NCT03044041

Brief Summary

The purpose of this study is to compare blood loss between using low dose (500 mg) and high dose (3 g) topical intra-articular tranexamic acid after total knee arthroplasty in double-blind RCT

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2016

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, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

January 29, 2017

Last Update Submit

January 27, 2018

Conditions

Blood Loss, Surgical

Keywords

Blood lossTranexamic acidTotal knee arthroplastyTopical administration

Outcome Measures

Primary Outcomes (1)

  • Total blood loss

    Blood loos that calculated from Haemoglobin drop at 72 hours after surgery

    72 hours after TKA

Secondary Outcomes (5)

  • Blood transfusion

    0-72 hours after surgery

  • Rate of participants with thromboembolism

    At 72 hours and 2 weeks after surgery

  • Rate of participants with infection

    0-3 months after surgery

  • Knee ROM

    At 2, 6 weeks after surgery

  • Functional score

    At 6 weeks after surgery

Study Arms (2)

Low dose

EXPERIMENTAL

single dose of intra-articular Tranexamic acid 500 miligrams

Drug: Tranexamic Acid

High dose

ACTIVE COMPARATOR

Single dose of intra-articular Tranexamic acid 3 grams

Drug: Tranexamic Acid

Interventions

Tranexamic AcidDRUG

IA (intra-articular) tranexamic acid after capsule closure

High doseLow dose

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Osteoarthritic knee who underwent primary total knee arthroplasty

You may not qualify if:

  • Abnormal coagulation or bleeding disorder
  • Allergy to tranexamic acid
  • History of thromboembolism or ischemic heart disease or cerebrovascular accident
  • chronic kidney disease stage 3-4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University

Klong Luang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Blood Loss, SurgicalHemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

January 29, 2017

First Posted

February 6, 2017

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

TH(1)