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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02327117
Enrollment
90
Registered
2014-12-30
Start date
2013-01-31
Completion date
Unknown
Last updated
2016-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty, Total

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.

Interventions

DRUGTranexamic Acid
DRUGNormal saline

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Hb Level 48 Hours After Total Knee Arthroplasty48 hours after TKA

Countries

Iran

Participant flow

Participants by arm

ArmCount
Tranexamic Acid
Tranexamic Acid
45
Normal Saline
Normal saline
45
Total90

Baseline characteristics

CharacteristicTranexamic AcidNormal SalineTotal
Age, Continuous67.04 year
STANDARD_DEVIATION 8.01
65.66 year
STANDARD_DEVIATION 4.97
66.35 year
STANDARD_DEVIATION 6.49
Sex: Female, Male
Female
35 Participants32 Participants67 Participants
Sex: Female, Male
Male
10 Participants13 Participants23 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 450 / 45
serious
Total, serious adverse events
0 / 450 / 45

Outcome results

Primary

Hb Level 48 Hours After Total Knee Arthroplasty

Time frame: 48 hours after TKA

ArmMeasureValue (MEAN)Dispersion
Tranexamic AcidHb Level 48 Hours After Total Knee Arthroplasty10.92 gr/dLStandard Deviation 0.07
Normal SalineHb Level 48 Hours After Total Knee Arthroplasty10.23 gr/dLStandard Deviation 0.98

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026