Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2023-04-12
2024-11-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm
Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery
Tranexamic acid (TXA)
1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery
Control Group
The control group will have saline administered 10 minutes prior to surgery.
Saline
control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.
Interventions
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Tranexamic acid (TXA)
1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery
Saline
control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation.
3. Must be able to read and understand English and consent for themselves.
Exclusion Criteria
2. Acquired disturbances of color vision.
3. History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA.
4. Pregnant or breastfeeding.
5. Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement.
6. Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men)
7. Refusal of blood products
8. Subarachnoid hemorrhage
9. Disseminated intravascular coagulation
18 Years
100 Years
ALL
No
Sponsors
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Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
OTHER
Responsible Party
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Peter Tang
Associate Professor of Orthopaedic Surgery
Principal Investigators
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Peter Tang, MD
Role: PRINCIPAL_INVESTIGATOR
Allegheny Health Network Allegheny General Hospital
Locations
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Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Countries
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References
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Arnould G, Hartemann P, Tridon P, Weber M, Floquet J, Cagniart MJ. [Balo's concentric sclerosis with dementia]. Rev Neurol (Paris). 1970 Mar;122(3):203-8. No abstract available. French.
Hughes JM, Seale JP, Temple DM. Effect of fenoterol on immunological release of leukotrienes and histamine from human lung in vitro: selective antagonism by beta-adrenoceptor antagonists. Eur J Pharmacol. 1983 Nov 25;95(3-4):239-45. doi: 10.1016/0014-2999(83)90640-4.
Cheriyan T, Maier SP 2nd, Bianco K, Slobodyanyuk K, Rattenni RN, Lafage V, Schwab FJ, Lonner BS, Errico TJ. Efficacy of tranexamic acid on surgical bleeding in spine surgery: a meta-analysis. Spine J. 2015 Apr 1;15(4):752-61. doi: 10.1016/j.spinee.2015.01.013. Epub 2015 Jan 21.
Yu X, Wang J, Wang X, Xie L, Chen C, Zheng W. The efficacy and safety of tranexamic acid in the treatment of intertrochanteric fracture: an updated meta-analysis of 11 randomized controlled trials. J Thromb Thrombolysis. 2020 Aug;50(2):243-257. doi: 10.1007/s11239-019-02034-1.
Spitler CA, Row ER, Gardner WE 2nd, Swafford RE, Hankins MJ, Nowotarski PJ, Kiner DW. Tranexamic Acid Use in Open Reduction and Internal Fixation of Fractures of the Pelvis, Acetabulum, and Proximal Femur: A Randomized Controlled Trial. J Orthop Trauma. 2019 Aug;33(8):371-376. doi: 10.1097/BOT.0000000000001480.
Baskaran D, Rahman S, Salmasi Y, Froghi S, Berber O, George M. Effect of tranexamic acid use on blood loss and thromboembolic risk in hip fracture surgery: systematic review and meta-analysis. Hip Int. 2018 Jan;28(1):3-10. doi: 10.5301/hipint.5000556.
Gausden EB, Qudsi R, Boone MD, O'Gara B, Ruzbarsky JJ, Lorich DG. Tranexamic Acid in Orthopaedic Trauma Surgery: A Meta-Analysis. J Orthop Trauma. 2017 Oct;31(10):513-519. doi: 10.1097/BOT.0000000000000913.
Franchini M, Mengoli C, Marietta M, Marano G, Vaglio S, Pupella S, Mannucci PM, Liumbruno GM. Safety of intravenous tranexamic acid in patients undergoing majororthopaedic surgery: a meta-analysis of randomised controlled trials. Blood Transfus. 2018 Jan;16(1):36-43. doi: 10.2450//2017.0219-17.
Hooda B, Chouhan RS, Rath GP, Bithal PK, Suri A, Lamsal R. Effect of tranexamic acid on intraoperative blood loss and transfusion requirements in patients undergoing excision of intracranial meningioma. J Clin Neurosci. 2017 Jul;41:132-138. doi: 10.1016/j.jocn.2017.02.053. Epub 2017 Mar 7.
Franchini M, Mengoli C, Cruciani M, Bergamini V, Presti F, Marano G, Pupella S, Vaglio S, Masiello F, Veropalumbo E, Piccinini V, Pati I, Liumbruno GM. Safety and efficacy of tranexamic acid for prevention of obstetric haemorrhage: an updated systematic review and meta-analysis. Blood Transfus. 2018 Jul;16(4):329-337. doi: 10.2450/2018.0026-18. Epub 2018 Apr 3.
Ali Algadiem E, Aleisa AA, Alsubaie HI, Buhlaiqah NR, Algadeeb JB, Alsneini HA. Blood Loss Estimation Using Gauze Visual Analogue. Trauma Mon. 2016 May 3;21(2):e34131. doi: 10.5812/traumamon.34131. eCollection 2016 May.
Goobie SM, Zurakowski D, Glotzbecker MP, McCann ME, Hedequist D, Brustowicz RM, Sethna NF, Karlin LI, Emans JB, Hresko MT. Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2018 Dec 5;100(23):2024-2032. doi: 10.2106/JBJS.18.00314.
Cuff DJ, Simon P, Gorman RA 2nd. Randomized prospective evaluation of the use of tranexamic acid and effects on blood loss for proximal humeral fracture surgery. J Shoulder Elbow Surg. 2020 Aug;29(8):1627-1632. doi: 10.1016/j.jse.2020.04.016. Epub 2020 Jun 9.
Yang YY, Qin H, Zheng X, Hu B, Zhang M, Ma T. Administration of Tranexamic Acid in Proximal Humeral Fractures. Indian J Orthop. 2020 May 11;54(Suppl 2):277-282. doi: 10.1007/s43465-020-00128-0. eCollection 2020 Dec.
Other Identifiers
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2021-153
Identifier Type: -
Identifier Source: org_study_id