Goal-directed vs Preemptive Tranexamic Acid Administratio... | NCT05957822

Studies
Goal-directed vs Preemptive Tranexamic Acid Administration in Non-cardiac Surgery

NCT05957822

Sponsor

Konkuk University Medical Center

Status

Unknown status

Last Update Posted

May 14, 2024Actual

Enrollment

148Estimated

Phase

Phase 4

Conditions

Arthritis Knee
Spine Fusion
Prostate Cancer
Arthritis of Hip
Hepatic Cancer

Interventions

TXA
TEG6

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 10, 2024Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Jul 7, 2023

First Submission Date that Met QC Criteria

Jul 16, 2023

First Posted Date

Jul 24, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2024

Last Update Posted Date

May 14, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Name	Class
Korea Health Industry Development Institute	OTHER_GOV
Asan Medical Center	OTHER
Soon Chun Hyang University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The present study is a multi-center randomized prospective non-inferiority trial. The study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in high-risk non-cardiac surgery. The secondary objectives include comparing the amount of bleeding, incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.

Detailed Description

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. This study's primary objective is to compare the coagulation profile upon using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based goal-directed TXA administration in non-cardiac surgery. The secondary objectives include determining the inter-group differences in hyper-fibrinolysis, during postoperative 2bleeding, thromboembolic complications, and postoperative seizures. Researchers hypothesized that goal-directed TXA administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. Researchers also expect that goal-directed TXA administration would be beneficial in lowering TXA-induced thromboembolic complications and seizure risks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

148Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TXA empirical	Active Comparator	Empirical Tranexamic acid (TXA) administration after the anesthesia induction	Drug: TXA
TXA TEG6-triggered	Experimental	When LY30≥3% or MA<54 mm in CRT of TEG6, Tranexamic acid (TXA) is administered	Drug: TXA Diagnostic Test: TEG6
TXA TEG6-non-triggered	Experimental	When LY30<3% or MA ≥ 54 mm in CRT of TEG6, Tranexamic acid (TXA) is not administered	Diagnostic Test: TEG6

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TXA	Drug	Tranexamic acid injection 8-10mg/kg	TXA TEG6-triggered TXA empirical

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRT maximal amplitude	maximal amplitude of CRT test	24 hours

Secondary Outcomes

Measure	Description	Time Frame
CK reaction time	value of r-time of CK test	24 hours
CK alpha angle	value of alpha-angle of CK test	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria patients undergoing following surgery

spinal fusion surgery with more than 2 levels
total hip arthroplasty
total knee arthroplasty
open prostatectomy
hepatectomy

Exclusion Criteria:

pregnancy
refusal of allogenic blood transfusion
taking thrombin
history of thromboembolic and familial hypercoagulability disease
recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
hypersensitive to TXA
histroy of convulsion or epilepsy
taking hemodialysis
history of Heparin-induced thrombocytopenia

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tae-Yop Kim	Contact	+82 10 8811 6942		taeyop@gmail.com
Wooseul Lee	Contact	+82 10 8805 5661		wslee.kku@gmail.com

Overall Officials

Name	Affiliation	Role
Tae-Yop Kim, MD, PhD	Konkuk University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konkuk University Medical Center	Recruiting	Seoul		143-729	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D008113	Liver Neoplasms
D006470	Hemorrhage
D013923	Thromboembolism
D012640	Seizures

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided