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)
1 other identifier
interventional
140
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2014
CompletedFirst Submitted
Initial submission to the registry
March 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedJuly 17, 2020
February 1, 2019
4.3 years
March 3, 2017
July 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hb variation
Difference between Hb levels measured in pre-op and on postoperatively day 3.
3 days after surgey
Secondary Outcomes (9)
Number of blood transfusions
from admission till 2 months after surgery
Cost of blood transfusions
from admission till 2 months after surgery
Cost of suction drains
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
Length of hospital stay
from admission till 2 months after surgery
- +4 more secondary outcomes
Study Arms (2)
Usage of suction drains
EXPERIMENTALUsage of suction drains
No usage of suction drains
NO INTERVENTIONNo usage of suction drains
Interventions
Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain
Eligibility Criteria
You may qualify if:
- Unilateral primary total knee arthroplasty
You may not qualify if:
- TKA revision
- Bilateral TKA
- Patients that refuse transfusions
- Contraindication to tranexamic acid use: allergy, thromboembolic history
- Coagulopathy
- Kidney failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric Lavoie, MD MSc FRCSC
CHUM
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2017
First Posted
May 9, 2017
Study Start
October 3, 2014
Primary Completion
January 31, 2019
Study Completion
January 31, 2019
Last Updated
July 17, 2020
Record last verified: 2019-02