Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Fracture Humerus Clinical Trial

— TXA  

Official title:

Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802238
• Other study ID #: 2021-153
• Status: Recruiting
• Phase: Phase 2
• Start date: April 12, 2023
• Est. completion date: June 30, 2030

Study information

• Verified date: April 2023
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: Pamela M. White, BSN
• Phone: 412-330-6044
• Email: Pamela.White2[@]ahn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if administration of tranexamic acid (TXA), a clotting agent, will decrease blood loss, the need for transfusion, and reduce the likelihood of wound complications such as infection. Investigators will also see if the drug can effectively decrease operative time and length of hospitalization.

Description:

Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design to determine if TXA aids in prevention of blood loss in upper extremity trauma, specifically humerus fractures. Patient population includes male and female adults with no history of thromboses who suffered an isolated humeral injury. Patients will be evaluated at Allegheny General Hospital (AGH) as surgical candidates and allocated to the exposure group (receive TXA) or the control group (saline placebo). Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery. The control group will have saline administered 10 minutes prior to surgery. Patients will be seen in follow up at both 2 weeks and 6 weeks postoperatively, as well as followed through the electronic medical record (EMR).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Males or females age 18-100 years

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:

1. Allergy to TXA.

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

Related Conditions & MeSH terms

• Fracture Humerus
• Humeral Fractures

Intervention

Drug:
• Tranexamic acid (TXA)
1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery

Other:
• Saline
control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.

Locations

Country	Name	City	State
United States	Allegheny Health Network Allegheny General Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Country where clinical trial is conducted

United States, 

References & Publications (14)

Akgul T, Buget M, Salduz A, Edipoglu IS, Ekinci M, Kucukay S, Sen C. Efficacy of preoperative administration of single high dose intravenous tranexamic acid in reducing blood loss in total knee arthroplasty: A prospective clinical study. Acta Orthop Traumatol Turc. 2016 Aug;50(4):429-31. doi: 10.1016/j.aott.2016.06.007. Epub 2016 Jul 16. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sun CX, Zhang L, Mi LD, Du GY, Sun XG, He SW. Efficiency and safety of tranexamic acid in reducing blood loss in total shoulder arthroplasty: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Jun;96(22):e7015. doi: 10.1097/MD.0000000000007015. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss	The estimated total blood loss measured intraoperatively. This will be done by estimating absorbed drainage by surgical gauze and adding this to total volume in suction canister. Total volume of irrigation used will be subtracted from this total to give an estimate of intraoperative blood loss.	Intraoperatively
Secondary	Operative Time	Amount of time of operative procedure	From the start of surgical procedure through the completion of the surgical procedure
Secondary	Duration of follow-up	Through study completion, an average of one year.	Through study completion, an average of one year.
Secondary	Complications (DVT, PE, stroke)	Presence or absence of the monitored complications (DVT, PE, stroke) will be recorded as a categorical data value.	through study completion, an average of one year