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

Primary Purpose

Hemorrhage, Surgical, Bariatric Surgery, Tranexamic Acid

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage, Surgical focused on measuring bariatric surgery, Hemorrhage, Tranexamic Acid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of Gdańsk

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group (CG).

TXA group.

Arm Description

no tranexamic acid administration.

Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 8, 2023
Last Updated
September 20, 2023
Sponsor
Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT06038981
Brief Title
Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy
Official Title
Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
June 28, 2023 (Actual)
Study Completion Date
June 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Gdansk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Surgical, Bariatric Surgery, Tranexamic Acid
Keywords
bariatric surgery, Hemorrhage, Tranexamic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (CG).
Arm Type
No Intervention
Arm Description
no tranexamic acid administration.
Arm Title
TXA group.
Arm Type
Experimental
Arm Description
Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced.
Intervention Type
Drug
Intervention Name(s)
Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced
Intervention Description
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)
Primary Outcome Measure Information:
Title
Blood loss.
Description
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.
Time Frame
First postoperative day.
Secondary Outcome Measure Information:
Title
TXA complications.
Description
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.
Time Frame
One month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Medical University of Gdańsk
City
Gdańsk
Country
Poland

12. IPD Sharing Statement

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

Learn more about this trial

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

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