Tranexamic Acid in Total Knee Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-01

Study Completion Date

2017-03-31

Brief Summary

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Multiple intravenous Tranexamic Acid doses can reduce postoperative blood loss and improve the functional outcome in total knee arthroplasty without tourniquet: a randomized controlled study.

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Detailed Description

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A total of 180 patients undergoing TKA for knee osteoarthritis were stratified in three equal groups. All surgeries were performed under spinal anesthesia, without tourniquet and patients should be in agreement with the established inclusion/exclusion criteria. Group A (60 patients) received 1g of IV TXA, Group B (60 patients) received an additional dose of IV TXA and Group C (60 patients) received three doses of IV TXA. The measured outcomes were the Hemoglobin (Hb) decrease, the transfusion rate, the functional, quality of life (QoL) and pain assessment based on their corresponding scoring system.

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A - Tranexamic Acid

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia

Group B - Tranexamic Acid

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision

Group C - Tranexamic Acid

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectively

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectivel

Interventions

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Tranexamic Acid

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia

Intervention Type DRUG

Tranexamic Acid

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision

Intervention Type DRUG

Tranexamic Acid

1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectivel

Intervention Type DRUG

Other Intervention Names

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Transamin Cyklokapron Transamin Cyklokapron Transamin Cyklokapron

Eligibility Criteria

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Inclusion Criteria

1. varus deformity less than 10o
2. lack of extension not more than 10o
3. flexion of at least 90o.

Exclusion Criteria

1. uncontrolled medical diseases/comorbidities
2. allergy and/or hypersensitivity to TXA
3. a known history of thromboembolic disease, cardiovascular disease
4. coronary or vascular stent placed within the past 12 months
5. cerebral vascular disease (a history of stroke)
6. subarachnoid hemorrhage
7. preoperative coagulopathy (a platelet \[PLT\] count \<150,000/mm3 or an international normalized ratio greater than 1.5
8. preoperative renal or hepatic dysfunction
9. retinal vein or artery occlusion
10. patients with anemia (\<12 g/dL for female, \<13 g/dL for male)

Eligible Sex

ALL

Accepts Healthy Volunteers

No