Effect of Suction Drains in Total Knee Arthroplasty With... | NCT03145493

Studies
Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid

NCT03145493

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Status

Completed

Last Update Posted

Jul 17, 2020Actual

Enrollment

140Actual

Phase

Not Applicable

Conditions

Arthroplasty, Replacement, Knee

Interventions

drainage

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 3, 2014Actual

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Mar 3, 2017

First Submission Date that Met QC Criteria

May 4, 2017

First Posted Date

May 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2020

Last Update Posted Date

Jul 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Usage of suction drains	Experimental	Usage of suction drains	Device: drainage
No usage of suction drains	No Intervention	No usage of suction drains

Interventions

Name	Type	Description	Arm Group Labels	Other Names
drainage	Device	Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain	Usage of suction drains

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frédéric Lavoie, MD MSc FRCSC	CHUM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de l'Université de Montréal (CHUM)		Montreal	Quebec	H2L 4M1	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D004322	Drainage

Ancestor Terms

ID	Term
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

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