Fracture Humerus
Conditions
Keywords
Open Reduction Internal Fixation, Blood loss
Brief 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.
Detailed 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).
Interventions
DRUGTranexamic acid (TXA)
1 gram of TXA in 10mg single-dose ampule (100mg/mL) administered 10 minutes prior to surgery
OTHERSaline
control group will receive 10 mL of normal saline infused intravenously at 1 mL/min.
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | Intraoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | From the start of surgical procedure through the completion of the surgical procedure | Amount of time of operative 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) | through study completion, an average of one year | Presence or absence of the monitored complications (DVT, PE, stroke) will be recorded as a categorical data value. |
Countries
United States
Outcome results
None listed