(L'Effet Des Drains Aspiratifs en Arthroplastie du Genou Avec l'Utilisation de l'Acide Tranexamique)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Hb variation
Study Overview
Brief Summary
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
During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usage of suction drains
Usage of suction drains
Intervention: drainage (Device)
No usage of suction drains
No usage of suction drains
Outcomes
Primary Outcomes
Hb variation
Time Frame: 3 days after surgey
Difference between Hb levels measured in pre-op and on postoperatively day 3.
Secondary Outcomes
- Number of blood transfusions(from admission till 2 months after surgery)
- Range of motion of knee(preoperative visit , at the end of surgery, and on post-op day 3)
- additional surgery(from admission till 2 months after surgery)
- Clinical results(from admission till 2 months after surgery)
- Cost of suction drains(from admission till 2 months after surgery)
- Length of hospital stay(from admission till 2 months after surgery)
- KOOS score(At preoperative visit and post-operative visit of six weeks after surgery)
- Cost of blood transfusions(from admission till 2 months after surgery)
- SF-12 score(At preoperative visit and post-operative visit of six weeks after surgery)