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Completed

NCT Number: NCT03145493

Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid

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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Key information

Conditions

Arthroplasty, Replacement, Knee

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

drainage

Device

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

Primary outcomes

  1. Hb variation

    Time frame: 3 days after surgey

    Difference between Hb levels measured in pre-op and on postoperatively day 3.

Secondary outcomes

  1. Number of blood transfusions

    Time frame: from admission till 2 months after surgery

    Number of blood transfusions

  2. Cost of blood transfusions

    Time frame: from admission till 2 months after surgery

    Cost of blood transfusions

  3. Cost of suction drains

    Time frame: from admission till 2 months after surgery

    Cost of suction drains

  4. Range of motion of knee

    Time frame: preoperative visit , at the end of surgery, and on post-op day 3

    Range of motion of knee

  5. Length of hospital stay

    Time frame: from admission till 2 months after surgery

    Length of hospital stay

  6. additional surgery

    Time frame: from admission till 2 months after surgery

    possible causes for reoperation: hematoma drainage, infection, knee mobilization

  7. Clinical results

    Time frame: from admission till 2 months after surgery

    Major complications

  8. KOOS score

    Time frame: At preoperative visit and post-operative visit of six weeks after surgery

    Knee Injury and Osteoarthritis Outcome Score (KOOS); Scores are transformed to a 0-100 scale, 0: extreme knee problems, 100: no knee problems

  9. SF-12 score

    Time frame: At preoperative visit and post-operative visit of six weeks after surgery

    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)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 9, 2017
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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