NCT05696951

Brief Summary

The effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in bariatric surgery and in early postoperative bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

January 8, 2023

Last Update Submit

January 20, 2023

Conditions

Tranexamic Acid Adverse Reaction

Keywords

tranexamic acidSleeve gastrectomyPostoperative bleeding

Outcome Measures

Primary Outcomes (1)

  • effect on bleeding in the first one hours postoperatively

    postoperative bleeding

    postoperative 1st hours

Secondary Outcomes (1)

  • effect on bleeding in the first 24 hours postoperatively

    postoperative 24st hours

Study Arms (3)

The effectiveness of Tranexamic acid use of sleeve gastrectomy

ACTIVE COMPARATOR

In this study, it was determined which treatment package would be received by opening the closed envelopes of patients who had at least one point or more bleeding during the operation and had hemostasis with clips. In the intervention group, at the end of the surgery, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) saline.

Other: Transamine 200mg iv

Plasebo grup

PLACEBO COMPARATOR

The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.

Other: Transamine 200mg iv

Sham grup

ACTIVE COMPARATOR

Patients with no bleeding to be treated were not enveloped and were excluded from the intervention or placebo group.

Other: Transamine 200mg iv

Interventions

Transamine 200mg ivOTHER

In the intervention group, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes at the end of the surgery. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) SF. The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.

Plasebo grupSham grupThe effectiveness of Tranexamic acid use of sleeve gastrectomy

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18 to 65 years with an American Association of Anesthesiologists (ASA) physical condition score II or III
  • undergoing bariatric surgery and LSG

You may not qualify if:

  • history of thromboembolic disease or severe comorbidity (ASA IV or more)
  • platelet antiaggregants or anticoagulants
  • active intravascular coagulation carriers
  • acute occlusive vasculopathy
  • hypersensitivity to the components of the TXA formula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göztepe Prof. Dr. Suleyman Yalcin City Hospital

Kadıköy, Istanbul, 34732, Turkey (Türkiye)

Location

Related Publications (1)

  • Sermet M, Ozsoy MS. Effect of Tranexamic Acid on Postoperative Bleeding in Sleeve Gastrectomy: a Randomized Trial. Obes Surg. 2023 Dec;33(12):3962-3970. doi: 10.1007/s11695-023-06902-x. Epub 2023 Oct 19.

    PMID: 37857939DERIVED

MeSH Terms

Conditions

Postoperative Hemorrhage

Interventions

Tranylcypromine

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • medeni şermet, 1

    Goztepe Prof Dr Suleyman Yalcın City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Medical doctor

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 25, 2023

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 2, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)