Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
116 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-09-30
Study Completion Date
2016-02-29
Brief Summary
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To the Investigators' knowledge, TXA has not been studied in the setting of reverse total shoulder arthroplasty. We propose a double-blinded, randomized, controlled trial comparing perioperative administration of TXA to placebo in the setting of RTSA. The purpose of this study is to examine the efficacy of TXA in reducing overall blood loss and transfusion rates in patients undergoing reverse total shoulder arthroplasty.
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Detailed Description
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Shoulder arthroplasty is a procedure used to relieve pain and dysfunction associated with arthritic destruction of the gleno-humeral joint. It has been demonstrated that in patients with concomitant rotator cuff deficiency, reverse total shoulder arthroplasty (rTSA) is an efficacious procedure that relieves pain as well as increases the lever-arm of the deltoid muscle, thus improving post-operative strength and range of motion.
However, perioperative blood loss in total shoulder arthroplasty can be significant, with an overall rate of allogeneic blood transfusion reported to be 7.4%-43% \[1-5\]. Patients undergoing reverse total shoulder arthroplasty are at even further risk of requiring a postoperative blood transfusion \[2\]. Blood transfusions are associated with significant risks to patient health that range from mild to life threatening.
Tranexamic acid (TXA) is an antifibrinolytic medication (reduces the destruction of blood clots, thus promoting the ability to stop bleeding) that is frequently used to reduce perioperative blood loss, blood transfusions and associated costs in major cardiac, vascular, obstetric, and orthopedic procedures. Currently, TXA is increasingly used in orthopedic joint reconstructive surgery and has proven to be safe and effective in reducing blood loss following total knee arthroplasty (TKA) and total hip arthroplasty (THA) \[11-33\]. Multiple recent meta-analyses have found that use of TXA in the setting of TKA and THA leads to significantly less overall blood loss and lower rates of blood transfusion without increasing rates of venous thromboembolism (VTE) or other complications \[34-37\]. TXA is now on formulary at William Beaumont Hospital.
100 patients slated to undergo elective reverse total shoulder arthroplasty will be recruited and randomized to receive either an infusion of the standard dose of TXA (10mg/kg) or placebo (an equivalent volume of normal saline) within 60 minutes prior to surgery and at wound closure.
Adult subjects 18 years of age or older will participate in this study after the objectives, methods, and potential hazards of the study have been fully explained, and after they have signed the informed consent form. The Investigator or designee is responsible for keeping a record of all subjects who sign an informed consent form for entry into this study
DATA AND SAFETY MONITORING PLAN Beaumont Research will follow their standard operating policy and procedure for establishing a group of designated Beaumont Hospital faculty that will be responsible for data and safety monitoring. This group will include a clinician, physician, scientific member and statistician. They will meet twice throughout the course of the study. A medical monitor was not appointed since this is a single-site study; Dr. J. Michael Wiater will personally oversee the health and well-being of all patients and submit AE reports, and the designated group will directly review all adverse event reports. Beaumont's Human Investigation Committee will review the data safety monitoring plan as part of their IRB approval process.
Study data will be transcribed by study personnel from the source documents into an electronic database maintained in Excel. The data collections forms are to be completed by the research nurse at the time of the data collection so that they always reflect the latest observations on the subjects participating in the study. Demographic data will be filled in preoperatively, intraoperative blood loss will be recorded in the OR, postoperative blood loss and transfusion will be collected retrospectively, and complications will be recorded as they occur or at 2 and 6 week follow-up. All data entries, corrections and alterations must be made by the investigator or other authorized study personnel. The Research Institute will complete internal auditing at random intervals during the study for data integrity, proper informed consent process implementation and documentation, protocol adherence, and patient safety reporting compliance to regulatory bodies.
Descriptive statistics will be provided for all data collected. Missing data will remain missing and will not be replaced by substitutions or interpolations. Statistical software (SPSS, IBM, Inc) will be used for all analyses. Baseline and demographic data will be compared between the 2 randomization arms to determine if any imbalances exist. Categorical variables will be shown as counts and % frequencies. They will be examined using Pearson's Chi-square where appropriate (expected frequency\>5), otherwise a Fisher's Exact test will be used. Continuous variables will be examined for normality. Normally distributed variables will be analyzed using t-tests and non-normally distributed variables will be examined using non-parametric Wilcoxon rank tests. All continuous variables will be shown as means+/- the standard deviation followed by the median and (25th, 75th percentiles) where needed.
