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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | physiologic saline 25 ml |
|
| TXA-250 group | Active Comparator | A total of 25-ml solution with 250-mg tranexamic acid |
|
| TXA-500 group | Active Comparator | A total of 25-ml solution with 500-mg tranexamic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Inject tranexamic acid solution intra-articularly after fascia closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Blood Loss |
| 5 days after surgery |
| Total Hemoglobin Loss | Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day | 5 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22053253 | Background | 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. | |
| 21253725 |
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Seventeen patients were excluded that including refusal to participate (4 patients), serum creatinine more than 2.0 mg% (4 patients), rheumatoid arthritis (4 patients), abnormal coagulogram (3 patients), and history of stroke (2 patients)
The patients, who planned to undergo primary total knee replacement, were recruited from medical clinics before setting the operative schedule between 2009 and 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | physiologic saline 25 ml Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group |
| FG001 | TXA-250 Group | A total of 25-ml solution with 250-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure |
| FG002 | TXA-500 Group | A total of 25-ml solution with 500-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | physiologic saline 25 ml Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group |
| BG001 | TXA-250 Group | A total of 25-ml solution with 250-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perioperative Blood Loss |
| Using intention-to-treat analysis | Posted | Median | Standard Deviation | ml | 5 days after surgery |
|
5 days
Perioperative venous thromboembolic complications
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | physiologic saline 25 ml Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Venous thromboembolic complication | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paphon Sa-ngasoongsong | Faculty of Medicine, Ramathibodi Hospital, Mahidol University | 66-2-2011589 | chan3s@hotmail.com |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Physiologic saline | Drug | Use physiologic saline for mixing with tranexamic acid or use alone in placebo group |
|
| 1 year after surgery |
| Number of Patients Required Blood Transfusion | postoperative period (5 days after surgery) |
| Number of Patients Having Postoperative Complications | Postoperative complications were measured as an incidence of the following complications;
| postoperative 1-year period |
| Background |
| 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. |
| 21048170 | Background | 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. |
| 22419350 | Background | 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. |
| 22419263 | Background | 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. |
| 22729012 | Background | 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. |
| 24308672 | Derived | 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. |
| BG002 | TXA-500 Group | A total of 25-ml solution with 500-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | TXA-500 Group | A total of 25-ml solution with 500-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure |
|
|
|
| Secondary | 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.
| Using intention-to-treat analysis | Posted | Mean | Standard Deviation | units on a scale | 1 year after surgery |
|
|
|
|
| Secondary | Number of Patients Required Blood Transfusion | Posted | Number | participants | postoperative period (5 days after surgery) |
|
|
|
|
| Secondary | Number of Patients Having Postoperative Complications | Postoperative complications were measured as an incidence of the following complications;
| Using Intention-to-treat analysis | Posted | Number | participants | postoperative 1-year period |
|
|
|
|
| Primary | Total Hemoglobin Loss | Total hemoglobin loos measured by difference between hemoglobin preoperatively and the fourth postoperative day | Use intention-to-treat analysis | Posted | Mean | Standard Deviation | g/dL | 5 days after surgery |
|
|
|
|
| 4 |
| 45 |
| 0 |
| 45 |
| EG001 | TXA-250 Group | A total of 25-ml solution with 250-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure | 1 | 45 | 0 | 45 |
| EG002 | TXA-500 Group | A total of 25-ml solution with 500-mg tranexamic acid Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure | 2 | 45 | 0 | 45 |
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|
| <0.05 |
| Mean Difference (Final Values) |
| 15 |
| Standard Deviation |
| 4 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| Title | Measurements |
|---|---|
|
| Venous thromboembolic complication |
|
| Congestive heart failure |
|