Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid

Study Overview
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Brief Summary
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Problem Suction drains during TKA present certain costs to the health system and requires additional nursing care. There is no clear evidence that supports their use, and no studies so far have compared blood loss in patients with or without drains when TA is administered during TKA. Hypothesis During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used. Method Randomized controlled trial Monocentric, 3 surgeons Randomisation by sealed envelopes

Detailed Description
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During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.

Official Title
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(L'Effet Des Drains Aspiratifs en Arthroplastie du Genou Avec l'Utilisation de l'Acide Tranexamique)

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral primary total knee arthroplasty Exclusion Criteria: TKA revision Bilateral TKA Patients that refuse transfusions Contraindication to tranexamic acid use: allergy, thromboembolic history Coagulopathy Kidney failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usage of suction drains<br>Usage of suction drains | Device: drainage<br>* Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain<br>|
| No Intervention: No usage of suction drains<br>No usage of suction drains | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hb variation | Difference between Hb levels measured in pre-op and on postoperatively day 3. | 3 days after surgey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blood transfusions | Number of blood transfusions | from admission till 2 months after surgery | 
| Cost of blood transfusions | Cost of blood transfusions | from admission till 2 months after surgery | 
| Cost of suction drains | Cost of suction drains | from admission till 2 months after surgery | 
| Range of motion of knee | Range of motion of knee | preoperative visit , at the end of surgery, and on post-op day 3 | 
| Length of hospital stay | Length of hospital stay | from admission till 2 months after surgery | 
| additional surgery | possible causes for reoperation: hematoma drainage, infection, knee mobilization | from admission till 2 months after surgery | 
| Clinical results | Major complications | from admission till 2 months after surgery | 
| KOOS score | Knee Injury and Osteoarthritis Outcome Score (KOOS); Scores are transformed to a 0-100 scale, 0: extreme knee problems, 100: no knee problems | At preoperative visit and post-operative visit of six weeks after surgery | 
| SF-12 score | SF-12® Health Survey (SF-12); Physical and Mental Health Composite Scores (PCS & MCS) ; Minimum value: 0 (lowest level of health), Maximum value: 100 (highest level of health) | At preoperative visit and post-operative visit of six weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drainage, Suction, tranexamic acid