CONTACT

+20165582115; IRB-HAIL@MOH.GOV.SA

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesia consultant

Model Details: 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.

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 25, 2025
• Study Start: October 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 30, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

SA (1)