Clinical trial NCT03656445: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: total knee arthroplasty
tranexamic acid
without tourniquet
blood loss
function
multiple doses
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2018-09-04
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: hemoglobin change
timeFrame: 1st,2nd and 4th post-operative day
measure: Blood loss
timeFrame: 24 hours
measure: Blood loss
timeFrame: 48 hours
measure: Blood loss
timeFrame: 96 hours
measure: Platelet count change
timeFrame: 24 hours, 48 hours, 96 hours
measure: Need for trasfussion
timeFrame: 24 hours
measure: Need for trasfussion
timeFrame: 48 hours
measure: Need for trasfussion
timeFrame: 96 hours
Secondary outcomes:
measure: Knee Society Score (KSS) KSS
timeFrame: 2nd and 4th post op days + 6th week and 12th week
measure: Function Knee Society Score
timeFrame: 2nd and 4th post op days + 6th week and 12th week
measure: EuroQol
timeFrame: 2nd and 4th post op days + 6th week and 12th week
measure: VAS pain (analogue pain scale)
timeFrame: 2nd and 4th post op days + 6th week and 12th week
Other outcomes:
Locations:
Study officials:
References:
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.