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
About this trial
This is an interventional prevention trial for Osteoarthritis of Knee
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
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
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
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Temporary Clamping of Drains Combined With Tranexamic Acid Reduce Blood Loss After TKA: A Prospective RCT
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