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Trial record 15 of 34 for:    "Collagen Disease" | "Tranexamic Acid"

Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT01850394
Recruitment Status : Completed
First Posted : May 9, 2013
Results First Posted : December 13, 2013
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Viroj Kawinwonggowit, Mahidol University

Brief Summary:
The purpose of this study is to determine 1) the effective dosage of intra-articular tranexamic acid injection for controlling blood loss and blood transfusion requirement in conventional total knee replacement, and 2) whether the blood loss reduction effect depended on the dose of tranexamic acid used.

Condition or disease Intervention/treatment Phase
Primary Osteoarthritis of Knee Nos Drug: Tranexamic Acid Drug: Physiologic saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Placebo Comparator: Control group
physiologic saline 25 ml
Drug: Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Active Comparator: TXA-250 group
A total of 25-ml solution with 250-mg tranexamic acid
Drug: Tranexamic Acid
Inject tranexamic acid solution intra-articularly after fascia closure
Other Name: Transmin

Drug: Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group

Active Comparator: TXA-500 group
A total of 25-ml solution with 500-mg tranexamic acid
Drug: Tranexamic Acid
Inject tranexamic acid solution intra-articularly after fascia closure
Other Name: Transmin

Drug: Physiologic saline
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group




Primary Outcome Measures :
  1. Perioperative Blood Loss [ Time Frame: 5 days after surgery ]
    • Drainage blood loss measured by accumulating total drainage volume postoperatively
    • Calculated total blood loss measured by using specific formula and difference between hematocrit preoperatively and the fourth postoperative day

  2. Total Hemoglobin Loss [ Time Frame: 5 days after surgery ]
    Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day


Secondary Outcome Measures :
  1. Knee Function Scores [ Time Frame: 1 year after surgery ]

    Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period.

    1. Knee Society Knee Score using for rating knee function measurement and subdivided into two parts; knee score and function score 1.1. Knee score : calculated from pain, presence of deformity, total range of flexion, alignment, and stability. Total score is 100 (0-100), more score means better.

      1.2. Function score : calculated from patient's ability to walk and climb stairs. The score ranges from 0-100, more score means better.

    2. Western Ontario and McMaster Universities Arthritis Index or WOMAC score : a widely used, standardized questionnaires for evaluating the condition of patients with knee osteoarthritis, including pain (score = 0-20), stiffness (0-8), and functional limitation (0-68). Total score ranges from 0-68, lower score means better.

  2. Number of Patients Required Blood Transfusion [ Time Frame: postoperative period (5 days after surgery) ]
  3. Number of Patients Having Postoperative Complications [ Time Frame: postoperative 1-year period ]

    Postoperative complications were measured as an incidence of the following complications;

    • wound hematoma
    • surgical site infection
    • systemic infection
    • deep vein thrombosis
    • pulmonary embolism
    • knee stiffness requiring manipulation
    • medical complication such as myocardial infarction, congestive hear failure



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients diagnosed as primary knee osteoarthritis and underwent unilateral primary cemented conventional total knee replacement
  • no risk of abnormal bleeding tendency or bleeding disorder (normal coagulogram, serum creatinine < 2.0 mg/dL, stop nonsteroidal anti-inflammatory drugs and antiplatelet drugs more than 7 days
  • no contra-indication for tranexamic acid use (no active intravascular clotting process, no acquired defective colour vision, no subarachnoid hemorrhage, no hypersensitivity to TXA, and no any of history of serious adverse effects, thrombotic disorder and hematuria)

Exclusion Criteria:

  • incomplete data collection, for example, malfunctioned drain or accidental drain removal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850394


Locations
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Thailand
Ramathibodi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Viroj Kawinwonggowit, Clinical Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01850394     History of Changes
Other Study ID Numbers: ID 01-53-06
First Posted: May 9, 2013    Key Record Dates
Results First Posted: December 13, 2013
Last Update Posted: December 13, 2013
Last Verified: October 2013

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