The primary outcome of intraoperative and postoperative blood loss and postoperative drop in Hb will be examined for normality. Normally distributed variables will be analyzed using t-tests and non-normally distributed variables will be examined using non-parametric Wilcoxon rank tests. Total number of postoperative transfusions and total number of patients requiring postoperative transfusions will be shown as counts and % frequencies. They will be examined using Pearson's Chi-square where appropriate (expected frequency\>5), otherwise a Fisher's Exact test will be used.
The secondary outcomes of systemic and surgical site complications will be examined between the two randomization arms using Pearson's Chi-square where appropriate (expected frequency\>5), otherwise a Fisher's Exact test will be used.
However, perioperative blood loss in total shoulder arthroplasty can be significant, with an overall rate of allogeneic blood transfusion reported to be 7.4%-43% \[1-5\]. Patients undergoing reverse total shoulder arthroplasty are at even further risk of requiring a postoperative blood transfusion \[2\]. Blood transfusions are associated with significant risks to patient health that range from mild to life threatening.
Tranexamic acid (TXA) is an antifibrinolytic medication (reduces the destruction of blood clots, thus promoting the ability to stop bleeding) that is frequently used to reduce perioperative blood loss, blood transfusions and associated costs in major cardiac, vascular, obstetric, and orthopedic procedures. Currently, TXA is increasingly used in orthopedic joint reconstructive surgery and has proven to be safe and effective in reducing blood loss following total knee arthroplasty (TKA) and total hip arthroplasty (THA) \[11-33\]. Multiple recent meta-analyses have found that use of TXA in the setting of TKA and THA leads to significantly less overall blood loss and lower rates of blood transfusion without increasing rates of venous thromboembolism (VTE) or other complications \[34-37\]. TXA is now on formulary at William Beaumont Hospital.
100 patients slated to undergo elective reverse total shoulder arthroplasty will be recruited and randomized to receive either an infusion of the standard dose of TXA (10mg/kg) or placebo (an equivalent volume of normal saline) within 60 minutes prior to surgery and at wound closure.
Adult subjects 18 years of age or older will participate in this study after the objectives, methods, and potential hazards of the study have been fully explained, and after they have signed the informed consent form. The Investigator or designee is responsible for keeping a record of all subjects who sign an informed consent form for entry into this study
DATA AND SAFETY MONITORING PLAN Beaumont Research will follow their standard operating policy and procedure for establishing a group of designated Beaumont Hospital faculty that will be responsible for data and safety monitoring. This group will include a clinician, physician, scientific member and statistician. They will meet twice throughout the course of the study. A medical monitor was not appointed since this is a single-site study; Dr. J. Michael Wiater will personally oversee the health and well-being of all patients and submit AE reports, and the designated group will directly review all adverse event reports. Beaumont's Human Investigation Committee will review the data safety monitoring plan as part of their IRB approval process.
Study data will be transcribed by study personnel from the source documents into an electronic database maintained in Excel. The data collections forms are to be completed by the research nurse at the time of the data collection so that they always reflect the latest observations on the subjects participating in the study. Demographic data will be filled in preoperatively, intraoperative blood loss will be recorded in the OR, postoperative blood loss and transfusion will be collected retrospectively, and complications will be recorded as they occur or at 2 and 6 week follow-up. All data entries, corrections and alterations must be made by the investigator or other authorized study personnel. The Research Institute will complete internal auditing at random intervals during the study for data integrity, proper informed consent process implementation and documentation, protocol adherence, and patient safety reporting compliance to regulatory bodies.
Descriptive statistics will be provided for all data collected. Missing data will remain missing and will not be replaced by substitutions or interpolations. Statistical software (SPSS, IBM, Inc) will be used for all analyses. Baseline and demographic data will be compared between the 2 randomization arms to determine if any imbalances exist. Categorical variables will be shown as counts and % frequencies. They will be examined using Pearson's Chi-square where appropriate (expected frequency\>5), otherwise a Fisher's Exact test will be used. Continuous variables will be examined for normality. Normally distributed variables will be analyzed using t-tests and non-normally distributed variables will be examined using non-parametric Wilcoxon rank tests. All continuous variables will be shown as means+/- the standard deviation followed by the median and (25th, 75th percentiles) where needed.
