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

• ClinicalTrials.gov Identifier: NCT06038981
• Recruitment Status: Completed
• First Posted: September 15, 2023
• Last Update Posted: September 22, 2023
• Sponsor: Medical University of Gdansk
• Information provided by (Responsible Party): Medical University of Gdansk

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hemorrhage, Surgical; Bariatric Surgery; Tranexamic Acid	Drug: Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial
• Actual Study Start Date: July 4, 2022
• Actual Primary Completion Date: June 28, 2023
• Actual Study Completion Date: June 28, 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control Group (CG).; no tranexamic acid administration.
Experimental: TXA group.; Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced.	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)

Outcome Measures

Primary Outcome Measures :

1. Blood loss. [ Time Frame: First postoperative day. ]
   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.

Secondary Outcome Measures :

1. TXA complications. [ Time Frame: One month. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Poland

Medical University of Gdańsk

Gdańsk, Poland

Sponsors and Collaborators

Medical University of Gdansk

More Information

• Responsible Party: Medical University of Gdansk
• ClinicalTrials.gov Identifier: NCT06038981
• Other Study ID Numbers: TXA_SG
• First Posted: September 15, 2023
• Last Update Posted: September 22, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Study Protocol and SAP will be available soon online.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medical University of Gdansk:

bariatric surgery; Hemorrhage; Tranexamic Acid

Additional relevant MeSH terms:

Hemorrhage; Blood Loss, Surgical; Pathologic Processes; Intraoperative Complications; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants