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Lack of patient enrollment due to only one surgeon that was enrolling.
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| Name | Class |
|---|---|
| Winthrop University Hospital | OTHER |
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This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).
Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions.
In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients.
Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted.
Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Tranexamic Acid | Experimental |
|
|
| Intravenous Placebo | Placebo Comparator | - IV 0.9% sterile saline |
|
| Intravenous Tranexamic Acid followed by Intravenous Placebo | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Placebo | Drug | IV 0.9% sterile saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Required a Blood Transfusion During Surgery | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | operative period (average of 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Levels of Hematocrit: Pre-operative to Post-operative | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Day 3 or 4 post surgery |
| Length of Hospital Stay |
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Inclusion Criteria
Exclusion Criteria for IV TXA administration
Criteria for Use of Topical TXA
Absolute Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jan A Koenig, M.D. | Winthrop University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17403800 | Background | Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222. | |
| 9973048 | Background | Bierbaum BE, Callaghan JJ, Galante JO, Rubash HE, Tooms RE, Welch RB. An analysis of blood management in patients having a total hip or knee arthroplasty. J Bone Joint Surg Am. 1999 Jan;81(1):2-10. doi: 10.2106/00004623-199901000-00002. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Tranexamic Acid |
Intravenous Tranexamic Acid: 1g TXA IVPB |
| FG001 | Intravenous Placebo | - IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline |
| FG002 | Intravenous Tranexamic Acid Followed by Intravenous Placebo |
Intravenous Placebo: IV 0.9% sterile saline Intravenous Tranexamic Acid: 1g TXA IVPB |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Tranexamic Acid |
Intravenous Tranexamic Acid: 1g TXA IVPB |
| BG001 | Intravenous Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Who Required a Blood Transfusion During Surgery | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Posted | operative period (average of 1 hour) |
|
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Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
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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 | Intravenous Tranexamic Acid |
Intravenous Tranexamic Acid: 1g TXA IVPB |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jan Koenig | NYU Langone | 516-678-2232 | Jan.Koenig@nyulangone.org |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Intravenous Tranexamic Acid | Drug | 1g TXA IVPB (intravenous piggyback) |
|
|
Measured in Days |
| At Hospital Discharge |
| Estimated Blood Loss During Surgery | Surgeon estimated blood loss | Operative period (an average of 1 hour) |
| Change in Hemoglobin: Pre-operative to Post-operative | Measured in grams/deciliter | Day 3 or 4 post surgery |
| Walking Distance Post Total Joint Arthroplasty of the Hip | Walking distance (feet) will be assessed and documented throughout the hospital stay | 4 Days |
| 20040083 | Background | Pedersen AB, Mehnert F, Overgaard S, Johnsen SP. Allogeneic blood transfusion and prognosis following total hip replacement: a population-based follow up study. BMC Musculoskelet Disord. 2009 Dec 29;10:167. doi: 10.1186/1471-2474-10-167. |
| 22611164 | Background | Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054. |
| 21196541 | Background | Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984. |
| 23815893 | Background | Panteli M, Papakostidis C, Dahabreh Z, Giannoudis PV. Topical tranexamic acid in total knee replacement: a systematic review and meta-analysis. Knee. 2013 Oct;20(5):300-9. doi: 10.1016/j.knee.2013.05.014. Epub 2013 Jun 28. |
| 16487712 | Background | Orpen NM, Little C, Walker G, Crawfurd EJ. Tranexamic acid reduces early post-operative blood loss after total knee arthroplasty: a prospective randomised controlled trial of 29 patients. Knee. 2006 Mar;13(2):106-10. doi: 10.1016/j.knee.2005.11.001. Epub 2006 Feb 17. |
| 16156456 | Background | Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9. |
| 16470437 | Background | Niskanen RO, Korkala OL. Tranexamic acid reduces blood loss in cemented hip arthroplasty: a randomized, double-blind study of 39 patients with osteoarthritis. Acta Orthop. 2005 Dec;76(6):829-32. doi: 10.1080/17453670510045444. |
| 11476309 | Background | Tanaka N, Sakahashi H, Sato E, Hirose K, Ishima T, Ishii S. Timing of the administration of tranexamic acid for maximum reduction in blood loss in arthroplasty of the knee. J Bone Joint Surg Br. 2001 Jul;83(5):702-5. doi: 10.1302/0301-620x.83b5.11745. |