The primary outcome of intraoperative and postoperative blood loss and postoperative drop in Hb will be examined for normality. Normally distributed variables will be analyzed using t-tests and non-normally distributed variables will be examined using non-parametric Wilcoxon rank tests. Total number of postoperative transfusions and total number of patients requiring postoperative transfusions will be shown as counts and % frequencies. They will be examined using Pearson's Chi-square where appropriate (expected frequency\>5), otherwise a Fisher's Exact test will be used.
The secondary outcomes of systemic and surgical site complications will be examined between the two randomization arms using Pearson's Chi-square where appropriate (expected frequency\>5), otherwise a Fisher's Exact test will be used.
Conditions
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Shoulder Joint Disease
Complications; Arthroplasty
Intraoperative Complications
Blood Loss, Surgical
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Tranexamic acid
Infusion Tranexamic acid on study subjects. They will be randomized to receive an infusion of the standard dose of Tranexamic acid (10mg/kg) One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Group Type
ACTIVE_COMPARATOR
Tranexamic Acid
Intervention Type
DRUG
Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
Normal Saline
Infusion of placebo on study subjects. They will be randomized to receive an infusion of placebo (an equivalent volume of normal saline). One dose will be given by the bedside nurse within 60 minutes prior to surgery and a second dose will be given at wound closure. Infusion will be given along with standard preoperative and operative infusion; no additional infusion will be necessary.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
Interventions
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Tranexamic Acid
Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
Intervention Type
DRUG
Placebo
Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
Intervention Type
DRUG
Other Intervention Names
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TXA
Antifibrinolytic
Normal Saline
Eligibility Criteria
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Inclusion Criteria
1. Patients undergoing scheduled primary reverse total shoulder arthroplasty performed by J. Michael Wiater, MD.
2. Patients age 18 and older
2. Patients age 18 and older
Exclusion Criteria
1. Pregnant\* or breast-feeding women
2. Allergy to tranexamic acid
3. Acquired disturbances of color vision
4. Use of estrogen containing medications (i.e. oral contraceptive pills)
5. Hormone replacement therapy
6. Preoperative anemia \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\]
7. Refusal of blood products
8. Preoperative use of anticoagulant therapy within 5 days prior to surgery
1. Coumadin
2. Heparin
3. Low molecular weight heparin
4. Factor Xa inhibitors
9. Thrombin inhibitors
10. Coagulopathy
11. Thrombophilia
12. Antithrombin deficiency
13. Factor V Leiden
14. Antiphospholipid Syndrome
15. Protein C and S deficiency
16. History of heparin induced thrombocytopenia
17. Sickle cell anemia
18. Myeloproliferative disorders
19. Platelet \< 150,00 mm3
20. International Normalized Ratio (INR) \> 1.4
21. Partial Thromboplastin Time (PTT) \> 1.4 times normal
22. A history of arterial or venous thromboembolism
23. Cerebral Vascular Accident
24. Deep Vein Thrombosis
25. Pulmonary Embolism
26. Subarachnoid hemorrhage
27. Active intravascular clotting
28. Major comorbidities
29. Coronary artery disease (New York Heart Association Class III or IV)
30. Previous MI
31. Severe pulmonary disease (FEV \<50% normal)
32. Plasma creatinine \> 115 μmol/L in males, \> 100 μmol/L in females, or hepatic failure)
34\. Participation in another clinical trial 35. \*All women of child bearing potential must have a negative serum or urine pregnancy test.
