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Completed

NCT Number: NCT03656445

Tranexamic Acid in Total Knee Replacement

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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Key information

Conditions

Osteo Arthritis Knee Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Tranexamic Acid

Drug

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

Other names: Transamin, Cyklokapron

Primary outcomes

  1. hemoglobin change

    Time frame: 1st,2nd and 4th post-operative day

    Hemoglobin decrease/change during the four post-operative days

  2. Blood loss

    Time frame: 24 hours

    calculated total blood loss (TBL) the 1st post-op day

  3. Blood loss

    Time frame: 48 hours

    calculated total blood loss (TBL) the 2nd post-op day

  4. Blood loss

    Time frame: 96 hours

    calculated total blood loss (TBL) the 4th post-op day

  5. Platelet count change

    Time frame: 24 hours, 48 hours, 96 hours

    Platelet count increase/decrease/change during the 1st,2nd and 4th day

  6. Need for trasfussion

    Time frame: 24 hours

    Transfussion rate/quantity in 1st post-op day

  7. Need for trasfussion

    Time frame: 48 hours

    Transfussion rate/quantity in 2nd post-op day

  8. Need for trasfussion

    Time frame: 96 hours

    Transfussion rate/quantity in 3rd post-op day

Secondary outcomes

  1. Knee Society Score (KSS) KSS

    Time frame: 2nd and 4th post op days + 6th week and 12th week

    Change in this Score which is an objective scoring system to rate the knee and patient's functional abilities such as walking and stair climbing before and after TKA. Maximum score is 100 (best functionality) and lowest score is 0 (worst functionality)

  2. Function Knee Society Score

    Time frame: 2nd and 4th post op days + 6th week and 12th week

    Change in this score which utilizes walking distance and stair climbing as the main parameters, with deduction for the use of a walking aid. Maximum score is 100 (best functionality) and lowest score is 0 (worst functionality)

  3. EuroQol

    Time frame: 2nd and 4th post op days + 6th week and 12th week

    Changes in this score which is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Crosswalk value sets for the EQ-5D-5L has been used to asses the results into numbers. Maximum score is 1 (which means best quality of life) and the lowest is -0.594(which means the worst quality of life)

  4. VAS pain (analogue pain scale)

    Time frame: 2nd and 4th post op days + 6th week and 12th week

    The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10 [100-mm scale])

Sponsors and collaborators

Lead sponsor

Democritus University of Thrace

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 4, 2018
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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