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The purpose of this study is to determine if patients undergoing acetabular ORIF (open reduction with internal fixation) who receive tranexamic acid have a reduced risk of allogenic blood transfusion, perioperative blood loss, wound complication and higher risk for thromboembolic events compared to patients who receive placebo. Investigators want to determine the cost-effectiveness related to allogenic blood transfusion as a blood loss management strategy in acetabular open reduction internal fixation (ORIF). Orthopaedic surgery carries with it a significant risk for blood loss. Current management of perioperative blood loss is the use of allogenic blood transfusion. Allogenic blood transfusion carries with it a risk for HIV and Hepatitis C as well as multiple adverse reactions. There have been significant efforts to reduce the use of allogenic blood transfusion in orthopaedic surgery. Tranexamic acid, an anti-fibrinolytic agent, has been used in management of blood during surgery. In order to determine the impact of tranexamic acid in reducing blood loss among patients undergoing acetabular ORIF, investigators will conduct a prospective randomized study. Patients undergoing acetabular surgery will be screened for this study. Patients will be then randomized to placebo or tranexamic acid which will be administered during and after surgery. The following data will be collected: patient characteristics, surgery information, blood loss, blood transfusions, wound complication within 30 days of surgery, and cost.
In this study, investigators plan to prospectively determine the effect of tranexamic acid on blood loss and outcome after surgery to the acetabulum.
Patients will be randomized into two groups. In this study, investigators plan to administer a 10mg/kg dose within 30 minutes of surgery followed by a 10mg/kg infusion over a 4hr period to the treatment group (for patients weighting over 100kg, a weight of 100kg will be used for the dose calculation). The control group will receive equal volumes of and rates of normal saline.
Research Questions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Inactive |
|
| Tranexamic | Active Comparator | Tranexamic acid: anti-fibrinolytic agents |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Tranexamic acid: anti-fibrinolytic agents |
|
| Measure | Description | Time Frame |
|---|---|---|
| Allogenic Blood Transfusion Rates | Number of participant received allogenic blood transfusions. | post-operative |
| Units of Packed Red Blood Cells Transfused | Average units packed red blood cells transfused among participants | perioperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Thromboembolic Event | Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo? | 30 days |
| Estimate Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhav Karunakar, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri | Columbia | Missouri | 65212 | United States | ||
| Carolinas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 742821 | Background | Astedt B, Liedholm P, Wingerup L. The effect of tranexamic acid on the fibrinolytic activity of vein walls. Ann Chir Gynaecol. 1978;67(6):203-5. | |
| 11728069 | 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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undecided
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Inactive Placebo: Placebo |
| FG001 | Tranexamic | Tranexamic acid: anti-fibrinolytic agents Tranexamic Acid: Tranexamic acid: anti-fibrinolytic agents |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Inactive Placebo: Placebo |
| BG001 | Tranexamic | Tranexamic acid: anti-fibrinolytic agents Tranexamic Acid: Tranexamic acid: anti-fibrinolytic agents |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Allogenic Blood Transfusion Rates | Number of participant received allogenic blood transfusions. | Posted | Count of Participants | Participants | post-operative |
|
6 months
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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 | Tranexamic | Patients in the intervention group were administered a 10mg/kg preoperative dose of tranexamic acid within 30 minutes prior to surgery followed by a 10mg/kg infusion over a 4hr period during surgery (for patients weighing over 100kg, a weight of 100kg was used for the dose calculation). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Seymour, PhD | CarolinasHS | 704-355-6969 | Rachel.Seymour@carolinashealthcare.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2013 | Jan 25, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 15, 2013 | Jan 25, 2018 | ICF_001.pdf |
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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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| Placebo | Drug | Placebo |
|
To measure average estimate perioperative blood loss
| perioperative |
| Charlotte |
| North Carolina |
| 28205 |
| United States |
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| Background | Haynes RB, et al. Clinical Epidemiology: How to Do Clinical Practice Research. 3rd ed. Lippincott Williams and Wilkins, 2006. |
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| 11011672 | 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. |
| 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. |
| 19007970 | 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. |
| 15995116 | Background | Karunakar MA, Shah SN, Jerabek S. Body mass index as a predictor of complications after operative treatment of acetabular fractures. J Bone Joint Surg Am. 2005 Jul;87(7):1498-502. doi: 10.2106/JBJS.D.02258. |
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| 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. |
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| 12662278 | Background | Rosencher N, Kerkkamp HE, Macheras G, Munuera LM, Menichella G, Barton DM, Cremers S, Abraham IL; OSTHEO Investigation. Orthopedic Surgery Transfusion Hemoglobin European Overview (OSTHEO) study: blood management in elective knee and hip arthroplasty in Europe. Transfusion. 2003 Apr;43(4):459-69. doi: 10.1046/j.1537-2995.2003.00348.x. |
| Background | Sadeghi M, Mehr-Aein A. Does a single bolus dose of tranexamic acid reduce blood loss and transfusion requirements during hip fracture surgery? A prospective randomized double blind study in 67 patients. Acta Medica Iranica 2007; 45: 437-42. |
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| 19926634 | Background | Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Co-morbidities | Count of Participants | Participants |
|
| Surgical approach | Count of Participants | Participants |
|
| Operative time in minutes | Mean | Standard Deviation | Minutes |
|
| Preoperative Hemoglobin in g/dl | Mean | Standard Deviation | g/dl |
|
| Letournel Fracture Classification | Elementary Type include posterior wall, posterior column, anterior column, anterior wall and transverse acetabular fractures. Associated type include transverse posterior wall, posterior column/posterior wall, anterior column posterior hemitranscerse, t-type and associated both column acetabular fractures. | Count of Participants | Participants |
|
| Orthopaedic Trauma Association Fracture Classification | Count of Participants | Participants |
|
|
|
| Primary | Units of Packed Red Blood Cells Transfused | Average units packed red blood cells transfused among participants | Posted | Mean | Standard Deviation | Units of packed red blood cells | perioperative |
|
|
|
| Secondary | Number of Participants With a Thromboembolic Event | Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo? | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Estimate Blood Loss | To measure average estimate perioperative blood loss | Posted | Mean | Standard Deviation | mL | perioperative |
|
|
|
| 0 |
| 45 |
| 1 |
| 45 |
| 0 |
| 45 |
| EG001 | Placebo | Patients in the control group received an equal volume and rate of normal saline. Patients and providers were blinded with the aid of an investigational drug pharmacy. | 0 | 42 | 0 | 42 | 0 | 42 |
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