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.
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).
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.
Canadian Stroke Consortium and NovoNordisk Canada.