NCT02327117

Brief Summary

Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The null hypothesis of this study was that TA has no effect on post surgical bleeding in patients undergoes TKA.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

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, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 22, 2016

Completed
Last Updated

July 22, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

December 23, 2014

Results QC Date

June 12, 2016

Last Update Submit

June 12, 2016

Conditions

Knee Arthroplasty, Total

Outcome Measures

Primary Outcomes (1)

  • Hb Level 48 Hours After Total Knee Arthroplasty

    48 hours after TKA

Study Arms (2)

Tranexamic acid

EXPERIMENTAL
Drug: Tranexamic Acid

Normal Saline

PLACEBO COMPARATOR
Drug: Normal saline

Interventions

Tranexamic AcidDRUG
Tranexamic acid
Normal salineDRUG
Normal Saline

Eligibility Criteria

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

You may qualify if:

  • Individuals with osteoarthritis who indicated for primary TKA.

You may not qualify if:

  • Previous history of ceberovascular diseases
  • Previous history of myocardial infarction
  • Candidates for bilateral TKA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amin Nemati

Isfahan, Isfahan, 8158119749, Iran

Location

MeSH Terms

Interventions

Tranexamic AcidSaline Solution

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Amin Nemati
Organization
Isfahan University of Medical Sciences
nemati@med.mui.ac.ir
00989131009918

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic surgery resident,Orthopedic department,Alzahra hospital,Isfahan University of Medical Sciences,Isfahan,Iran

Study Record Dates

First Submitted

December 23, 2014

First Posted

December 30, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Last Updated

July 22, 2016

Results First Posted

July 22, 2016

Record last verified: 2016-06

Locations

IR(1)