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Hemicraniectomy and durotomy upon deterioration from infarction-related swelling trial: randomized pilot clinical trial.

Publication ,  Journal Article
Frank, JI; Schumm, LP; Wroblewski, K; Chyatte, D; Rosengart, AJ; Kordeck, C; Thisted, RA; HeADDFIRST Trialists,
Published in: Stroke
March 2014

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.

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Published In

Stroke

DOI

EISSN

1524-4628

Publication Date

March 2014

Volume

45

Issue

3

Start / End Page

781 / 787

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Sample Size
  • Pilot Projects
  • Patient Selection
  • Neurology & Neurosurgery
  • Monitoring, Physiologic
  • Middle Aged
  • Male
  • Intracranial Pressure
 

Citation

APA
Chicago
ICMJE
MLA
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Frank, J. I., Schumm, L. P., Wroblewski, K., Chyatte, D., Rosengart, A. J., Kordeck, C., … HeADDFIRST Trialists, . (2014). Hemicraniectomy and durotomy upon deterioration from infarction-related swelling trial: randomized pilot clinical trial. Stroke, 45(3), 781–787. https://doi.org/10.1161/STROKEAHA.113.003200
Frank, Jeffrey I., L Philip Schumm, Kristen Wroblewski, Douglas Chyatte, Axel J. Rosengart, Christi Kordeck, Ronald A. Thisted, and Ronald A. HeADDFIRST Trialists. “Hemicraniectomy and durotomy upon deterioration from infarction-related swelling trial: randomized pilot clinical trial.Stroke 45, no. 3 (March 2014): 781–87. https://doi.org/10.1161/STROKEAHA.113.003200.
Frank JI, Schumm LP, Wroblewski K, Chyatte D, Rosengart AJ, Kordeck C, et al. Hemicraniectomy and durotomy upon deterioration from infarction-related swelling trial: randomized pilot clinical trial. Stroke. 2014 Mar;45(3):781–7.
Frank, Jeffrey I., et al. “Hemicraniectomy and durotomy upon deterioration from infarction-related swelling trial: randomized pilot clinical trial.Stroke, vol. 45, no. 3, Mar. 2014, pp. 781–87. Pubmed, doi:10.1161/STROKEAHA.113.003200.
Frank JI, Schumm LP, Wroblewski K, Chyatte D, Rosengart AJ, Kordeck C, Thisted RA, HeADDFIRST Trialists. Hemicraniectomy and durotomy upon deterioration from infarction-related swelling trial: randomized pilot clinical trial. Stroke. 2014 Mar;45(3):781–787.

Published In

Stroke

DOI

EISSN

1524-4628

Publication Date

March 2014

Volume

45

Issue

3

Start / End Page

781 / 787

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Sample Size
  • Pilot Projects
  • Patient Selection
  • Neurology & Neurosurgery
  • Monitoring, Physiologic
  • Middle Aged
  • Male
  • Intracranial Pressure