2. Allergy to tranexamic acid
3. Acquired disturbances of color vision
4. Use of estrogen containing medications (i.e. oral contraceptive pills)
5. Hormone replacement therapy
6. Preoperative anemia \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\]
7. Refusal of blood products
8. Preoperative use of anticoagulant therapy within 5 days prior to surgery
1. Coumadin
2. Heparin
3. Low molecular weight heparin
4. Factor Xa inhibitors
9. Thrombin inhibitors
10. Coagulopathy
11. Thrombophilia
12. Antithrombin deficiency
13. Factor V Leiden
14. Antiphospholipid Syndrome
15. Protein C and S deficiency
16. History of heparin induced thrombocytopenia
17. Sickle cell anemia
18. Myeloproliferative disorders
19. Platelet \< 150,00 mm3
20. International Normalized Ratio (INR) \> 1.4
21. Partial Thromboplastin Time (PTT) \> 1.4 times normal
22. A history of arterial or venous thromboembolism
23. Cerebral Vascular Accident
24. Deep Vein Thrombosis
25. Pulmonary Embolism
26. Subarachnoid hemorrhage
27. Active intravascular clotting
28. Major comorbidities
29. Coronary artery disease (New York Heart Association Class III or IV)
30. Previous MI
31. Severe pulmonary disease (FEV \<50% normal)
32. Plasma creatinine \> 115 μmol/L in males, \> 100 μmol/L in females, or hepatic failure)
34\. Participation in another clinical trial 35. \*All women of child bearing potential must have a negative serum or urine pregnancy test.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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William Beaumont Hospitals
OTHER
Sponsor Role
lead
Responsible Party
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Michael Wiater
MD
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Michael J Wiater, M.D.
Role: PRINCIPAL_INVESTIGATOR
William Beaumont Hospitals
Kevin Baker, PhD
Role: STUDY_DIRECTOR
William Beaumont Hospitals
Locations
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William Beaumont Hospital
Royal Oak, Michigan, United States
Site Status
Countries
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United States
References
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Hardy JC, Hung M, Snow BJ, Martin CL, Tashjian RZ, Burks RT, Greis PE. Blood transfusion associated with shoulder arthroplasty. J Shoulder Elbow Surg. 2013 Feb;22(2):233-9. doi: 10.1016/j.jse.2012.04.013. Epub 2012 Aug 29.
Reference Type
BACKGROUND
Gruson KI, Accousti KJ, Parsons BO, Pillai G, Flatow EL. Transfusion after shoulder arthroplasty: an analysis of rates and risk factors. J Shoulder Elbow Surg. 2009 Mar-Apr;18(2):225-30. doi: 10.1016/j.jse.2008.08.005. Epub 2008 Dec 31.
Reference Type
BACKGROUND
Schumer RA, Chae JS, Markert RJ, Sprott D, Crosby LA. Predicting transfusion in shoulder arthroplasty. J Shoulder Elbow Surg. 2010 Jan;19(1):91-6. doi: 10.1016/j.jse.2009.05.001.
Reference Type
BACKGROUND
Millett PJ, Porramatikul M, Chen N, Zurakowski D, Warner JJ. Analysis of transfusion predictors in shoulder arthroplasty. J Bone Joint Surg Am. 2006 Jun;88(6):1223-30. doi: 10.2106/JBJS.E.00706.
Reference Type
BACKGROUND
Sperling JW, Duncan SF, Cofield RH, Schleck CD, Harmsen WS. Incidence and risk factors for blood transfusion in shoulder arthroplasty. J Shoulder Elbow Surg. 2005 Nov-Dec;14(6):599-601. doi: 10.1016/j.jse.2005.03.006.
Reference Type
BACKGROUND
Samama CM. A direct antifibrinolytic agent in major orthopedic surgery. Orthopedics. 2004 Jun;27(6 Suppl):s675-80. doi: 10.3928/0147-7447-20040602-09.
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BACKGROUND
Dunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017.
Reference Type
BACKGROUND
Hardy JF, Desroches J. Natural and synthetic antifibrinolytics in cardiac surgery. Can J Anaesth. 1992 Apr;39(4):353-65. doi: 10.1007/BF03009046.
Reference Type
BACKGROUND
Burry M. The decerebrate patient. J Neurosurg Nurs. 1979 Mar;11(1):6-9. No abstract available.
Reference Type
BACKGROUND
Prentice CR. Basis of antifibrinolytic therapy. J Clin Pathol Suppl (R Coll Pathol). 1980;14:35-40. No abstract available.
Reference Type
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.
Reference Type
BACKGROUND
Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996 May;78(3):434-40.
Reference Type
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.
Reference Type
BACKGROUND
Ellis MH, Fredman B, Zohar E, Ifrach N, Jedeikin R. The effect of tourniquet application, tranexamic acid, and desmopressin on the procoagulant and fibrinolytic systems during total knee replacement. J Clin Anesth. 2001 Nov;13(7):509-13. doi: 10.1016/s0952-8180(01)00319-1.
