Volume 28, Issue 2 pp. 525-531
Original Article

Head down tilt 15° in experimental intracerebral hemorrhage: a randomized noninferiority safety trial

S. Beretta

Corresponding Author

S. Beretta

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

Department of Neuroscience, ASST Monza, San Gerardo Hospital, Monza, Italy

Correspondence: S. Beretta, Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano Bicocca, Via Cadore 48, 20900 Monza, Italy (tel.: +390264488128; fax +390264488102. e-mail: [email protected]).

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A. Versace

A. Versace

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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B. Martini

B. Martini

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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M. Viganò

M. Viganò

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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S. Diamanti

S. Diamanti

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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C. Pini

C. Pini

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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G. Paternò

G. Paternò

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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D. Carone

D. Carone

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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J. Mariani

J. Mariani

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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L. Monza

L. Monza

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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M. Riva

M. Riva

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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G. Padovano

G. Padovano

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

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E. Rossi

E. Rossi

Center of Biostatistics, Department of Medicine and Surgery, University of Milano Bicocca, Monza, Italy

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G. Citerio

G. Citerio

Department of Intensive Care, ASST Monza, San Gerardo Hospital, Monza, Italy

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G. Castoldi

G. Castoldi

Department of Medicine and Surgery, University of Milano Bicocca, Monza, Italy

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F. Padelli

F. Padelli

Neuroradiology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy

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I. Giachetti

I. Giachetti

Neuroradiology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy

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D. Aquino

D. Aquino

Neuroradiology Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy

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C. Giussani

C. Giussani

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

Department of Neuroscience, ASST Monza, San Gerardo Hospital, Monza, Italy

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E. P. Sganzerla

E. P. Sganzerla

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

Department of Neuroscience, ASST Monza, San Gerardo Hospital, Monza, Italy

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C. Ferrarese

C. Ferrarese

Laboratory of Experimental Stroke Research, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy

Department of Neuroscience, ASST Monza, San Gerardo Hospital, Monza, Italy

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First published: 28 September 2020
Citations: 6

See editorial by G. Tsivgoulis and A. H. Katsanos on page 363

Abstract

Background and purpose

Head down tilt 15° (HDT15°), applied before recanalization, increases collateral flow and improves outcome in experimental ischemic stroke. For its simplicity and low cost, HDT15° holds considerable potential to be developed as an emergency treatment of acute stroke in the prehospital setting, where hemorrhagic stroke is the major mimic of ischemic stroke. In this study, we assessed safety of HDT15° in the acute phase of experimental intracerebral hemorrhage.

Methods

Intracerebral hemorrhage was produced by stereotaxic injection of collagenase in Wistar rats. A randomized noninferiority trial design was used to assign rats to HDT15° or flat position (n = 64). HDT15° was applied for 1 h during the time window of hematoma expansion. The primary outcome was hematoma volume at 24 h. Secondary outcomes were mass effect, mortality, and functional deficit in the main study and acute changes of intracranial pressure, hematoma growth, and cardiorespiratory parameters in separate sets of randomized animals (n = 32).

Results

HDT15° achieved the specified criteria of noninferiority for hematoma volume at 24 h. Mass effect, mortality, and functional deficit at 24 h showed no difference in the two groups. HDT15° induced a mild increase in intracranial pressure with respect to the pretreatment values (+2.91 ± 1.76 mmHg). HDT15° had a neutral effect on MRI-based analysis of hematoma growth and cardiorespiratory parameters.

Conclusions

Application of HDT15° in the hyperacute phase of experimental intracerebral hemorrhage does not worsen early outcome. Further research is needed to implement HDT15° as an emergency collateral therapeutic for acute stroke.

Disclosure of conflicts of interest

The authors declare no financial or other conflicts of interest.

Data availability statement

The data that support the findings of this study are available from the corresponding author upon request.

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