Data from: Pooled analysis suggests benefit of catheter-based hematoma removal for intracerebral hemorrhage

Objective: To develop models of outcome for intracerebral hemorrhage (ICH)
to identify promising and futile interventions based on their early phase
results without need for correction for baseline imbalances. Methods: We
developed a pooled outcome model from the control arms of randomized
control trials and tested different interventions against the model at
comparable baseline conditions. Eligible clinical trials and large case
series were identified from multiple library databases. Models based on
baseline factors reported in the control arms were tested for the ability
to predict functional outcome (modified Rankin Scale score) and mortality.
Interventions were grouped into blood pressure control,
fibrinolytic-assisted hematoma evacuation, hemostatic medications, and
neuroprotective agents. Statistical intervals around the model were
generated at the p = 0.1 level to screen how each trial’s outcome compared
to expected outcome. Results: Fourteen control arms with 3,386 patients
were used to develop 7 alternate models for functional outcome. The model
incorporating baseline NIH Stroke Scale, age, and hematoma volume yielded
the best fit (adjusted R2 = 0.89). All early phase treatments that
eventually resulted in negative late phase trials were identified as
negative by this method. Early phase fibrinolytic-assisted hematoma
evacuation studies showed the most promise trending toward improved
functional outcome with no suggestion of an increase in mortality,
supporting its further study. Conclusions: We successfully developed an
outcome model for ICH that identified interventions destined to be
negative while identifying a promising one. Such an approach may assist in
prioritizing resources prior to multicenter trial.