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Tranexamic Acid in Total Knee Replacement

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic Acid
Tranexamic Acid
Tranexamic Acid
Sponsored by
Democritus University of Thrace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring total knee arthroplasty, tranexamic acid, without tourniquet, blood loss, function, multiple doses

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group A - Tranexamic Acid

    Group B - Tranexamic Acid

    Group C - Tranexamic Acid

    Arm Description

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

    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

    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

    Outcomes

    Primary Outcome Measures

    hemoglobin change
    Hemoglobin decrease/change during the four post-operative days
    Blood loss
    calculated total blood loss (TBL) the 1st post-op day
    Blood loss
    calculated total blood loss (TBL) the 2nd post-op day
    Blood loss
    calculated total blood loss (TBL) the 4th post-op day
    Platelet count change
    Platelet count increase/decrease/change during the 1st,2nd and 4th day
    Need for trasfussion
    Transfussion rate/quantity in 1st post-op day
    Need for trasfussion
    Transfussion rate/quantity in 2nd post-op day
    Need for trasfussion
    Transfussion rate/quantity in 3rd post-op day

    Secondary Outcome Measures

    Knee Society Score (KSS) KSS
    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)
    Function Knee Society Score
    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)
    EuroQol
    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)
    VAS pain (analogue pain scale)
    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])

    Full Information

    First Posted
    August 30, 2018
    Last Updated
    August 31, 2018
    Sponsor
    Democritus University of Thrace
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03656445
    Brief Title
    Tranexamic Acid in Total Knee Replacement
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2015 (Actual)
    Primary Completion Date
    March 31, 2017 (Actual)
    Study Completion Date
    March 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Democritus University of Thrace

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteo Arthritis Knee
    Keywords
    total knee arthroplasty, tranexamic acid, without tourniquet, blood loss, function, multiple doses

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A - Tranexamic Acid
    Arm Type
    Active Comparator
    Arm Description
    1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia
    Arm Title
    Group B - Tranexamic Acid
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Group C - Tranexamic Acid
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid
    Other Intervention Name(s)
    Transamin, Cyklokapron
    Intervention Description
    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
    Intervention Name(s)
    Tranexamic Acid
    Other Intervention Name(s)
    Transamin, Cyklokapron
    Intervention Description
    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
    Intervention Name(s)
    Tranexamic Acid
    Other Intervention Name(s)
    Transamin, Cyklokapron
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    hemoglobin change
    Description
    Hemoglobin decrease/change during the four post-operative days
    Time Frame
    1st,2nd and 4th post-operative day
    Title
    Blood loss
    Description
    calculated total blood loss (TBL) the 1st post-op day
    Time Frame
    24 hours
    Title
    Blood loss
    Description
    calculated total blood loss (TBL) the 2nd post-op day
    Time Frame
    48 hours
    Title
    Blood loss
    Description
    calculated total blood loss (TBL) the 4th post-op day
    Time Frame
    96 hours
    Title
    Platelet count change
    Description
    Platelet count increase/decrease/change during the 1st,2nd and 4th day
    Time Frame
    24 hours, 48 hours, 96 hours
    Title
    Need for trasfussion
    Description
    Transfussion rate/quantity in 1st post-op day
    Time Frame
    24 hours
    Title
    Need for trasfussion
    Description
    Transfussion rate/quantity in 2nd post-op day
    Time Frame
    48 hours
    Title
    Need for trasfussion
    Description
    Transfussion rate/quantity in 3rd post-op day
    Time Frame
    96 hours
    Secondary Outcome Measure Information:
    Title
    Knee Society Score (KSS) KSS
    Description
    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)
    Time Frame
    2nd and 4th post op days + 6th week and 12th week
    Title
    Function Knee Society Score
    Description
    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)
    Time Frame
    2nd and 4th post op days + 6th week and 12th week
    Title
    EuroQol
    Description
    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)
    Time Frame
    2nd and 4th post op days + 6th week and 12th week
    Title
    VAS pain (analogue pain scale)
    Description
    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])
    Time Frame
    2nd and 4th post op days + 6th week and 12th week

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clinics in geriatric medicine. Aug 2010;26(3):355-369. 2. Litwic A, Edwards MH, Dennison EM, Cooper C. Epidemiology and burden of osteoarthritis. British medical bulletin. 2013;105:185-199. 3. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. The Journal of bone and joint surgery. American volume. Apr 2007;89(4):780-785. 4. Bourne RB, McCalden RW, MacDonald SJ, Mokete L, Guerin J. Influence of patient factors on TKA outcomes at 5 to 11 years followup. Clinical orthopaedics and related research. Nov 2007;464:27-31. 5. Anderson JG, Wixson RL, Tsai D, Stulberg SD, Chang RW. Functional outcome and patient satisfaction in total knee patients over the age of 75. The Journal of arthroplasty. Oct 1996;11(7):831-840. 6. Mulhall KJ, Ghomrawi HM, Bershadsky B, Saleh KJ. Functional improvement after total knee arthroplasty revision: new observations on the dimensional nature of outcome. Journal of orthopaedic surgery and research. Dec 07 2007;2:25. 7. Saleh KJ, Dykes DC, Tweedie RL, et al. Functional outcome after total knee arthroplasty revision: a meta-analysis. The Journal of arthroplasty. Dec 2002;17(8):967-977. 8. Sikorski JM. Alignment in total knee replacement. The Journal of bone and joint surgery. British volume. Sep 2008;90(9):1121-1127. 9. Blumberg N. Allogeneic transfusion and infection: economic and clinical implications. Semin Hematol. 1997/07// 1997;34(3 Suppl 2):34-40. 10. Vamvakas EC, Blajchman MA. Transfusion-related mortality: the ongoing risks of allogeneic blood transfusion and the available strategies for their prevention. Blood. Apr 09 2009;113(15):3406-3417. 11. Berry DJ, Bozic KJ. Current practice patterns in primary hip and knee arthroplasty among members of the American Association of Hip and Knee Surgeons. The Journal of arthroplasty. Sep 2010;25(6 Suppl):2-4. 12. Themistoklis T, Theodosia V, Konstantinos K, Georgios DI. Perioperative blood management strategies for patients undergoing total knee replacement: Where do we stand now? World journal of orthopedics. Jun 18 2017;8(6):441-454. 13. Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. Journal of orthopaedic surgery and research. 2014;9:13-13. 14. Zhang Q, Dong J, Gong K, Li X, Zheng S, Wen T. [Effects of Tourniquet Use on Perioperative Outcome in Total Knee Arthroplasty]. Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. Apr 2016;30(4):421-425. 15. Du Z, Liu P, Zhang Y, Li D, Li M. [Effect of tourniquet on perioperative blood loss and short-term effectiveness in total knee arthroplasty]. Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. Nov 2013;27(11):1318-1323. 16. Li X, Yin L, Chen ZY, et al. The effect of tourniquet use in total knee arthroplasty: grading the evidence through an updated meta-analysis of randomized, controlled trials. European journal of orthopaedic surgery & traumatology : orthopedie traumatologie. Aug 2014;24(6):973-986. 17. Tetro AM, Rudan JF. The effects of a pneumatic tourniquet on blood loss in total knee arthroplasty. Canadian journal of surgery. Journal canadien de chirurgie. Feb 2001;44(1):33-38.
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    Tranexamic Acid in Total Knee Replacement

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