Data from: The effect of DL-3-n-butylphthalide on cerebral microbleed development after acute ischemic stroke: A prospective randomized controlled trial
Data files
Jul 29, 2026 version files 28.72 KB
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NBP-updated_data.xlsx
24.89 KB
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README.md
3.83 KB
Abstract
This dataset contains individual participant-level data from a prospective, single-center, parallel-group, double-blind, placebo-controlled randomized trial conducted at Jingjiang People's Hospital, China, between July 2020 and September 2023. The trial was designed to evaluate whether butylphthalide (NBP) injection reduces the incidence and volume of new cerebral microbleeds (CMBs) in patients with acute ischemic stroke (AIS).
The dataset includes baseline demographic and clinical characteristics, admission National Institutes of Health Stroke Scale (NIHSS) scores, treatment allocation (NBP or placebo), laboratory parameters, and imaging data from susceptibility-weighted imaging (SWI) performed at baseline and at 10–14 days post-stroke onset. Outcome variables include the presence and total volume of new CMBs on follow-up SWI, NIHSS score at discharge, occurrence of symptomatic intracranial hemorrhage (sICH) within 90 days, and modified Rankin Scale (mRS) scores at 3 months, including the proportion of patients achieving favorable functional outcomes (mRS 0–2).
Eligibility criteria encompassed patients aged >18 years with AIS diagnosed by CT or MRI, admitted within 24 hours of symptom onset, with baseline NIHSS scores between 4 and 25, and able to undergo two MRI examinations. Exclusion criteria included pre-stroke mRS >1, prior NBP use, receipt of thrombolysis or thrombectomy during hospitalization, atrial fibrillation, use of prohibited concomitant medications, history of intracranial hemorrhage or coagulopathy, severe organ dysfunction, and other specified conditions.
Dataset DOI: 10.5061/dryad.j3tx95xxb
Description of the data and file structure
These data were collected as part of a prospective, randomized controlled trial evaluating the effects of butylphthalide treatment in patients with acute ischemic stroke. Clinical characteristics, susceptibility-weighted imaging findings, newly developed cerebral microbleeds, neurological deficit scores, and 3-month functional outcomes were recorded to assess the efficacy and safety of butylphthalide therapy.
Files and variables
File: NBP-updated_data.xlsx
Description:
This Excel file contains the de-identified participant-level dataset used in the study. The workbook contains one worksheet, named Sheet1, with data from 200 participants and 21 variables. Each row represents one participant, and the first row contains the variable names. No names, medical record numbers, contact details, or other direct personal identifiers are included.
Variables
GroupGenderAge(y)NBPAdmission CMBsAdmission CMBs volume(mm3)Newly diagnosed CMBsNewly diagnosed CMBs volume(mm3)Location of new CMBsSymptomatic intracranial hemorrhageHospitalization daysHypertensionDiabetesAtrial fibrillationCoronary heart diseaseValvular heart diseaseHypercholesterolemiaStrokeBaseline NIHSS scoremRSFavorable outcome(3m-mRS 0-2)
Abbreviations
NBP, butylphthalide; CMB, cerebral microbleed; NIHSS, National Institutes of Health Stroke Scale; mRS, modified Rankin Scale; mm³, cubic millimeters.
Missing values
Missing or non-applicable values are represented by blank cells.
For participants without cerebral microbleeds at admission, the corresponding admission CMB volume field is left blank. For participants without newly occurring cerebral microbleeds on follow-up imaging, the corresponding new CMB volume and location fields are left blank. Therefore, these blank cells indicate that the variables were not applicable rather than that data were unavailable.
Code/software
The submitted dataset is provided as a Microsoft Excel workbook (NBP-updated_data.xlsx). No proprietary software is required to view the data.
Access information
Other publicly accessible locations of the data:
- The dataset has not been deposited in any other publicly accessible repository or data-sharing platform. The data are made available only through the current repository.
Data was derived from the following sources:
- The dataset was generated directly from the study and was not derived from any external database, publicly available dataset, or third-party source. Therefore, no external data licenses apply.
Human subjects data
All participants provided written informed consent that explicitly included permission for their de-identified research data to be published and made available in the public domain. Before data sharing, all direct personal identifiers, including names, identification numbers, contact information, medical record numbers, addresses, and other identifying information, were removed. Each participant was assigned a non-identifiable study code, and the linkage between the study code and the participant’s identity was not included in the shared dataset. Free-text fields and other information that could reasonably permit participant re-identification were removed or generalized where necessary. The resulting dataset contains only de-identified clinical and research variables and does not allow individual participants to be readily identified.
This dataset was collected from a randomized, double-blind, placebo-controlled trial at Jingjiang People's Hospital (July 2020 – September 2023). AIS patients were randomly assigned (1:1) to receive NBP injection or placebo for 10–14 days.
Data collected include:
- Baseline demographics, clinical characteristics, admission NIHSS scores, and laboratory parameters
- SWI MRI scans at baseline and at 10–14 days post-stroke for CMB assessment
- Clinical outcomes: NIHSS at discharge, sICH within 90 days, and mRS at 3 months
Image processing: Two blinded neuroradiologists independently evaluated SWI images for new CMBs; disagreements resolved by consensus.
Data were recorded on standardized case report forms and double-entered into an electronic database with range checks for quality control. All participant identifiers were removed to ensure anonymity.