Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid

Osteoarthritis, Knee Clinical Trial

Official title:

Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid: a Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03915756
• Other study ID #: 0389
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2019
• Est. completion date: July 2022

Study information

• Verified date: February 2021
• Source: Hospital Beatriz Ângelo
• Contact: Afonso Cardoso
• Phone: 00351918972882
• Email: afonso.cardoso[@]hbeatrizangelo.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator's aim with this study is to address, with the new paradigm of tranexamic acid, the role of wound drainage following total knee arthroplasty in blood loss, blood transfusion requirements and functional recovery

Description:

All participants will attend a preoperatory appointment with an anaesthesiologist where preoperative haemoglobin will be optimized (Hg > 13 g/L).

Randomization will be done by opening a closed envelop with the selected group from a bag at the time of wound closure.

Collected preoperative information will include age, gender, weight, height, body-mass index, underlying diseases, operated side, haematocrit, haemoglobin level, midpatellar knee circumference and range of movement. Blood work was performed within 1 hour of the beginning of the surgery. Clinical parameters will be collected before anaesthesia.

In all cases, the surgeon will perform a medial parapatellar approach with a standard incision with the participants in the supine position. The SIGMA PFC total knee system (DePuy, Warsaw, In) and its posterior-stabilized design with a rotatory platform will be used. All participants will be under a subarachnoid spinal block.

A tourniquet will be used (pressure of 350 mmHg) from the beginning of the surgery and deflated for haemostasis before wound closure. At this time, before complete water-tight fascial closure, the patients will be allocated to group With or Without drain as described, and a drain will be placed in a subfascial position. The drain will be left clamped for 1 hour and will be left in place for 24 hours. Compressive dressings will be applied at the end of the surgery. Continuous passive motion will be started within 24 hours of surgery (0-60°, progressing as tolerated).

In all participants, about 30min before tourniquet release, intravenous tranexamic acid will be used with an initial bolus of 10 mg/kg administered in 10min followed by a perfusion of 10mg/kg over 4h. For postoperative analgesia, a femoral triangle and a popliteal block (anterior approach) will be done in all participants.

A standard fluid therapy of a balanced crystalloid solution (perfusion 10ml/kg/h) will be administered to all patients. After tourniquet release, during haemostasis and in the recovery room, an eventual need of increasing fluid therapy perfusion or a bolus will be noted in the patient's file.

Hidden blood loss will be calculated according to the haemoglobin balance method as it suggested to be the most reliable method. Total blood volume will be calculated as described by Nadler et al.

The normality of the data will be tested with the Shapiro-Wilk test/Kolmogorov-Smirnov test. The data will be compared and analyzed using Student's t-test for independent samples, or the Mann-Whitney test, according to the normality of the data. The correlation of data will be analyzed with the Pearson or Spearman correlation coefficient according to its normality. Nominal variables will be compared using the chi-square test. P-values less than 0.05 will be considered significant. Dedicated statistical software (SPSS version 21, SPSS Inc., Chicago, USA) will be used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: July 2022
• Est. primary completion date: May 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Consecutive patients admitted to perform a primary unilateral total knee arthroplasty

Exclusion Criteria:

• Contraindication to take tranexamic acid

• hematologic disease with a higher risk of bleeding

• abnormal coagulation tests

• refusal of blood transfusions

• inadequate preoperatory optimization

• deformity >15° of varus or valgus

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• Drainage of surgical wound
Introduction of a drain before full fascial closure

Locations

Country	Name	City	State
Portugal	Hospital Beatriz Angelo	Loures

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Beatriz Ângelo

Country where clinical trial is conducted

Portugal, 

References & Publications (11)

Banerjee S, Kapadia BH, Issa K, McElroy MJ, Khanuja HS, Harwin SF, Mont MA. Postoperative blood loss prevention in total knee arthroplasty. J Knee Surg. 2013 Dec;26(6):395-400. doi: 10.1055/s-0033-1357491. Epub 2013 Oct 11. Review. — View Citation

