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The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
Investigators conducted a prospective cohort study between June 2021 and October 2023. They screened 1450 patients who presented with AIS and received alteplase and included 616 AIS patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination, and specific brain imaging results and treated with alteplase within four and half hours of stroke onset.
The investigators assessed the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase.
The study consisted of two distinct groups. The first group consisted of 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction.
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemorragic transformation group | Active Comparator | One hundred fifty-two acute ischemic stroke (AIS) patients who had hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase. |
|
| non-hemorragic transformation group | Active Comparator | Four hundred sixty-four acute ischemic stroke (AIS) patients did not have a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase | Drug | Following the guidelines set by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit. |
| Measure | Description | Time Frame |
|---|---|---|
| predictors of the hemorrhagic infarction type 1 | The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict hemorrhagic infarction type 1 after 24-36 hours of receiving alteplase after acute ischemic stroke. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| predictors of the hemorrhagic infarction type 2 | The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict hemorrhagic infarction type 1 after 24-36 hours of receiving alteplase after acute ischemic stroke. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| mohamed G. Zeinhom, MD | neurology department kafr el-sheikh university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafr Elsheikh University Hospital | Kafr ash Shaykh | 33155 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16731270 | Result | Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9. | |
| 34515113 | Result | Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30. |
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All the data supporting this research's findings may be available from the principal investigator, Mohamed G. Zeinhom, upon reasonable request.
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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The study consisted of two distinct groups. The first group comprised 464 patients who did not experience hemorrhagic infarction, while the second group comprised 152 patients who experienced hemorrhagic infarction.
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|
| Alteplase | Drug | Following the guidelines set by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit. |
|
| predictors of the parenchymal hematoma type 1 |
The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict parenchymal hematoma type 1 after 24-36 hours of receiving alteplase after acute ischemic stroke. |
| 48 hours |
| predictors of the parenchymal hematoma type 2 | The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict parenchymal hematoma type 2 after 24-36 hours of receiving alteplase after acute ischemic stroke. | 48 hours |
| 12221155 | Result | Bruno A, Levine SR, Frankel MR, Brott TG, Lin Y, Tilley BC, Lyden PD, Broderick JP, Kwiatkowski TG, Fineberg SE; NINDS rt-PA Stroke Study Group. Admission glucose level and clinical outcomes in the NINDS rt-PA Stroke Trial. Neurology. 2002 Sep 10;59(5):669-74. doi: 10.1212/wnl.59.5.669. |
| 36446950 | Result | Aref HM, El-Khawas H, Elbassiouny A, Shokri HM, Zeinhom MG, Roushdy TM. A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke. Neurol Sci. 2023 Feb;44(2):765-771. doi: 10.1007/s10072-022-06525-7. Epub 2022 Nov 30. |
| 39616189 | Derived | Zeinhom MG, Ahmed SR, Kohail AM, Kamel IFM, Abdelrahman AM, Al-Nozha OM, Almoataz M, Youssif TYO, Daabis AMA, Refat HM, Ebied AAMK, Elbassiouny A, Akl AZO, Shuaib A, Ismaiel M, Ibrahem AIDM, Khalil MFE. A multicenter trial on the predictors of different subtypes of hemorrhagic infarction after thrombolysis. Sci Rep. 2024 Nov 30;14(1):29822. doi: 10.1038/s41598-024-76189-0. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |