Relationships Among FVIII, t-PA/PAI-1, and MMP-9 Levels and Intracranial Hemorrhage Complications After Thrombolysis With Alteplase in Patients With Acute Ischemic Stroke: Protocol for a Multicenter Retrospective Study

Zhujiang Hospital

Status

Unknown

Conditions

Ischemic Stroke

Treatments

Drug: Ateptidase

Study type

Observational

Funder types

Other

Identifiers

NCT03733223

2018-YXB-002

Details and patient eligibility

About

The primary aim of the study is to investigate the relationships among FVIII, t-PA/PAI-1, MMP-9 levels, and intracranial hemorrhage after thrombolysis with alteplase using a combined analysis.

Full description

Patients with acute ischemic stroke treated with alteplase within 4.5 hours after the onset of stroke symptoms will be recruited in this study. All participants will be divided into two groups according to whether intracranial hemorrhage occurred within 3 days after treatment with alteplase for analysis. Differences in FVIII, t-PA/PAI-1, and MMP-9 levels before and after thrombolytic therapy will be examined in both groups. This study will be conducted at Zhujiang Hospital of Southern Medical University, Nanfang Hospital of Southern Medical University, and the First Affiliated Hospital of Jinan University.

Enrollment

350 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of ischemic stroke and within the time window of thrombolysis (Onset of symptoms no more than 4.5 hours )
18 y age 85 y•
Symptoms of neurological deficits caused by cerebral infarction
Informed consent form to confirm thrombolytic therapy have signed by patients or their family.

Exclusion criteria

A history of major head trauma or stroke in the past 3 months
Suspicious subarachnoid hemorrhage
Arterial puncture at noncompressible site in the last week
History of intracranial hemorrhage
Intracranial neoplasm, arteriovenous malformation, or aneurysm
Recent intracranial or intraspinal surgery
Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg)
Active internal bleeding or Acute bleeding diathesis
Platelet count <100×109·L-1
Heparin received within 48 h resulting in aPTT above the upper limit of normal
Current use of anticoagulant with INR >1.7 or PT >15 s
Current use of thrombin inhibitors or factor Xa inhibitors
Abnormal laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
Blood glucose concentration > 2.7 mmol/L
CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere)
Mild cerebral infarction or rapid improvement of symptoms of cerebral infarction
Symptoms of neurological impairment after seizures
Major surgery or severe trauma in the past 2 weeks
Gastrointestinal or urinary bleeding in the past 3 weeks
History of myocardial infarction in the past 3 months
Combine diseases that may affect outcomes,such as Anemia, hemophilia
History of autoimmune disease or organ transplantation
Pregnancy or breastfeeding women