Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Conditions
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Fracture Humerus

Intervention / Treatment
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* Drug: Tranexamic acid (TXA)
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 18-100 years Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation. Must be able to read and understand English and consent for themselves. Exclusion Criteria: Allergy to TXA. Acquired disturbances of color vision. History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA. Pregnant or breastfeeding. Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement. Renal impairment (creatinine above 1.2 in women, creatinine above 1.4 in men) Refusal of blood products Subarachnoid hemorrhage Disseminated intravascular coagulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery | Drug: Tranexamic acid (TXA)<br>* 1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery<br>|
| Placebo Comparator: Control Group<br>The control group will have saline administered 10 minutes prior to surgery. | Other: Saline<br>* control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Amount of time of operative procedure | From the start of surgical procedure through the completion of the surgical procedure | 
| Duration of follow-up | Through study completion, an average of one year. | Through study completion, an average of one year. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open Reduction Internal Fixation, Blood loss