Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT

NCT01449552 | Completed

• 1 other identifier: Si463/2007
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total knee arthroplasty (TKA) may be associated with significant blood loss, and transfusion carries substantial risk of immunologic reaction and disease transmission. Several methods reportedly reduce postoperative blood loss and avoid homologous blood transfusion with traditional TKA approaches. Drain clamping was one of the widely used method and tranexamic acid administration was the recently adjuvant method to reduce blood loss in TKA. However, there were several regimens in either drain clamping or tranexamic acid administration reported in previous studies. Our objective was to compare the efficacy of our drain clamping protocol and/or tranexamic acid regimen for reducing blood loss and transfusion in TKA.

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Postoperative blood loss

  48 hours after operation

Secondary Outcomes (1)

• Number of blood transfusion

  5 days

Study Arms (4)

Group A

EXPERIMENTAL

No clamp and placebo

Other: No clamp and placebo

Group B

EXPERIMENTAL

Tranexamic acid

Drug: Tranexamic acid

Group C

EXPERIMENTAL

Drain clamping

Procedure: Drain clamping

Group D

EXPERIMENTAL

Drain clamping and tranexamic acid

Other: Drain clamping and tranexamic acid

Interventions

Tranexamic acid DRUG

the drain was not clamped and the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.

Group B

Drain clamping PROCEDURE

the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).

Group C

Drain clamping and tranexamic acid OTHER

the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.

Group D

No clamp and placebo OTHER

The drain was not clamped. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).

Group A

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients younger than 85 years with knee osteoarthritis

You may not qualify if:

• The patient diagnosed secondary osteoarthritis (eg, rheumatoid arthritis, posttraumatic arthritis, gouty arthritis, postseptic arthritis)
• High-risk medical comorbid patient
• The patient who was planed for simultaneous bilateral TKAs
• The patient who had history of thromboembolic disease or bleeding disorder
• The patient who was receiving anticoagulant drug treatment
• The patient who had allergy to tranexamic acid

Sponsors & Collaborators

• Mahidol University: lead

Related Publications (1)

• Chareancholvanich K, Siriwattanasakul P, Narkbunnam R, Pornrattanamaneewong C. Temporary clamping of drain combined with tranexamic acid reduce blood loss after total knee arthroplasty: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2012 Jul 20;13:124. doi: 10.1186/1471-2474-13-124.

  PMID: 22817651 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Keerati Charoencholvanich, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 5, 2011
• First Posted: October 10, 2011
• Study Start: June 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2008
• Last Updated: November 7, 2011

Record last verified: 2011-11