Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid
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|ClinicalTrials.gov Identifier: NCT03915756|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Procedure: Drainage of surgical wound||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Postoperative Drainage in Total Knee Arthroplasty in the Presence of Tranexamic Acid: a Clinical Trial|
|Actual Study Start Date :||August 22, 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: With drain
Participants who received a drain during surgery
Procedure: Drainage of surgical wound
Introduction of a drain before full fascial closure
No Intervention: Without drain
Participants who did not receive a drain during surgery
- Total RBC loss [ Time Frame: 96 hours ]Total red blood cells loss after surgery
- Total RBC loss [ Time Frame: 24 hours ]Total red blood cells loss after surgery
- Total RBC loss [ Time Frame: 1 hour ]Total red blood cells loss after surgery
- Blood transfusion requirements [ Time Frame: 96 hours ]Blood transfusions requirements
- Knee Society Score score [ Time Frame: 14 days ]Knee Society Score measuring function of Knee (0-100 total score, higher values, better outcome)
- Haematocrit level [ Time Frame: 1 hour ]Haematocrit level
- Haematocrit level [ Time Frame: 24 hours ]Haematocrit level
- Haematocrit level [ Time Frame: 96 hours ]Haematocrit level
- Haemoglobin level [ Time Frame: 1 hour ]Haemoglobin level
- Haemoglobin level [ Time Frame: 24 hours ]Haemoglobin level
- Haemoglobin level [ Time Frame: 96 hours ]Haemoglobin level
- Surgery duration [ Time Frame: 0hour ]Surgery duration (min)
- Length of skin incision [ Time Frame: 0 hour ]Length of skin incision
- Tourniquet duration [ Time Frame: 0 hour ]Tourniquet duration (min)
- Surgical blood loss [ Time Frame: 0 hour ]Surgical blood loss (mL)
- Iron [ Time Frame: 96 hours ]Iron products used
- Transfusion reactions [ Time Frame: 96 hours ]Transfusion reactions
- Drain volume [ Time Frame: 24 hours ]Drain volume (mL)
- MKC [ Time Frame: 48 hours ]Midpatellar Knee Circumference (cm)
- MKC [ Time Frame: 96 hours ]Midpatellar Knee Circumference (cm)
- MKC [ Time Frame: 14 days ]Midpatellar Knee Circumference (cm)
- ROM [ Time Frame: 48 hours ]Range of motion (°)
- ROM [ Time Frame: 96 hours ]Range of motion (°)
- ROM [ Time Frame: 14 days ]Range of motion (°)
- Fluidotherapy excess [ Time Frame: 96 hours ]Fluidotherapy excess (mL)
- Wound complications (i. e., wound dehiscence, infection) [ Time Frame: 14 days ]Wound complications (i. e., wound dehiscence, infection)
- Lower leg deep vein thrombosis [ Time Frame: 14 days ]Lower leg deep vein thrombosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915756
|Contact: Afonso Cardosoemail@example.com|
|Hospital Beatriz Angelo||Recruiting|
|Loures, Portugal, 2674-514|
|Contact: Afonso Cardoso 00351918972882 firstname.lastname@example.org|
|Principal Investigator:||Afonso Cardoso||Hospital Beatriz Angelo|