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NCT02327117 Clinical Trial

Low Dose Peri- Operative Intra Venous Teranexamic Acid Reduces Blood Loss After Total Knee Arthroplasty: A Double Blind Randomized Placebo Controlled Clinical Trial

Knee Arthroplasty, Total Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02327117
Other study ID # 392114
Secondary ID
Status Recruiting
Phase N/A
First received December 23, 2014
Last updated December 23, 2014
Start date January 2013

Study information
Verified date December 2014
Source Isfahan University of Medical Sciences
Contact Amin Nemati, MD
Phone 00989131009918
Email nemati@med.mui.ac.ir
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Individuals with osteoarthritis who indicated for primary TKA.

Exclusion Criteria:

- Previous history of ceberovascular diseases

- Previous history of myocardial infarction

- Candidates for bilateral TKA

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tranexamic Acid

• Normal saline

Locations
Country Name City State
Iran, Islamic Republic of Amin Nemati Isfahan

Sponsors (1)
Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hb level 48 hours after Total Knee Arthroplasty 48 hours after TKA
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