Comparison of tranexamic acid and prednisolone in the treatment of traumatic hyphema. A randomized clinical trial.

OBJECTIVE: Oral antifibrinolytics, oral steroids, and no oral treatment are the preferred medical treatments for traumatic hyphema. Antifibrinolytics and steroids have decreased the chance of rebleeding in some studies but failed to alter the clinical course in others. Rate of secondary hemorrhage seems variable among different geographic and ethnic groups of patients. Comparison of the treatments in each population is necessary to document the most effective method of preventing recurrent hemorrhage.
DESIGN: Randomized, placebo-controlled, clinical trial. PARTICIPANTS: Two hundred thirty-eight patients in whom hyphema developed after a blunt trauma entered the study. INTERVENTION: Eighty patients received 75 mg/kg per day oral tranexamic acid (TA) divided into 3 doses, 80 patients received a placebo with the same number of tablets and frequency as those of the TA group, and 78 patients received 0.75 mg/kg per day oral prednisolone divided into 2 doses. MAIN OUTCOME MEASURE: Secondary hemorrhage during the hospital course was measured.
RESULTS: Secondary hemorrhage occurred in 8 patients (10%) of the TA group, 14 patients (18%) of the prednisolone group, and 21 patients (26%) of the placebo group. The difference between the incidence of rebleeding between TA and placebo groups was statistically significant (P = 0.008). Patients receiving a placebo had a greater chance of secondary bleeding than did patients receiving TA (odds ratios = 3.2; 95% confidence interval = 1.3, 7.5). The incidences of rebleeding were not significantly different in placebo versus prednisolone groups (P = 0.21) and TA versus prednisolone groups (P = 0.15).
CONCLUSION: In a population with a high rate of secondary bleeding, TA is more effective than oral prednisolone or no oral treatment in preventing rebleeding among patients with traumatic hyphema.

RCT Entities:   Population Interventions Outcomes