Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population

NCT03923959 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: LancasterGH
• Study Type: interventional
• Target: 283
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Fractures

Keywords

Blood; Transfusion; Hip; Fracture; Surgery; Replacement; Trauma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Complication Rate

  3 Months

• Hospital Readmission

  30 Days

• Mortality Rate

  90 Days

• Length of Stay

  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.

Study Arms (2)

Intervention

ACTIVE COMPARATOR

100 cc normal saline with 1g of tranexamic acid in solution

Drug: Tranexamic Acid Injectable Solution

Placebo

PLACEBO COMPARATOR

100 cc normal saline

Other: Placebo

Interventions

Tranexamic Acid Injectable Solution DRUG

100 cc normal saline mixed with 1g of tranexamic acid in solution

Also known as: Cyklokapron

Intervention

Placebo OTHER

100 cc normal saline

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Age \> or = to 65 years
• Hip fracture location within the femoral neck, intertrochanteric, and subtrochanteric regions
• Indication for one of the following surgical interventions: hemiarthroplasty, total hip replacement, sliding plate and screw fixation, or intramedullary fixation

You may not qualify if:

• Indication for closed reduction or percutaneous screw
• Allergy to TXA
• Cerebrovascular accident/stroke, active coronary disease/myocardial infarction, or deep vein thrombosis/pulmonary emboli within one (1) month of the fracture
• Presence of hypercoaguable disorder, including cancer (active disease), elevated blood homocysteine levels, antiphospholipid antibody syndrome and inherited protein deficiencies (antithrombin III, factor V Leiden, protein S \& C deficiencies, prothrombin gene mutation)

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Lancaster General Heatlh / Penn Medicine

Lancaster, Pennsylvania, 17602, United States

Location

Related Publications (19)

• 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.

  PMID: 27492116 BACKGROUND

• Eubanks JD. Antifibrinolytics in major orthopaedic surgery. J Am Acad Orthop Surg. 2010 Mar;18(3):132-8.

  PMID: 20190103 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.

  PMID: 25378512 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.

  PMID: 19007970 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.

  PMID: 8874456 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.

  PMID: 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 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.

  PMID: 29699826 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.

  PMID: 25889413 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.

  PMID: 24196467 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.

  PMID: 24196466 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.

  PMID: 10919295 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.

  PMID: 19483232 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.

  PMID: 26703193 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.

  PMID: 28244907 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.

  PMID: 22704229 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.

  PMID: 27113948 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.

  PMID: 25471907 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.

  PMID: 24997651 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.

  PMID: 18929686 BACKGROUND

MeSH Terms

Conditions

Hip Fractures; Fractures, Bone; Wounds and Injuries

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Femoral Fractures; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Halle Becker
• Organization: LancasterGH

halle.becker@pennmedicine.upenn.edu

7175441401

Study Officials

• Gregory Tocks, DO

  Penn Medicine / Lancaster General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All OR pharmacists are un-blinded to subject randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: February 1, 2020
• Primary Completion: December 9, 2022
• Study Completion: December 9, 2022
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)