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Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign (PREDICT): a prospective observational study
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Summary

Background

In patients with intracerebral haemorrhage (ICH), early haemorrhage expansion affects clinical outcome. Haemostatic treatment reduces haematoma expansion, but fails to improve clinical outcomes in many patients. Proper selection of patients at high risk for haematoma expansion seems crucial to improve outcomes. In this study, we aimed to prospectively validate the CT-angiography (CTA) spot sign for prediction of haematoma expansion.

Methods

PREDICT (predicting haematoma growth and outcome in intracerebral haemorrhage using contrast bolus CT) was a multicentre prospective observational cohort study. We recruited patients aged 18 years or older, with ICH smaller than 100 mL, and presenting at less than 6 h from symptom onset. Using two independent core laboratories, one neuroradiologist determined CTA spot-sign status, whereas another neurologist masked for clinical outcomes and imaging measured haematoma volumes by computerised planimetry. The primary outcome was haematoma expansion defined as absolute growth greater than 6 mL or a relative growth of more than 33%from initial CT to follow-up CT. We reported data using standard descriptive statistics stratified by the CTA spot sign. Mortality was assessed with Kaplan-Meier survival analysis.

Findings

We enrolled 268 patients. Median time from symptom onset to baseline CT was 135 min (range 22-470), and time from onset to CTA was 159 min (32-475). 81 (30%) patients were spot-sign positive. The primary analysis included 228 patients, who had a follow-up CT before surgery or death. Median baseline ICH volume was 19路9 mL (1路5-80路9) in spot-sign-positive patients versus 10路0 mL (0路1-102路7) in spot-sign negative patients (p<0路001). Median ICH expansion was 8路6 mL (鈭?路3 to 121路7) for spot-sign positive patients and 0路4 mL (鈭?1路7 to 98路3) for spot-negative patients (p<0路001). In those with haematoma expansion, the positive predictive value for the spot sign was 73%; the negative predictive value was 84%, sensitivity was 63%, and specificity was 90%. Median 3-month modified Rankin Scale (mRS) was 5 in CTA spot-sign-positive patients, and 3 in spot-sign-negative patients (p<0路001). Mortality at 3 months was 43路4%(23 of 53) in CTA spot-sign positive versus 19路6%(31 of 158) in CTA spot-sign-negative patients (HR 2路4, 95%CI 1路4-4路0, p=0路002).

Interpretation

These findings confirm previous single-centre studies showing that the CTA spot sign is a predictor of haematoma expansion. The spot sign is recommended as an entry criterion for future trials of haemostatic therapy in patients with acute ICH.

Funding

Canadian Stroke Consortium and NovoNordisk Canada.

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