NCT03019198

Brief Summary

This study aims to analyze the efficacy of intravenous tranexamic acid (TXA) in patients undergoing total hip arthroplasty (THA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
256

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2013

Typical duration for phase_4

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

December 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

January 10, 2017

Last Update Submit

March 7, 2017

Conditions

Blood Loss, SurgicalTranexamic Acid Adverse ReactionHip Replacement

Keywords

Tranexamic AcidBlood lossTranfusion

Outcome Measures

Primary Outcomes (4)

  • Hemoglobin drop

    24 hours post operative

  • Hematocrit drop

    24 hours post operative

  • Blood transfusion rate

    5 days

  • Operative blood loss

    24 hours post operative

Secondary Outcomes (3)

  • Length of stay in hospital

    7 days

  • Systemic adverse events

    1 year

  • Thromboembolic efects

    1 year

Study Arms (2)

TXA

EXPERIMENTAL

Performed an intravenous bolus administration of 15 mg/kg of TXA to the volunteers after the end of the anesthesia and 15 minutes prior to skin incision.

Drug: Tranexamic Acid Injectable Solution

Control

PLACEBO COMPARATOR

This group underwent the same procedures of the TXA group, excepting the preoperative administration of the medication.

Drug: Placebo - Concentrate

Interventions

Tranexamic Acid Injectable SolutionDRUG

Intravenous 15 mg per kilogram tranexamic acid

Also known as: Lysteda, Transamin
TXA
Placebo - ConcentrateDRUG
Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive patients who need total hip replacement were included in the initial sample. There was no age limit or restriction regarding gender for admission to the study.

You may not qualify if:

  • Patients who underwent previous surgery in the same joint, evidence of joint infection, congenital or acquired coagulopathies, active intravascular coagulation, acute occlusive vasculopathy, hypersensitivity to TXA, chronic use of oral and steroid anticoagulants, history of severe or moderate allergy to plasma transfusion, chronic heart disease, malignant neoplasms and autoimmune diseases, patients who needed bone graft or underwent hip arthroplasty revision surgeries, and who did not consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Traumatologia e Ortopedia

Rio de Janeiro, Rio de Janeiro, 20940070, Brazil

Location

Related Publications (1)

  • Kimura OS, Freitas EH, Duarte ME, Cavalcanti AS, Fernandes MB. Tranexamic acid use in high-risk blood transfusion patients undergoing total hip replacement: a randomised controlled trial. Hip Int. 2021 Jul;31(4):456-464. doi: 10.1177/1120700019889947. Epub 2019 Dec 9.

    PMID: 31814452DERIVED

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
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 12, 2017

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2016

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)