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Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial: Randomized Pilot Clinical Trial

Stroke (1970), 2014-03, Vol.45 (3), p.781-787 [Peer Reviewed Journal]

2015 INIST-CNRS ;ISSN: 0039-2499 ;EISSN: 1524-4628 ;DOI: 10.1161/STROKEAHA.113.003200 ;PMID: 24425122 ;CODEN: SJCCA7

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Title:
Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial: Randomized Pilot Clinical Trial
Author: FRANK, Jeffrey I ; SCHUMM, L. Philip ; WROBLEWSKI, Kristen ; CHYATTE, Douglas ; ROSENGART, Axel J ; KORDECK, Christi ; THISTED, Ronald A
Subjects: Adult ; Aged ; Biological and medical sciences ; Brain Edema - complications ; Brain Edema - mortality ; Brain Edema - surgery ; Cerebral Infarction - complications ; Cerebral Infarction - mortality ; Cerebral Infarction - surgery ; Clinical Protocols ; Critical Care ; Data Interpretation, Statistical ; Decompressive Craniectomy - methods ; Dura Mater - surgery ; Female ; Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy ; Humans ; Infarction, Middle Cerebral Artery - complications ; Infarction, Middle Cerebral Artery - surgery ; Intracranial Pressure - physiology ; Male ; Medical sciences ; Middle Aged ; Monitoring, Physiologic ; Nervous system (semeiology, syndromes) ; Neurology ; Neuropharmacology ; Patient Selection ; Pharmacology. Drug treatments ; Pilot Projects ; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer ; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease) ; Psychology. Psychoanalysis. Psychiatry ; Psychopharmacology ; Sample Size ; Stroke - etiology ; Stroke - surgery ; Stroke - therapy ; Treatment Outcome ; Vascular diseases and vascular malformations of the nervous system
Is Part Of: Stroke (1970), 2014-03, Vol.45 (3), p.781-787
Description: 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. 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. 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. 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. This trial was not registered because enrollment began before July 1, 2005.
Publisher: Hagerstown, MD: Lippincott Williams & Wilkins
Language: English
Identifier: ISSN: 0039-2499
EISSN: 1524-4628
DOI: 10.1161/STROKEAHA.113.003200
PMID: 24425122
CODEN: SJCCA7
Source: MEDLINE
Alma/SFX Local Collection

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Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial: Randomized Pilot Clinical Trial

2015 INIST-CNRS ;ISSN: 0039-2499 ;EISSN: 1524-4628 ;DOI: 10.1161/STROKEAHA.113.003200 ;PMID: 24425122 ;CODEN: SJCCA7

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