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The overall design of the study is a prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
A significant portion of the geriatric hip fracture population have comorbidities including chronic kidney disease, congestive heart failure, ischemic heart disease, stroke, etc. These patients may be anemic prior to the surgery, and are at increased risk for further blood loss as a result of the fracture and surgical operation. However, intra-operative or post-operative blood transfusions also increase the risk of renal and cardiac complications in this population.
Tranexamic acid (TXA) is an anti-fibrinolytic medication that has transformed total joint replacement management regarding blood loss prevention. Geriatric patients requiring emergent hip fracture repair may significantly benefit from routine administration of TXA prior to the procedure to decrease the risk of blood loss. Thus, treatment may further reduce the percentage of patients who experience blood transfusions and complications associated with transfusions.
The investigators will examine if administration of TXA prior to incision in the geriatric hip fracture patient population decreases the risk of intra-operative or post-operative blood transfusions compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 100 cc normal saline with 1g of tranexamic acid in solution |
|
| Placebo | Placebo Comparator | 100 cc normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid Injectable Solution | Drug | 100 cc normal saline mixed with 1g of tranexamic acid in solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells. | Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate | Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery. | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Tocks, DO | Penn Medicine / Lancaster General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lancaster General Heatlh / Penn Medicine | Lancaster | Pennsylvania | 17602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27492116 | Background | Farrow LS, Smith TO, Ashcroft GP, Myint PK. A systematic review of tranexamic acid in hip fracture surgery. Br J Clin Pharmacol. 2016 Dec;82(6):1458-1470. doi: 10.1111/bcp.13079. Epub 2016 Sep 20. | |
| 20190103 | Background | Eubanks JD. Antifibrinolytics in major orthopaedic surgery. J Am Acad Orthop Surg. 2010 Mar;18(3):132-8. |
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One participant was enrolled twice for separate hip fractures, so one of the enrollments was removed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution |
| FG001 | Placebo | 100 cc normal saline Placebo: 100 cc normal saline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participant enrolled twice for separate hip fractures - one enrollment removed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution |
| BG001 | 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 | Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells. | Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI. | All participants who underwent treatment. | Posted | Count of Participants | Participants | 3 Months |
|
3 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 | Intervention | 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia (worsening of condition -> death) | Endocrine disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderate | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Halle Becker | LancasterGH | 7175441401 | halle.becker@pennmedicine.upenn.edu |
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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 | Jun 17, 2019 | Apr 30, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 7, 2024 | Jun 25, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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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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A prospective, double-blinded, randomized study in the geriatric hip fracture population comparing those who receive intravenous tranexamic acid prior to incision to those who receive a placebo.
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All OR pharmacists are un-blinded to subject randomization.
| Placebo | Other | 100 cc normal saline |
|
| Hospital Readmission |
Determine differences between the groups in 30 day readmission rates. |
| 30 Days |
| Mortality Rate | Death within 90 days post hip surgery | 90 Days |
| Length of Stay | Length of stay immediately post study intervention/surgery for hip fracture | From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months. |
| 25378512 | Background | Ponnusamy KE, Kim TJ, Khanuja HS. Perioperative blood transfusions in orthopaedic surgery. J Bone Joint Surg Am. 2014 Nov 5;96(21):1836-44. doi: 10.2106/JBJS.N.00128. |
| 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. |
| 8874456 | Background | Carson JL, Duff A, Poses RM, Berlin JA, Spence RK, Trout R, Noveck H, Strom BL. Effect of anaemia and cardiovascular disease on surgical mortality and morbidity. Lancet. 1996 Oct 19;348(9034):1055-60. doi: 10.1016/S0140-6736(96)04330-9. |
| 30007789 | Background | Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Shores P, Mullen K, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. The Efficacy of Tranexamic Acid in Total Hip Arthroplasty: A Network Meta-analysis. J Arthroplasty. 2018 Oct;33(10):3083-3089.e4. doi: 10.1016/j.arth.2018.06.023. Epub 2018 Jun 27. |
| 29699826 | Background | Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Shores P, Mullen K, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. The Safety of Tranexamic Acid in Total Joint Arthroplasty: A Direct Meta-Analysis. J Arthroplasty. 2018 Oct;33(10):3070-3082.e1. doi: 10.1016/j.arth.2018.03.031. Epub 2018 Mar 22. |
