Clinical trial NCT03915756: Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid
Official title: Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Knee replacement
Blood loss
Wound drainage
Lead sponsor: Hospital Beatriz Ângelo
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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 \>15⁰ of varus or valgus

Primary outcomes:
measure: Total RBC loss
timeFrame: 96 hours
measure: Total RBC loss
timeFrame: 24 hours
measure: Total RBC loss
timeFrame: 1 hour
measure: Blood transfusion requirements
timeFrame: 96 hours
measure: Knee Society Score score
timeFrame: 14 days
Secondary outcomes:
measure: Haematocrit level
timeFrame: 1 hour
measure: Haematocrit level
timeFrame: 24 hours
measure: Haematocrit level
timeFrame: 96 hours
measure: Haemoglobin level
timeFrame: 1 hour
measure: Haemoglobin level
timeFrame: 24 hours
measure: Haemoglobin level
timeFrame: 96 hours
measure: Surgery duration
timeFrame: 0hour
measure: Length of skin incision
timeFrame: 0 hour
measure: Tourniquet duration
timeFrame: 0 hour
measure: Surgical blood loss
timeFrame: 0 hour
measure: Iron
timeFrame: 96 hours
measure: Transfusion reactions
timeFrame: 96 hours
measure: Drain volume
timeFrame: 24 hours
measure: MKC
timeFrame: 48 hours
measure: MKC
timeFrame: 96 hours
measure: MKC
timeFrame: 14 days
measure: ROM
timeFrame: 48 hours
measure: ROM
timeFrame: 96 hours
measure: ROM
timeFrame: 14 days
measure: Fluidotherapy excess
timeFrame: 96 hours
measure: Wound complications (i. e., wound dehiscence, infection)
timeFrame: 14 days
measure: Lower leg deep vein thrombosis
timeFrame: 14 days
Other outcomes:
Locations:
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
Study officials:
affiliation: Hospital Beatriz Angelo
name: Afonso Cardoso
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.12659/msm.895571.
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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.
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.
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.
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.
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.
citation: Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.