Reference Type
BACKGROUND
Good L, Peterson E, Lisander B. Tranexamic acid decreases external blood loss but not hidden blood loss in total knee replacement. Br J Anaesth. 2003 May;90(5):596-9. doi: 10.1093/bja/aeg111.
Reference Type
BACKGROUND
Hiippala ST, Strid LJ, Wennerstrand MI, Arvela JV, Niemela HM, Mantyla SK, Kuisma RP, Ylinen JE. Tranexamic acid radically decreases blood loss and transfusions associated with total knee arthroplasty. Anesth Analg. 1997 Apr;84(4):839-44. doi: 10.1097/00000539-199704000-00026.
Reference Type
BACKGROUND
Jansen AJ, Andreica S, Claeys M, D'Haese J, Camu F, Jochmans K. Use of tranexamic acid for an effective blood conservation strategy after total knee arthroplasty. Br J Anaesth. 1999 Oct;83(4):596-601. doi: 10.1093/bja/83.4.596.
Reference Type
BACKGROUND
Kakar PN, Gupta N, Govil P, Shah V. Efficacy and Safety of Tranexamic Acid in Control of Bleeding Following TKR: A Randomized Clinical Trial. Indian J Anaesth. 2009 Dec;53(6):667-71.
Reference Type
BACKGROUND
MacGillivray RG, Tarabichi SB, Hawari MF, Raoof NT. Tranexamic acid to reduce blood loss after bilateral total knee arthroplasty: a prospective, randomized double blind study. J Arthroplasty. 2011 Jan;26(1):24-8. doi: 10.1016/j.arth.2009.11.013. Epub 2010 Feb 19.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Veien M, Sorensen JV, Madsen F, Juelsgaard P. Tranexamic acid given intraoperatively reduces blood loss after total knee replacement: a randomized, controlled study. Acta Anaesthesiol Scand. 2002 Nov;46(10):1206-11. doi: 10.1034/j.1399-6576.2002.461007.x.
Reference Type
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.
Reference Type
BACKGROUND
Zhang F, Gao Z, Yu J. [Clinical comparative studies on effect of tranexamic acid on blood loss associated with total knee arthroplasty]. Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2007 Dec;21(12):1302-4. Chinese.
Reference Type
BACKGROUND
Claeys MA, Vermeersch N, Haentjens P. Reduction of blood loss with tranexamic acid in primary total hip replacement surgery. Acta Chir Belg. 2007 Jul-Aug;107(4):397-401. doi: 10.1080/00015458.2007.11680081.
Reference Type
BACKGROUND
Ido K, Neo M, Asada Y, Kondo K, Morita T, Sakamoto T, Hayashi R, Kuriyama S. Reduction of blood loss using tranexamic acid in total knee and hip arthroplasties. Arch Orthop Trauma Surg. 2000;120(9):518-20. doi: 10.1007/s004029900132.
Reference Type
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.
Reference Type
BACKGROUND
Garneti N, Field J. Bone bleeding during total hip arthroplasty after administration of tranexamic acid. J Arthroplasty. 2004 Jun;19(4):488-92. doi: 10.1016/j.arth.2003.12.073.
Reference Type
BACKGROUND
Benoni G, Fredin H, Knebel R, Nilsson P. Blood conservation with tranexamic acid in total hip arthroplasty: a randomized, double-blind study in 40 primary operations. Acta Orthop Scand. 2001 Oct;72(5):442-8. doi: 10.1080/000164701753532754.
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BACKGROUND
Ekback G, Axelsson K, Ryttberg L, Edlund B, Kjellberg J, Weckstrom J, Carlsson O, Schott U. Tranexamic acid reduces blood loss in total hip replacement surgery. Anesth Analg. 2000 Nov;91(5):1124-30. doi: 10.1097/00000539-200011000-00014.
Reference Type
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.
Reference Type
BACKGROUND
Lemay E, Guay J, Cote C, Roy A. Tranexamic acid reduces the need for allogenic red blood cell transfusions in patients undergoing total hip replacement. Can J Anaesth. 2004 Jan;51(1):31-7. doi: 10.1007/BF03018543.
Reference Type
BACKGROUND
Yamasaki S, Masuhara K, Fuji T. Tranexamic acid reduces blood loss after cementless total hip arthroplasty-prospective randomized study in 40 cases. Int Orthop. 2004 Apr;28(2):69-73. doi: 10.1007/s00264-003-0511-4. Epub 2003 Oct 10.
