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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03733223
Enrollment
350
Registered
2018-11-07
Start date
2018-10-12
Completion date
2020-12-31
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

t-PA/PAI-1, MMP-9, FVIII, Alteplase, intracranial haemorrhage, Ischemic stroke

Brief summary

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.

Detailed 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.

Interventions

DRUGAteptidase

Treatment of ischemic stroke with Ateptidase

Sponsors

Nanfang Hospital, Southern Medical University
CollaboratorOTHER
First Affiliated Hospital of Jinan University
CollaboratorOTHER
Zhujiang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intracranial hemorrhage3 daysThe occurrence of intracranial haemorrhage adverse reactions in ischemic stroke patients receiving thrombolytic therapy by alteplase

Countries

China

Contacts

Primary ContactShuai He, Doctor
hs43555@qq.com862062783372

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026