WP4 – Dutch Intracerebral hemorrhage Surgery Trial (DIST); Minimally invasive endoscopy-guidedsurgery for intracerebral hemorrhage

WP leaders

Karin Klijn (RUMC) & Ruben Dammers (EMC)

Website

https://dutch-ich.nl/

The workpackage

Intracerebral hemorrhage (ICH) accounts for 15% of all strokes. Thirty-day case fatality is 40% and of those surviving, few gain independence. Except for stroke unit care and early blood pressure lowering, there is no treatment of proven benefit. Surgical treatment has so far not been proven effective. A systematic review of randomized trials has found an overall benefit of surgical treatment of supratentorial ICH for both survival and functional outcome, especially when performed early after symptom onset. Besides reducing mass effect from the hematoma, surgery might also lessen secondary brain injury and edema. In the recent Dutch ICH Surgery pilot study we have shown that minimally invasive endoscopy-guided surgical treatment performed within 8 hours of symptom onset in patients with supratentorial ICH is feasible, safe and can effectively reduce ICH volume. For the Dutch ICH Surgery Trial (DIST) we hypothesize that early minimally invasive endoscopy-guided surgery improves functional outcome in patients with supratentorial ICH compared to best medical treatment alone. Cerebellar ICH accounts for 15% of all ICH and is associated with hydrocephalus, brainstem compression and herniation. There are no randomized trials in patients with cerebellar ICH. We aim to assess whether early minimally invasive endoscopyguided surgical cerebellar hematoma removal is feasible, safe and can result in hematoma volume reduction in a phase-2 pilot study (CONVINCE).

Objectives

Primary objective
To assess whether minimally invasive endoscopy-guided surgery for treatment of supratentorial spontaneous, non-traumatic ICH performed within 8 hours of symptom onset, improves functional outcome at 6 months.

Secondary objectives

  1. To determine whether patients treated with minimally invasive surgery develop less perihematomal edema on non-contrast CT at day 6 (±1 day) than controls, and whether CT perfusion (CTP) permeability surface-area product (PS) around the ICH at baseline modifies this effect (DIST-INFLAME).
  2. To compare immune profiles over time in venous blood between surgically treated patients and controls (DIST-INFLAME).
  3. To assess the cost-effectiveness and budget-impact of minimally invasive endoscopy-guided surgery for the treatment of supratentorial ICH performed within 8 hours of symptom onset (DIST-ABC).

Tertiary objective
To design a pilot RCT to study whether minimally invasive endoscopy-guided surgery for treatment of cerebellar spontaneous ICH performed within 8 hours of symptom onset, is feasible, safe and can effectively reduce hematoma volume.