Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-03

Study Completion Date

2019-01-31

Brief Summary

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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

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Detailed Description

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

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Usage of suction drains

Group Type EXPERIMENTAL

drainage

Intervention Type DEVICE

Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain

No usage of suction drains

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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drainage

Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No