Arthroplasty, Replacement, KneeNCT03145493
Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid
A study testing drainage in people with Arthroplasty, Replacement, Knee, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- drainage
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 3 Oct 2014to 31 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral primary total knee arthroplasty
Who cannot join
- TKA revision
- Bilateral TKA
- Patients that refuse transfusions
- Contraindication to tranexamic acid use: allergy, thromboembolic history
- Coagulopathy
- Kidney failure
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
Official title: (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
Read the detailed description
During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- drainage
- Keywords
- Drainage, Suction, tranexamic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drainageDevice
Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain
| Study group | Role | What they receive |
|---|---|---|
| Usage of suction drains | Experimental | Usage of suction drains Receives: Device: drainage |
| No usage of suction drains | No intervention | No usage of suction drains |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb variation
Difference between Hb levels measured in pre-op and on postoperatively day 3.
Measured: 3 days after surgey
Secondary outcomes (9)
Number of blood transfusions
Number of blood transfusions
Measured: from admission till 2 months after surgery
Cost of blood transfusions
Cost of blood transfusions
Measured: from admission till 2 months after surgery
Cost of suction drains
Cost of suction drains
Measured: from admission till 2 months after surgery
Range of motion of knee
Range of motion of knee
Measured: preoperative visit , at the end of surgery, and on post-op day 3
Length of hospital stay
Length of hospital stay
Measured: from admission till 2 months after surgery
additional surgery
possible causes for reoperation: hematoma drainage, infection, knee mobilization
Measured: from admission till 2 months after surgery
Clinical results
Major complications
Measured: 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
Measured: 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)
Measured: At preoperative visit and post-operative visit of six weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start3 Oct 2014
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric Lavoie, MD MSc FRCSC, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145493
- Sponsor's protocol ID
- CE 14.150
- Status last verified
- Feb 2019
- First submitted
- 3 Mar 2017
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (L'Effet Des Drains Aspiratifs en Arthroplastie du Genou Avec l'Utilisation de l'Acide Tranexamique)
- ClinicalTrials.gov ID
- NCT03145493
- Acronym / sponsor ID
- CE 14.150
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Drainage, Suction, tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 3 Oct 2014 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usage of suction drains | Experimental | Device: drainageUsage of suction drains |
| No usage of suction drains | No intervention | –No usage of suction drains |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral primary total knee arthroplasty
Key exclusion criteria (6 listed)
- TKA revision
- Bilateral TKA
- Patients that refuse transfusions
- Contraindication to tranexamic acid use: allergy, thromboembolic history
- Coagulopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drainageAdministration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain | Device | Usage of suction drains |
Primary outcome
Hb variation
Time frame: 3 days after surgey
Difference between Hb levels measured in pre-op and on postoperatively day 3.
9 secondary outcomes
Number of blood transfusions
Time frame: from admission till 2 months after surgery
Cost of blood transfusions
Time frame: from admission till 2 months after surgery
Cost of suction drains
Time frame: from admission till 2 months after surgery
Range of motion of knee
Time frame: preoperative visit , at the end of surgery, and on post-op day 3
Length of hospital stay
Time frame: from admission till 2 months after surgery
additional surgery
Time frame: from admission till 2 months after surgery
Clinical results
Time frame: from admission till 2 months after surgery
KOOS score
Time frame: At preoperative visit and post-operative visit of six weeks after surgery
SF-12 score
Time frame: At preoperative visit and post-operative visit of six weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric Lavoie, MD MSc FRCSC principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drainage in people with Arthroplasty, Replacement, Knee, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hb variation (time frame: 3 days after surgey). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.