Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy

Bariatric Surgery Clinical Trial

Official title:

Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06038981
• Other study ID #: TXA_SG
• Status: Completed
• Phase: N/A
• Start date: July 4, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: September 2023
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Enhanced recovery after bariatric surgery imposes a significant reduction in length of hospital stay. However beneficial for the overall recovery it reduces the hospital observation time. after a laparoscopic surgery during which one of the longest resection line in surgery or anastomosis are created. Therefore, discovering possible safe and effective ways of pharmacologically reducing surgical blood loss and reducing the risk of postoperative bleeding would be an invaluable addition to the protocol. The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation.

Description:

Aim:

To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeriessleeve gastrectomy operation.

Material and methods:

A single-blind randomized clinical trial in the high-volume bariatric center of excellence.

Patients undergoing highly standardized bariatric procedures, meeting the inclusion and exclusion criteria were included in the study, sample size determined by power study evaluation.

Randomization scheme was a weekly surgery schedule. Patients were randomized to 2 groups: TXA (administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced) od CG (no tranexamic acid administration).

Patients were evaluated on the postoperative day 1 by standard lab tests included in the center's protocol, additionally measuring the volume of drainage and heamoglobin concentration in the drainage sample.

1-month follow-up observation involving interviewing, examining and conducting lab tests of the study group was provided to determine the safety profile and possible occurrence of TXA complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant were adults qualified for bariatric procedure

Exclusion Criteria:

• Primary (pre-operative) exclusion criteria were as follows:

• Usage of anticoagulative agents in the perioperative period including:

• Indirect thrombin inhibitors (Fondaparinux, UFH, LMWH in therapeutic dosing)

• Direct inhibitors of factor Xa (NOAC)

• Direct thrombin inhibitors (Dabigatran)

• Vitamin K Antagonists (VKA: acenokumarol, warfarin)

• Platelet aggregation inhibitors (excluding ASA in dosing 75mg per day)

• P2Y12 receptor inhibitors

• Prior diagnosis of congenital or acquired blood coagulation disorders

• Diagnosed allergic reactions to TXA in medical history

• Chronic Kidney Disease in stage G3 or higher

• Chronic hemodialysis

• Haematuria in medical history

• Seizures in medical history

To achieve the most homogenous group of patients and to reduce possible bias due to additional interventions occurring during the operation - further, postoperative exclusion criteria were introduced:

Performed operation other than laparoscopic sleeve gastrectomy (LSG) Necessity of TXA administration in the postoperative period Additional, supplementary heamostatic materials and methods were used during the operation - deviation from the standard operation protocol such as: use of oxidized regenerative cellulose (ORC), cyanoacrylate laparoscopic bioglue (IfabondÒ, Peters Surgical), staple-line reinforcement.

Related Conditions & MeSH terms

• Bariatric Surgery
• Blood Loss, Surgical
• Hemorrhage
• Hemorrhage, Surgical
• Tranexamic Acid

Intervention

Drug:
• Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced
The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation. To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeries (sleeve gastrectomy operation)

Locations

Country	Name	City	State
Poland	Medical University of Gdansk	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss.	Patients were evaluated on the postoperative day 1 by standard lab tests included in the center's protocol, additionally measuring the volume of drainage and heamoglobin concentration in the drainage sample.	First postoperative day.
Secondary	TXA complications.	1-month follow-up observation involving interviewing, examining and conducting lab tests of the study group was provided to determine the safety profile and possible occurrence of TXA complications.	One month.