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Abstract
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.
Glossary
- AIC=
- Akaike Information Criterion;
- ATACH=
- Antihypertensive Treatment of Acute Cerebral Hemorrhage;
- BP=
- blood pressure;
- CI=
- confidence interval;
- ENOS=
- Efficacy of Nitric Oxide in Stroke;
- FAST=
- Recombinant Factor VIIa in Acute Intracerebral Haemorrhage;
- GCS=
- Glasgow Coma Scale;
- ICH=
- intracerebral hemorrhage;
- INTERACT=
- Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial;
- IVH=
- intraventricular hemorrhage;
- MISTIE=
- Minimally Invasive Surgery plus rt-PA for Intracerebral Hemorrhage Evacuation;
- mRS=
- modified Rankin Scale;
- NIHSS=
- NIH Stroke Scale;
- PATCH=
- Platelet Transfusion versus Standard Care After Acute Stroke due to Spontaneous Cerebral Haemorrhage Associated With Antiplatelet Therapy;
- RCT=
- randomized clinical trial;
- rFVIIa=
- recombinant factor VIIa;
- SSS=
- Scandinavian Stroke Scale
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Editorial, page 689
CME Course: NPub.org/cmelist
- Received March 19, 2018.
- Accepted in final form December 6, 2018.
- © 2019 American Academy of Neurology
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