| 25889413 | Background | Carling MS, Jeppsson A, Eriksson BI, Brisby H. Transfusions and blood loss in total hip and knee arthroplasty: a prospective observational study. J Orthop Surg Res. 2015 Mar 28;10:48. doi: 10.1186/s13018-015-0188-6. |
| 24196467 | Background | Alshryda S, Mason J, Sarda P, Nargol A, Cooke N, Ahmad H, Tang S, Logishetty R, Vaghela M, McPartlin L, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total hip replacement: a randomized controlled trial (TRANX-H). J Bone Joint Surg Am. 2013 Nov 6;95(21):1969-74. doi: 10.2106/JBJS.L.00908. |
| 24196466 | Background | Alshryda S, Mason J, Vaghela M, Sarda P, Nargol A, Maheswaran S, Tulloch C, Anand S, Logishetty R, Stothart B, Hungin AP. Topical (intra-articular) tranexamic acid reduces blood loss and transfusion rates following total knee replacement: a randomized controlled trial (TRANX-K). J Bone Joint Surg Am. 2013 Nov 6;95(21):1961-8. doi: 10.2106/JBJS.L.00907. |
| 10919295 | Background | Benoni G, Lethagen S, Nilsson P, Fredin H. Tranexamic acid, given at the end of the operation, does not reduce postoperative blood loss in hip arthroplasty. Acta Orthop Scand. 2000 Jun;71(3):250-4. doi: 10.1080/000164700317411834. |
| 19483232 | Background | Rajesparan K, Biant LC, Ahmad M, Field RE. The effect of an intravenous bolus of tranexamic acid on blood loss in total hip replacement. J Bone Joint Surg Br. 2009 Jun;91(6):776-83. doi: 10.1302/0301-620X.91B6.22393. |
| 26703193 | Background | North WT, Mehran N, Davis JJ, Silverton CD, Weir RM, Laker MW. Topical vs Intravenous Tranexamic Acid in Primary Total Hip Arthroplasty: A Double-Blind, Randomized Controlled Trial. J Arthroplasty. 2016 May;31(5):1022-6. doi: 10.1016/j.arth.2015.11.003. Epub 2015 Nov 10. |
| 28244907 | Background | Kayupov E, Fillingham YA, Okroj K, Plummer DR, Moric M, Gerlinger TL, Della Valle CJ. Oral and Intravenous Tranexamic Acid Are Equivalent at Reducing Blood Loss Following Total Hip Arthroplasty: A Randomized Controlled Trial. J Bone Joint Surg Am. 2017 Mar 1;99(5):373-378. doi: 10.2106/JBJS.16.00188. |
| 22704229 | Background | Imai N, Dohmae Y, Suda K, Miyasaka D, Ito T, Endo N. Tranexamic acid for reduction of blood loss during total hip arthroplasty. J Arthroplasty. 2012 Dec;27(10):1838-43. doi: 10.1016/j.arth.2012.04.024. Epub 2012 Jun 14. |
| 27113948 | Background | Fillingham YA, Kayupov E, Plummer DR, Moric M, Gerlinger TL, Della Valle CJ. The James A. Rand Young Investigator's Award: A Randomized Controlled Trial of Oral and Intravenous Tranexamic Acid in Total Knee Arthroplasty: The Same Efficacy at Lower Cost? J Arthroplasty. 2016 Sep;31(9 Suppl):26-30. doi: 10.1016/j.arth.2016.02.081. Epub 2016 Mar 19. |
| 25471907 | Background | Gomez-Barrena E, Ortega-Andreu M, Padilla-Eguiluz NG, Perez-Chrzanowska H, Figueredo-Zalve R. Topical intra-articular compared with intravenous tranexamic acid to reduce blood loss in primary total knee replacement: a double-blind, randomized, controlled, noninferiority clinical trial. J Bone Joint Surg Am. 2014 Dec 3;96(23):1937-44. doi: 10.2106/JBJS.N.00060. |
| 24997651 | Background | Levine BR, Haughom BD, Belkin MN, Goldstein ZH. Weighted versus uniform dose of tranexamic acid in patients undergoing primary, elective knee arthroplasty: a prospective randomized controlled trial. J Arthroplasty. 2014 Sep;29(9 Suppl):186-8. doi: 10.1016/j.arth.2014.01.038. Epub 2014 May 27. |
| 18929686 | Background | Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30. |
| 41837612 | Derived | Sullivan M, Perea LL, Bradburn E, Guglielmo K, Bresz K, Horst M, Martin B, Heinle C, Tocks G. The Effect of Preoperative Tranexamic Acid on Blood Transfusions in Geriatric Hip Fracture Surgery: A Randomized Controlled Trial. J Orthop Trauma. 2026 Jul 1;40(7):341-347. doi: 10.1097/BOT.0000000000003172. |
| Withdrawal by Subject |
|
| Participant enrolled twice for separate hip fractures - one enrollment removed. |
|
100 cc normal saline
Placebo: 100 cc normal saline
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
100 cc normal saline
Placebo: 100 cc normal saline
Includes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects
|
|
|
| Secondary | Complication Rate | Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery. | Posted | Count of Participants | Participants | 3 Months |
|
|
|
|
| Secondary | Hospital Readmission | Determine differences between the groups in 30 day readmission rates. | Posted | Count of Participants | Participants | 30 Days |
|
|
|
|
| Secondary | Mortality Rate | Death within 90 days post hip surgery | Posted | Count of Participants | Participants | 90 Days |
|
|
|
|
| Secondary | Length of Stay | Length of stay immediately post study intervention/surgery for hip fracture | Posted | Mean | Standard Deviation | days | From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months. |
|
|
|
|
| 16 |
| 146 |
| 3 |
| 146 |
| 69 |
| 146 |
| EG001 | Placebo | 100 cc normal saline Placebo: 100 cc normal saline | 12 | 137 | 1 | 137 | 57 | 137 |
| Acute infarct in R parietal region (pt released on hospice) | Vascular disorders | Non-systematic Assessment |
|
| Post-operative respiratory failure with hypercarbia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Death | General disorders | Non-systematic Assessment | Pt was demonstrating a general decline. Pt started hospice care and expired due to multiple co-morbidities. |
|
| Mild | General disorders | Non-systematic Assessment |
|
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