Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid

Not Applicable

Completed

• Conditions: Arthroplasty, Replacement, Knee

• Registration Number: NCT03145493
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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 Timeline

• Study Start: 2014-10-03
• Study First Submitted: 2017-03-03
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-09
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-02
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hb variation	3 days after surgey	Difference between Hb levels measured in pre-op and on postoperatively day 3.

Secondary Outcome Measures

Name	Time	Method
Number of blood transfusions	from admission till 2 months after surgery	Number of blood transfusions
Range of motion of knee	preoperative visit , at the end of surgery, and on post-op day 3	Range of motion of knee
additional surgery	from admission till 2 months after surgery	possible causes for reoperation: hematoma drainage, infection, knee mobilization
Clinical results	from admission till 2 months after surgery	Major complications
Cost of suction drains	from admission till 2 months after surgery	Cost of suction drains
Length of hospital stay	from admission till 2 months after surgery	Length of hospital stay
KOOS score	At preoperative visit and post-operative visit of six weeks after surgery	Knee Injury and Osteoarthritis Outcome Score (KOOS); Scores are transformed to a 0-100 scale, 0: extreme knee problems, 100: no knee problems
Cost of blood transfusions	from admission till 2 months after surgery	Cost of blood transfusions
SF-12 score	At preoperative visit and post-operative visit of six weeks after surgery	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)

Trial Locations

Locations (1)

Centre Hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montreal, Quebec, Canada