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Randomized Controlled Trial
. 2024 May;14(5):e3481.
doi: 10.1002/brb3.3481.

Total intracranial hemorrhage volume measurement summating all compartments best in traumatic and nontraumatic intracranial bleeding

Affiliations
Randomized Controlled Trial

Total intracranial hemorrhage volume measurement summating all compartments best in traumatic and nontraumatic intracranial bleeding

MacKenzie Horn et al. Brain Behav. 2024 May.

Abstract

Background and purpose: The ANNEXA-4 trial measured hemostatic efficacy of andexanet alfa in patients with major bleeding taking factor Xa inhibitors. A proportion of this was traumatic and nontraumatic intracranial bleeding. Different measurements were applied in the trial including volumetrics to assess for intracranial bleeding depending on the compartment involved. We aimed to determine the most reliable way to measure intracranial hemorrhage (ICrH) volume by comparing individual brain compartment and total ICrH volume.

Methods: Thirty patients were randomly selected from the ANNEXA-4 database to assess measurement of ICrH volume by compartment and in total. Total and compartmental hemorrhage volumes were measured by five readers using Quantomo software. Each reader measured baseline hemorrhage volumes twice separated by 1 week. Twenty-eight different ANNEXA-4 subjects were also randomly selected to assess intra-rater reliability of total ICrH volume measurement change at baseline and 12-h follow up, performed by three readers twice to assess hemostatic efficacy categories used in ANNEXA-4.

Results: Compartmental minimal detectable change percentages (MDC%) ranged between 9.72 and 224.13, with the greatest measurement error occurring in patients with a subdural hemorrhage. Total ICrH volume measurements had the lowest MDC%, which ranged between 6.57 and 33.52 depending on the reader.

Conclusion: Measurement of total ICrH volumes is more accurate than volume by compartment with less measurement error. Determination of hemostatic efficacy was consistent across readers, and within the same reader, as well as when compared to consensus read. Volumetric analysis of intracranial hemostatic efficacy is feasible and reliable when using total ICrH volumes.

Keywords: neuroimaging; neurology; neuroscience; stroke.

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Conflict of interest statement

AB, MH, LK, OV, HC, FL, TO, KT, and AAS have no disclosures. SC has received grant support and served as a consultant for Portola, Bristol Myers Squibb, Bayer, and Daiichi Sankyo; has served as a consultant for Javelin; and holds a patent (US 2010/0255000) and pending patent (US 2017/0369862 A1). PL is an employee of AstraZeneca. MC received grants from Bayer AG; and personal fees from Servier Canada, Asahi Kasei, Precision Biologics, Hemostasis Reference Laboratories, Syneos Health, Pfizer Canada, CSL Behring, and Diagnostica Stago. JBW has received personal honoraria and travel support from Bayer, Daiichi Sankyo, Janssen, Sanofi, and Portola/Alexion; and institutional research support from Bayer, Daiichi Sankyo, Janssen, LEO, Pfizer, and Portola/Alexion. AS has received grants and advisory honoraria support from AstraZeneca. AMD has received honoraria from Hoffmann-LaRoche for advisory board consultation; honoraria from Boehringer Ingelheim and Medtronic for CME lectures; is a patent/shareholder in Circle CVI; serves as a consultant, on the adjudication, and steering committees for ANNEXA-4 for Astra Zeneca; and has received personal fees from Astra Zeneca.

Figures

FIGURE 1
FIGURE 1
Total intracranial hemorrhage (ICrH) volume minimal detectable change (MDC) percentage by hemostatic efficacy.
FIGURE 2
FIGURE 2
Quantomo measurement of intracranial hemorrhage (ICrH) versus hemorrhage volume by compartment.
FIGURE 3
FIGURE 3
(a) Minimal detectable change (MDC) percentage by hemorrhage location. (b) MDC percentage for total intracranial hemorrhage volume.

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