Craik JD, Ei Shafie SA, Kidd AG, Twyman RS. Can local administration of tranexamic acid during total knee arthroplasty reduce blood loss and transfusion requirements in the absence of surgical drains? Eur J Orthop Surg Traumatol. 2014 Apr;24(3):379-84. doi: 10.1007/s00590-013-1206-1. Epub 2013 Mar 14. — View Citation

Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19. — View Citation

Gao FQ, Li ZJ, Zhang K, Sun W, Zhang H. Four Methods for Calculating Blood-loss after Total Knee Arthroplasty. Chin Med J (Engl). 2015 Nov 5;128(21):2856-60. doi: 10.4103/0366-6999.168041. — View Citation

Huang GP, Jia XF, Xiang Z, Ji Y, Wu GY, Tang Y, Li J, Zhang J. Tranexamic Acid Reduces Hidden Blood Loss in Patients Undergoing Total Knee Arthroplasty: A Comparative Study and Meta-Analysis. Med Sci Monit. 2016 Mar 10;22:797-802. — View Citation

Liao L, Chen Y, Tang Q, Chen YY, Wang WC. Tranexamic acid plus drain-clamping can reduce blood loss in total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:334-341. doi: 10.1016/j.ijsu.2018.01.040. Epub 2018 Feb 3. Review. — View Citation

Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. — View Citation

NIH Consensus Panel. NIH Consensus Statement on total knee replacement December 8-10, 2003. J Bone Joint Surg Am. 2004 Jun;86(6):1328-35. Review. — View Citation

Wang H, Shen B, Zeng Y. Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials. Knee. 2014 Dec;21(6):987-93. doi: 10.1016/j.knee.2014.09.010. Epub 2014 Oct 23. Review. — View Citation

Yang Y, Lv YM, Ding PJ, Li J, Ying-Ze Z. The reduction in blood loss with intra-articular injection of tranexamic acid in unilateral total knee arthroplasty without operative drains: a randomized controlled trial. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):135-9. doi: 10.1007/s00590-014-1461-9. Epub 2014 May 10. — View Citation

Zhang Y, Zhang JW, Wang BH. Efficacy of tranexamic acid plus drain-clamping to reduce blood loss in total knee arthroplasty: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(26):e7363. doi: 10.1097/MD.0000000000007363. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total RBC loss	Total red blood cells loss after surgery	96 hours
Primary	Total RBC loss	Total red blood cells loss after surgery	24 hours
Primary	Total RBC loss	Total red blood cells loss after surgery	1 hour
Primary	Blood transfusion requirements	Blood transfusions requirements	96 hours
Primary	Knee Society Score score	Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)	14 days
Secondary	Haematocrit level	Haematocrit level	1 hour
Secondary	Haematocrit level	Haematocrit level	24 hours
Secondary	Haematocrit level	Haematocrit level	96 hours
Secondary	Haemoglobin level	Haemoglobin level	1 hour
Secondary	Haemoglobin level	Haemoglobin level	24 hours
Secondary	Haemoglobin level	Haemoglobin level	96 hours
Secondary	Surgery duration	Surgery duration (min)	0hour
Secondary	Length of skin incision	Length of skin incision	0 hour
Secondary	Tourniquet duration	Tourniquet duration (min)	0 hour
Secondary	Surgical blood loss	Surgical blood loss (mL)	0 hour
Secondary	Iron	Iron products used	96 hours
Secondary	Transfusion reactions	Transfusion reactions	96 hours
Secondary	Drain volume	Drain volume (mL)	24 hours
Secondary	MKC	Midpatellar Knee Circumference (cm)	48 hours
Secondary	MKC	Midpatellar Knee Circumference (cm)	96 hours
Secondary	MKC	Midpatellar Knee Circumference (cm)	14 days
Secondary	ROM	Range of motion (°)	48 hours
Secondary	ROM	Range of motion (°)	96 hours
Secondary	ROM	Range of motion (°)	14 days
Secondary	Fluidotherapy excess	Fluidotherapy excess (mL)	96 hours
Secondary	Wound complications (i. e., wound dehiscence, infection)	Wound complications (i. e., wound dehiscence, infection)	14 days
Secondary	Lower leg deep vein thrombosis	Lower leg deep vein thrombosis	14 days