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

Primary Purpose

Primary Osteoarthritis of Knee Nos

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Tranexamic Acid
Physiologic saline
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Osteoarthritis of Knee Nos

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Control group

TXA-250 group

TXA-500 group

Arm Description

physiologic saline 25 ml

A total of 25-ml solution with 250-mg tranexamic acid

A total of 25-ml solution with 500-mg tranexamic acid

Outcomes

Primary Outcome Measures

Perioperative Blood Loss
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
Total Hemoglobin Loss
Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day

Secondary Outcome Measures

Knee Function Scores
Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period. 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. 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.
Number of Patients Required Blood Transfusion
Number of Patients Having Postoperative Complications
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

Full Information

First Posted
May 2, 2013
Last Updated
October 24, 2013
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01850394
Brief Title
Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement
Official Title
Efficacy of Low-dose Intra-articular Tranexamic Acid in Total Knee Replacement; A Prospective Triple-blinded Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
physiologic saline 25 ml
Arm Title
TXA-250 group
Arm Type
Active Comparator
Arm Description
A total of 25-ml solution with 250-mg tranexamic acid
Arm Title
TXA-500 group
Arm Type
Active Comparator
Arm Description
A total of 25-ml solution with 500-mg tranexamic acid
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Transmin
Intervention Description
Inject tranexamic acid solution intra-articularly after fascia closure
Intervention Type
Drug
Intervention Name(s)
Physiologic saline
Intervention Description
Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
Primary Outcome Measure Information:
Title
Perioperative Blood Loss
Description
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
Time Frame
5 days after surgery
Title
Total Hemoglobin Loss
Description
Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day
Time Frame
5 days after surgery
Secondary Outcome Measure Information:
Title
Knee Function Scores
Description
Knee function score was measured with 2 methods, and were evaluated preoperatively and then postoperatively at 3-month, 6-month, and 1-year period. 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. 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.
Time Frame
1 year after surgery
Title
Number of Patients Required Blood Transfusion
Time Frame
postoperative period (5 days after surgery)
Title
Number of Patients Having Postoperative Complications
Description
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
Time Frame
postoperative 1-year period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
22053253
Citation
Sa-Ngasoongsong P, Channoom T, Kawinwonggowit V, Woratanarat P, Chanplakorn P, Wibulpolprasert B, Wongsak S, Udomsubpayakul U, Wechmongkolgorn S, Lekpittaya N. Postoperative blood loss reduction in computer-assisted surgery total knee replacement by low dose intra-articular tranexamic acid injection together with 2-hour clamp drain: a prospective triple-blinded randomized controlled trial. Orthop Rev (Pavia). 2011;3(2):e12. doi: 10.4081/or.2011.e12. Epub 2011 Jun 29.
Results Reference
background
PubMed Identifier
21253725
Citation
Ishida K, Tsumura N, Kitagawa A, Hamamura S, Fukuda K, Dogaki Y, Kubo S, Matsumoto T, Matsushita T, Chin T, Iguchi T, Kurosaka M, Kuroda R. Intra-articular injection of tranexamic acid reduces not only blood loss but also knee joint swelling after total knee arthroplasty. Int Orthop. 2011 Nov;35(11):1639-45. doi: 10.1007/s00264-010-1205-3. Epub 2011 Jan 21.
Results Reference
background
PubMed Identifier
21048170
Citation
Wong J, Abrishami A, El Beheiry H, Mahomed NN, Roderick Davey J, Gandhi R, Syed KA, Muhammad Ovais Hasan S, De Silva Y, Chung F. Topical application of tranexamic acid reduces postoperative blood loss in total knee arthroplasty: a randomized, controlled trial. J Bone Joint Surg Am. 2010 Nov 3;92(15):2503-13. doi: 10.2106/JBJS.I.01518.
Results Reference
background
PubMed Identifier
22419350
Citation
Maniar RN, Kumar G, Singhi T, Nayak RM, Maniar PR. Most effective regimen of tranexamic acid in knee arthroplasty: a prospective randomized controlled study in 240 patients. Clin Orthop Relat Res. 2012 Sep;470(9):2605-12. doi: 10.1007/s11999-012-2310-y. Epub 2012 Mar 15.
Results Reference
background
PubMed Identifier
22419263
Citation
Roy SP, Tanki UF, Dutta A, Jain SK, Nagi ON. Efficacy of intra-articular tranexamic acid in blood loss reduction following primary unilateral total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012 Dec;20(12):2494-501. doi: 10.1007/s00167-012-1942-5. Epub 2012 Mar 15.
Results Reference
background
PubMed Identifier
22729012
Citation
Seo JG, Moon YW, Park SH, Kim SM, Ko KR. The comparative efficacies of intra-articular and IV tranexamic acid for reducing blood loss during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1869-74. doi: 10.1007/s00167-012-2079-2. Epub 2012 Jun 24. Erratum In: Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1875.
Results Reference
background
PubMed Identifier
24308672
Citation
Sa-Ngasoongsong P, Wongsak S, Chanplakorn P, Woratanarat P, Wechmongkolgorn S, Wibulpolprasert B, Mulpruek P, Kawinwonggowit V. Efficacy of low-dose intra-articular tranexamic acid in total knee replacement; a prospective triple-blinded randomized controlled trial. BMC Musculoskelet Disord. 2013 Dec 5;14:340. doi: 10.1186/1471-2474-14-340.
Results Reference
derived

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

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