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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery
control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.
Allegheny Health Network Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
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.
Time frame: Intraoperatively
Operative Time
Amount of time of operative procedure
Time frame: 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.
Time frame: 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.
Time frame: through study completion, an average of one year
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