title: Hemicraniectomy and durotomy upon deterioration from infarction-related swelling trial: randomized pilot clinical trial.
abstract: OBJECTIVE
  Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial (HeADDFIRST) was a randomized pilot study to obtain information necessary to design a Phase III trial to evaluate the benefit of surgical decompression for brain swelling from large supratentorial cerebral hemispheric infarction.
  
  
  METHODS
  All patients with stroke were screened for eligibility (age 18-75 years, National Institutes of Health Stroke Scale≥18 with Item 1a<2 [responsive to minor stimulation], and CT demonstrating unilateral, complete middle cerebral artery territory infarction by specific imaging criteria). All enrolled patients were treated using a standardized medical treatment protocol. Those with both≥4 mm of pineal shift and deterioration in level of arousal or ≥7.5 mm of anteroseptal shift within 96 hours of stroke onset were randomized to continued medical treatment only or medical treatment plus surgery. Death at 21 days was the primary outcome measure.
  
  
  RESULTS
  Among 4909 screened patients, only 66 (1.3%) patients were eligible for HeADDFIRST. Forty patients were enrolled, and 26 patients developed the requisite brain swelling for randomization. All who failed to meet randomization criteria were alive at 21 days. Mortality at 21 and 180 days was 40% (4/10) in the medical treatment only and 21% (3/14) and 36% (5/14) in the medical treatment plus surgery arms, respectively.
  
  
  CONCLUSIONS
  HeADDFIRST randomization criteria effectively distinguished low from high risk of death from large supratentorial cerebral hemispheric infarction. Lower mortality in the medical treatment only group than in other published trials suggests a possible benefit to standardizing medical management. These results can inform the interpretation of recently completed European trials concerning patient selection and medical management.
  
  
  BACKGROUND
  This trial was not registered because enrollment began before July 1, 2005.
authors.affiliation: From the Departments of Neurology (J.I.F., C.K.), Health Studies (L.P.S., K.W., R.A.T.), Statistics (R.A.T.), Anesthesia and Critical Care (R.A.T.), The University of Chicago, IL; Department of Neurosurgery, Mayo Clinic College of Medicine, Rochester, MN (D.C.); and Department of Neurology, Weill Cornell Medical College, New York (A.J.R.).
authors.forename: Jeffrey I
authors.initials: JI
authors.lastname: Frank
authors.forename: L Philip
authors.initials: LP
authors.lastname: Schumm
authors.forename: Kristen
authors.initials: K
authors.lastname: Wroblewski
authors.forename: Douglas
authors.initials: D
authors.lastname: Chyatte
authors.forename: Axel J
authors.initials: AJ
authors.lastname: Rosengart
authors.forename: Christi
authors.initials: C
authors.lastname: Kordeck
authors.forename: Ronald A
authors.initials: RA
authors.lastname: Thisted
mesh_terms: D000328:Adult; D000368:Aged; D001929:Brain Edema / Q000150:complications / Q000401:mortality / Q000601:surgery*; D002544:Cerebral Infarction / Q000150:complications / Q000401:mortality / Q000601:surgery*; D002985:Clinical Protocols; D003422:Critical Care; D003627:Data Interpretation, Statistical; D056424:Decompressive Craniectomy / Q000379:methods*; D004388:Dura Mater / Q000601:surgery*; D005260:Female; D006801:Humans; D020244:Infarction, Middle Cerebral Artery / Q000150:complications / Q000601:surgery; D007427:Intracranial Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D018579:Patient Selection; D010865:Pilot Projects; D018401:Sample Size; D020521:Stroke / Q000209:etiology / Q000601:surgery / Q000628:therapy; D016896:Treatment Outcome
keywords: brain edema; craniectomy; stroke