Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid

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

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

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: drainage

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • Centre Hospitalier de l'Universite de Montreal (CHUM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Investigators: Principal Investigator: Frédéric Lavoie, MD MSc FRCSC, CHUM

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2014
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 15, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: tranexamic acid; Drainage, Suction
• Other Study ID Numbers: CE 14.150

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No