| 18067499 | Background | Alvarez JC, Santiveri FX, Ramos I, Vela E, Puig L, Escolano F. Tranexamic acid reduces blood transfusion in total knee arthroplasty even when a blood conservation program is applied. Transfusion. 2008 Mar;48(3):519-25. doi: 10.1111/j.1537-2995.2007.01564.x. Epub 2007 Dec 7. |
| 16531440 | Background | Camarasa MA, Olle G, Serra-Prat M, Martin A, Sanchez M, Ricos P, Perez A, Opisso L. Efficacy of aminocaproic, tranexamic acids in the control of bleeding during total knee replacement: a randomized clinical trial. Br J Anaesth. 2006 May;96(5):576-82. doi: 10.1093/bja/ael057. Epub 2006 Mar 10. |
| 24385043 | Background | Chang CH, Chang Y, Chen DW, Ueng SW, Lee MS. Topical tranexamic acid reduces blood loss and transfusion rates associated with primary total hip arthroplasty. Clin Orthop Relat Res. 2014 May;472(5):1552-7. doi: 10.1007/s11999-013-3446-0. Epub 2014 Jan 3. |
| 24238825 | Background | Martin JG, Cassatt KB, Kincaid-Cinnamon KA, Westendorf DS, Garton AS, Lemke JH. Topical administration of tranexamic acid in primary total hip and total knee arthroplasty. J Arthroplasty. 2014 May;29(5):889-94. doi: 10.1016/j.arth.2013.10.005. Epub 2013 Oct 16. |
| 23906869 | Background | Georgiadis AG, Muh SJ, Silverton CD, Weir RM, Laker MW. A prospective double-blind placebo controlled trial of topical tranexamic acid in total knee arthroplasty. J Arthroplasty. 2013 Sep;28(8 Suppl):78-82. doi: 10.1016/j.arth.2013.03.038. Epub 2013 Jul 29. |
| 23886406 | Background | Konig G, Hamlin BR, Waters JH. Topical tranexamic acid reduces blood loss and transfusion rates in total hip and total knee arthroplasty. J Arthroplasty. 2013 Oct;28(9):1473-6. doi: 10.1016/j.arth.2013.06.011. Epub 2013 Jul 23. |
| 23790499 | Background | Wind TC, Barfield WR, Moskal JT. The effect of tranexamic acid on transfusion rate in primary total hip arthroplasty. J Arthroplasty. 2014 Feb;29(2):387-9. doi: 10.1016/j.arth.2013.05.026. Epub 2013 Jun 21. |
| 24095586 | Background | Gilbody J, Dhotar HS, Perruccio AV, Davey JR. Topical tranexamic acid reduces transfusion rates in total hip and knee arthroplasty. J Arthroplasty. 2014 Apr;29(4):681-4. doi: 10.1016/j.arth.2013.09.005. Epub 2013 Oct 4. |
| 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. |
| 22814857 | Background | Gillette BP, DeSimone LJ, Trousdale RT, Pagnano MW, Sierra RJ. Low risk of thromboembolic complications with tranexamic acid after primary total hip and knee arthroplasty. Clin Orthop Relat Res. 2013 Jan;471(1):150-4. doi: 10.1007/s11999-012-2488-z. |
| 23540893 | Background | Fu DJ, Chen C, Guo L, Yang L. Use of intravenous tranexamic acid in total knee arthroplasty: a meta-analysis of randomized controlled trials. Chin J Traumatol. 2013;16(2):67-76. |
| 22623147 | Background | Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873. |
- IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline |
| BG002 | Intravenous Tranexamic Acid Followed by Intravenous Placebo |
Intravenous Placebo: IV 0.9% sterile saline Intravenous Tranexamic Acid: 1g TXA IVPB |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Pre-operative hemoglobin | Median | Standard Deviation | grams/decileter (g/dl) |
|
| Pre-operative hematocrit | Mean | Standard Deviation | percentage of red blood cells |
|
- IV 0.9% sterile saline
Intravenous Placebo: IV 0.9% sterile saline
| OG002 | Intravenous Tranexamic Acid Followed by Intravenous Placebo |
Intravenous Placebo: IV 0.9% sterile saline Intravenous Tranexamic Acid: 1g TXA IVPB |
|
| Secondary | Change in Levels of Hematocrit: Pre-operative to Post-operative | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Posted | Day 3 or 4 post surgery |
|
|
| Secondary | Length of Hospital Stay | Measured in Days | Posted | Mean | 95% Confidence Interval | Days | At Hospital Discharge |
|
|
|
| Secondary | Estimated Blood Loss During Surgery | Surgeon estimated blood loss | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Posted | Operative period (an average of 1 hour) |
|
|
| Secondary | Change in Hemoglobin: Pre-operative to Post-operative | Measured in grams/deciliter | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Posted | Day 3 or 4 post surgery |
|
|
| Secondary | Walking Distance Post Total Joint Arthroplasty of the Hip | Walking distance (feet) will be assessed and documented throughout the hospital stay | Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available. | Posted | 4 Days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Intravenous Placebo | - IV 0.9% sterile saline Intravenous Placebo: IV 0.9% sterile saline | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Intravenous Tranexamic Acid Followed by Intravenous Placebo |
Intravenous Placebo: IV 0.9% sterile saline Intravenous Tranexamic Acid: 1g TXA IVPB | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017670 |
| Sodium Compounds |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |