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
1 other identifier
interventional
180
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedFirst Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
September 4, 2018
CompletedSeptember 5, 2018
August 1, 2018
1.5 years
August 30, 2018
August 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
hemoglobin change
Hemoglobin decrease/change during the four post-operative days
1st,2nd and 4th post-operative day
Blood loss
calculated total blood loss (TBL) the 1st post-op day
24 hours
Blood loss
calculated total blood loss (TBL) the 2nd post-op day
48 hours
Blood loss
calculated total blood loss (TBL) the 4th post-op day
96 hours
Platelet count change
Platelet count increase/decrease/change during the 1st,2nd and 4th day
24 hours, 48 hours, 96 hours
Need for trasfussion
Transfussion rate/quantity in 1st post-op day
24 hours
Need for trasfussion
Transfussion rate/quantity in 2nd post-op day
48 hours
Need for trasfussion
Transfussion rate/quantity in 3rd post-op day
96 hours
Secondary Outcomes (4)
Knee Society Score (KSS) KSS
2nd and 4th post op days + 6th week and 12th week
Function Knee Society Score
2nd and 4th post op days + 6th week and 12th week
EuroQol
2nd and 4th post op days + 6th week and 12th week
VAS pain (analogue pain scale)
2nd and 4th post op days + 6th week and 12th week
Study Arms (3)
Group A - Tranexamic Acid
ACTIVE COMPARATOR1 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
ACTIVE COMPARATOR1 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
ACTIVE COMPARATOR1 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
Interventions
1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia
Eligibility Criteria
You may qualify if:
- varus deformity less than 10o
- lack of extension not more than 10o
- flexion of at least 90o.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator Dr. Tzatzairis Themistoklis
Study Record Dates
First Submitted
August 30, 2018
First Posted
September 4, 2018
Study Start
October 1, 2015
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
September 5, 2018
Record last verified: 2018-08