Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03145493
• Other study ID #: CE 14.150
• Status: Completed
• Phase: N/A
• Start date: October 3, 2014
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

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

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Université de Montréal (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hb variation	Difference between Hb levels measured in pre-op and on postoperatively day 3.	3 days after surgey
Secondary	Number of blood transfusions	Number of blood transfusions	from admission till 2 months after surgery
Secondary	Cost of blood transfusions	Cost of blood transfusions	from admission till 2 months after surgery
Secondary	Cost of suction drains	Cost of suction drains	from admission till 2 months after surgery
Secondary	Range of motion of knee	Range of motion of knee	preoperative visit , at the end of surgery, and on post-op day 3
Secondary	Length of hospital stay	Length of hospital stay	from admission till 2 months after surgery
Secondary	additional surgery	possible causes for reoperation: hematoma drainage, infection, knee mobilization	from admission till 2 months after surgery
Secondary	Clinical results	Major complications	from admission till 2 months after surgery
Secondary	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	At preoperative visit and post-operative visit of six weeks after surgery
Secondary	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)	At preoperative visit and post-operative visit of six weeks after surgery