Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial

Author:

Frank Jeffrey I.1,Schumm L. Philip1,Wroblewski Kristen1,Chyatte Douglas1,Rosengart Axel J.1,Kordeck Christi1,Thisted Ronald A.1,Bernardini Gary2,Andrefsky John,Krieger Derk3,Elkind Mitchell4,Coplin William5,Graffagnino Carmelo6,Biller Jose7,Wang David8,Cruz-Flores Salvador9,Brock David10,Demchuk Andrew11,Verro Piero12,Frank Jeffrey13,Woo Daniel14,Suarez Jose15,Pettigrew Creed16,LaMonte Marian17,

Affiliation:

1. 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.).

2. Albany Medical College

3. The Cleveland Clinic Foundation

4. Columbia-Presbyterian Hospital

5. Detroit Receiving Hospital

6. Duke University Medical Center

7. Indiana University Medical Center

8. OSF Saint Francis Medical Center

9. St. Louis University Health Sciences Center

10. Thomas Jefferson University

11. University of Calgary

12. University of California Davis

13. University of Chicago

14. University of Cincinnati

15. University Hospitals of Cleveland

16. University of Kentucky

17. University of Maryland

Abstract

Background and Purpose— 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. Clinical Trial Registration— This trial was not registered because enrollment began before July 1, 2005.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialised Nursing,Cardiology and Cardiovascular Medicine,Clinical Neurology

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