Reference Type
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.
Reference Type
BACKGROUND
Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989.
Reference Type
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.
Reference Type
BACKGROUND
Kagoma YK, Crowther MA, Douketis J, Bhandari M, Eikelboom J, Lim W. Use of antifibrinolytic therapy to reduce transfusion in patients undergoing orthopedic surgery: a systematic review of randomized trials. Thromb Res. 2009 Mar;123(5):687-96. doi: 10.1016/j.thromres.2008.09.015. Epub 2008 Nov 12.
Reference Type
BACKGROUND
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
Reference Type
BACKGROUND
Brecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. doi: 10.1046/j.1537-2995.1997.371098016448.x.
Reference Type
BACKGROUND
Aderinto J, Brenkel IJ. Pre-operative predictors of the requirement for blood transfusion following total hip replacement. J Bone Joint Surg Br. 2004 Sep;86(7):970-3. doi: 10.1302/0301-620x.86b7.14682.
Reference Type
BACKGROUND
Other Identifiers
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2013-060
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
NA
TRANEXAMIC ACID IN PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY IN A BRAZILIAN REFERENCE ORTHOPEDIC CENTER: A RANDOMIZED CONTROLLED TRIAL
NCT03019198
COMPLETED
PHASE4
Topical and Intravenous Administration of TXA Are Equally Effective in DAA THA
NCT01940692
COMPLETED
PHASE2
Topical Tranexamic Acid (TXA) in Joint Arthroplasty
NCT01937559
COMPLETED
PHASE4
The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty
NCT02504125
COMPLETED
PHASE4
Arthroscopic Shoulder Surgery With Administration of Intravenous Tranexamic Acid
NCT04025736
COMPLETED
NA
Efficacy and Safety of Retrograde Intraarticular Injection, Topical Soaking of Tranexamic Acid (TXA), or Placebo in Femoral Neck Fractured Patients Undergoing Cementless Bipolar Hemiarthroplasty
NCT06289478
RECRUITING
NA
Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty
NCT03825939
TERMINATED
PHASE4
Effects of IV Tranexamic Acid on the Thromboelastogram in Patients Undergoing Total Hip or Knee Arthroplasty
NCT02648295
COMPLETED
Tranexamic Acid in Total Hip Arthroplasty.
NCT02252497
COMPLETED
PHASE4
Study Comparing Topical Versus Intravenous Tranexamic Acid in Anterior Total Hip Arthroplasty
NCT03359525
UNKNOWN
PHASE4
Topical Versus Intravenous Tranexamic Acid in Total Knee Arthroplasty
NCT02323373
COMPLETED
PHASE2
The Comparative Efficacy of Peri-articular and Intraarticular Tranexamic Acid in Total Knee Arthroplasty
NCT03074994
UNKNOWN
PHASE2
Intra-articular Tranexamic Acid in the Reduction of Blood Transfusions in Primary Total Hip and Total Knee Arthroplasty
NCT02393963
COMPLETED
PHASE2
Clinical Trial Comparing Tranexamic Acid (TXA) With Aquamantys Sealer in Total Knee Arthroplasty (TKA)
NCT02374398
COMPLETED
PHASE4
Extended Oral Tranexamic Acid After Total Knee Arthroplasty
NCT06618820
ENROLLING_BY_INVITATION
PHASE3
Comparison of Topical and Intravenous Tranexamic Acid in Total Hip Arthroplasty
NCT02312440
COMPLETED
PHASE3
Topical Tranexamic Acid and Acute Blood Loss in Total Knee Arthroplasty
NCT01370460
COMPLETED
PHASE2
Effect on Post-operative Pain of Tranexamic Acid Injection During Shoulder Surgery
NCT05302986
RECRUITING
PHASE3
Tranexamic Acid for Total Knee Arthroscopy
NCT04443920
COMPLETED
PHASE4
Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery
NCT04594408
COMPLETED
PHASE4
The Effect of Tranexamic Acid on Blood Coagulation in Total Hip Arthroplasty Surgery
NCT03897621
COMPLETED
NA
Tranexamic Acid for the Latarjet Procedure.
NCT03458468
COMPLETED
NA