Predictors of Post-alteplase Hemorrhagic Transformation of Brain Infarction

Kafrelsheikh University

Status and phase: Completed; Phase 4

Conditions: Ischemic Stroke; Alteplase Adverse Reaction

Treatments: Drug: Alteplase

Study type: Interventional

Funder types: Other

Identifiers

NCT06337175

000000230988

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The investigators enrolled individuals of both genders, aged between 18 and 75, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis.

Exclusion criteria

• The investigators excluded patients who had not been followed up on for 90 days after enrollment,
• Those with alteplase contraindications or did not receive the total dose of alteplase due to any reason were excluded
• The investigators excluded patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit).
• The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings.
• The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks.
• The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Hemorragic transformation group

Active Comparator group

Description:

One hundred fifty-two acute ischemic stroke (AIS) patients who had hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase.

Treatment:

Drug: Alteplase

Drug: Alteplase

non-hemorragic transformation group

Active Comparator group

Description:

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.

Treatment:

Drug: Alteplase

Drug: Alteplase