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

NCT ID: NCT01449552

Last Updated: 2011-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2008-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group A

No clamp and placebo

Group Type: EXPERIMENTAL

No clamp and placebo

Intervention Type: 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 B

Tranexamic acid

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: 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 C

Drain clamping

Group Type: EXPERIMENTAL

Drain clamping

Intervention Type: 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 D

Drain clamping and tranexamic acid

Group Type: EXPERIMENTAL

Drain clamping and tranexamic acid

Intervention Type: 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.

Interventions

Tranexamic acid

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.

Intervention Type: DRUG

Drain clamping

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).

Intervention Type: PROCEDURE

Drain clamping and tranexamic acid

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.

Intervention Type: OTHER

No clamp and placebo

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The patients younger than 85 years with knee osteoarthritis

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Keerati Charoencholvanich

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keerati Charoencholvanich, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

References

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.

Reference Type: DERIVED

PMID: 22817651 (View on PubMed)

Other Identifiers

Si463/2007

Identifier Type: -

Identifier Source: org_study_id