NCT06038981

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

12 months

First QC Date

September 8, 2023

Last Update Submit

September 20, 2023

Conditions

Hemorrhage, SurgicalBariatric SurgeryTranexamic Acid

Keywords

bariatric surgeryHemorrhageTranexamic Acid

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • TXA complications.

    One month.

Study Arms (2)

Control Group (CG).

NO INTERVENTION

no tranexamic acid administration.

TXA group.

EXPERIMENTAL

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

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

Interventions

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

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)

TXA group.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant were adults qualified for bariatric procedure

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Gdańsk

Gdansk, Poland

Location

MeSH Terms

Conditions

Blood Loss, SurgicalHemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 15, 2023

Study Start

July 4, 2022

Primary Completion

June 28, 2023

Study Completion

June 28, 2023

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

PL(1)