WithdrawnPhase 2

Efficacy of Tranexamic Acid (TXA) in Humerus ORIF

Stopped: Lack of staffing

United States0Started 2023-04-12

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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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

What they're measuring

Blood loss

Timeframe: Intraoperatively

Trial details

NCT IDNCT05802238

SponsorAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-25

View on ClinicalTrials.gov More Fracture Humerus trials