An open label randomized trial to assess the efficacy of tranexamic acid in reducing post-operative recurrence of chronic subdural haemorrhage

Abstract

Chronic subdural haemorrhage (CSDH) is a common neurosurgical entity with complex pathophysiological pathways. The generally favourable surgical outcome may be affected by its associated risks including recurrence rates. We performed a prospective randomized multi-center clinical trial comparing the addition of tranexamic acid (TXA) to standard neurosurgical procedures for patients with symptomatic CSDH. The primary endpoint was CSDH requiring repeat surgery within 6-month post-operatively. Secondary endpoints were comparison of post-operative volumes between the treatment arms and safety evaluation of the dosing regime. 90 patients were analyzed with 49 patients in the observation arm and 41 patients in the TXA arm. The observation arm had five (10.2%) recurrences compared to two (4.8%, p = 0.221) in the TXA arm. Patients in the TXA arm demonstrated a greater reduction of their CSDH volume at 6 weeks follow up (36.6%) compared to the observation arm (23.3%, p = 0.6648). There were no reportable serious adverse events recorded in the observation arm, compared to 4 (9.8%) patients in the TXA arm. The addition of TXA treatment to standard surgical drainage of CSH did not significantly reduce symptomatic post-operative recurrence. Patients in the TXA arm had a delay in the CSDH recurrence with a comparative reduction of residual hematoma volume at the 6-week follow up although the effect was unsustained. Larger randomized trials with dose adjustments should be considered to investigate subgroups of patients that may benefit from this medical adjunct.

Keywords: Chronic subdural haemorrhage; Post-operative recurrence; Randomized trial; Tranexamic acid.