Clinical trial NCT05802238: Efficacy of Tranexamic Acid (TXA) in Humerus ORIF
Official title: Efficacy of Tranexamic Acid (TXA) in Humerus ORIF
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Fracture Humerus
Keywords: Open Reduction Internal Fixation
Blood loss
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center randomized controlled trial, parallel two-arm design allocation 1:1 exposed-control design
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Blood loss
timeFrame: Intraoperatively
Secondary outcomes:
measure: Operative Time
timeFrame: From the start of surgical procedure through the completion of the surgical procedure
measure: Duration of follow-up
timeFrame: Through study completion, an average of one year.
measure: Complications (DVT, PE, stroke)
timeFrame: through study completion, an average of one year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny Health Network Allegheny General Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network Allegheny General Hospital
name: Peter Tang, MD
role: PRINCIPAL_INVESTIGATOR
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