search
Back to results

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

Primary Purpose

Osteoarthritis of Knee

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Drain clamping
Drain clamping and tranexamic acid
No clamp and placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoarthritis of Knee

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Group D

    Arm Description

    No clamp and placebo

    Tranexamic acid

    Drain clamping

    Drain clamping and tranexamic acid

    Outcomes

    Primary Outcome Measures

    Postoperative blood loss

    Secondary Outcome Measures

    Number of blood transfusion

    Full Information

    First Posted
    October 5, 2011
    Last Updated
    November 4, 2011
    Sponsor
    Mahidol University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01449552
    Brief Title
    Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT
    Official Title
    Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis of Knee

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    240 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Experimental
    Arm Description
    No clamp and placebo
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    Tranexamic acid
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    Drain clamping
    Arm Title
    Group D
    Arm Type
    Experimental
    Arm Description
    Drain clamping and tranexamic acid
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid
    Intervention Description
    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
    Procedure
    Intervention Name(s)
    Drain clamping
    Intervention Description
    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
    Other
    Intervention Name(s)
    Drain clamping and tranexamic acid
    Intervention Description
    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
    Intervention Name(s)
    No clamp and placebo
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Postoperative blood loss
    Time Frame
    48 hours after operation
    Secondary Outcome Measure Information:
    Title
    Number of blood transfusion
    Time Frame
    5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Keerati Charoencholvanich, MD
    Organizational Affiliation
    Mahidol University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22817651
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs