title: Prediction of haematoma growth and outcome in patients with intracerebral haemorrhage using the CT-angiography spot sign (PREDICT): a prospective observational study.
abstract: 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.
  
  
  RESULTS
  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 19·9 mL (1·5-80·9) in spot-sign-positive patients versus 10·0 mL (0·1-102·7) in spot-sign negative patients (p<0·001). Median ICH expansion was 8·6 mL (-9·3 to 121·7) for spot-sign positive patients and 0·4 mL (-11·7 to 98·3) for spot-negative patients (p<0·001). In those with haematoma expansion, the positive predictive value for the spot sign was61% (95% CI 47–73) for the positive predictive value and 78% (71–84) for the negative predictive value, with 51% (39–63) sensitivity and 85% (78–90) specificity[corrected]. Median 3-month modified Rankin Scale (mRS) was 5 in CTA spot-sign-positive patients, and 3 in spot-sign-negative patients (p<0·001). Mortality at 3 months was 43·4% (23 of 53) in CTA spot-sign positive versus 19·6% (31 of 158) in CTA spot-sign-negative patients (HR 2·4, 95% CI 1·4-4·0, p=0·002).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Canadian Stroke Consortium and NovoNordisk Canada.
authors.affiliation: Calgary Stroke Program, Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada. ademchuk@ucalgary.ca
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Demchuk
authors.forename: Dar
authors.initials: D
authors.lastname: Dowlatshahi
authors.forename: David
authors.initials: D
authors.lastname: Rodriguez-Luna
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Molina
authors.forename: Yolanda Silva
authors.initials: YS
authors.lastname: Blas
authors.forename: Imanuel
authors.initials: I
authors.lastname: Dzialowski
authors.forename: Adam
authors.initials: A
authors.lastname: Kobayashi
authors.forename: Jean-Martin
authors.initials: JM
authors.lastname: Boulanger
authors.forename: Cheemun
authors.initials: C
authors.lastname: Lum
authors.forename: Gord
authors.initials: G
authors.lastname: Gubitz
authors.forename: Vasantha
authors.initials: V
authors.lastname: Padma
authors.forename: Jayanta
authors.initials: J
authors.lastname: Roy
authors.forename: Carlos S
authors.initials: CS
authors.lastname: Kase
authors.forename: Jayme
authors.initials: J
authors.lastname: Kosior
authors.forename: Rohit
authors.initials: R
authors.lastname: Bhatia
authors.forename: Sarah
authors.initials: S
authors.lastname: Tymchuk
authors.forename: Suresh
authors.initials: S
authors.lastname: Subramaniam
authors.forename: David J
authors.initials: DJ
authors.lastname: Gladstone
authors.forename: Michael D
authors.initials: MD
authors.lastname: Hill
authors.forename: Richard I
authors.initials: RI
authors.lastname: Aviv
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002533:Cerebral Angiography / Q000379:methods*; D002536:Cerebral Arteries / Q000000981:diagnostic imaging* / Q000473:pathology; D002543:Cerebral Hemorrhage / Q000150:complications / Q000000981:diagnostic imaging*; D005260:Female; D006406:Hematoma / Q000000981:diagnostic imaging* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D019370:Observation; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D014057:Tomography, X-Ray Computed / Q000379:methods*; D055815:Young Adult