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

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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery; Hemorrhage, Surgical; Tranexamic Acid
• Intervention / Treatment: Drug: Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland
    • Medical University of Gdansk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Medical University of Gdansk

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: September 8, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: bariatric surgery; Hemorrhage; Tranexamic Acid
• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TXA_SG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Study Protocol and SAP will be available soon online.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No