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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keerati Charoencholvanich, Mahidol University
ClinicalTrials.gov Identifier:
NCT01449552
First received: October 5, 2011
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Osteoarthritis of Knee
Drug: Tranexamic acid
Procedure: Drain clamping
Other: Drain clamping and tranexamic acid
Other: No clamp and placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Postoperative blood loss [ Time Frame: 48 hours after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of blood transfusion [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 240
Study Start Date: June 2008
Study Completion Date: November 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
No clamp and placebo
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).
Experimental: Group B
Tranexamic acid
Drug: 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.
Experimental: Group C
Drain clamping
Procedure: 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).
Experimental: Group D
Drain clamping and tranexamic acid
Other: 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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449552

Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Keerati Charoencholvanich, MD Mahidol University
  More Information

No publications provided by Mahidol University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Keerati Charoencholvanich, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01449552     History of Changes
Other Study ID Numbers: Si463/2007
Study First Received: October 5, 2011
Last Updated: November 4, 2011
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014