Clinical trial NCT03733223: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: t-PA/PAI-1
MMP-9
FVIII
Alteplase
intracranial haemorrhage
Ischemic stroke
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: First Affiliated Hospital of Jinan University
First posted: 2018-11-07
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic stroke treated with Alteplase

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intracranial hemorrhage
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Shuai He, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Y, Liao X, Zhao X, Wang DZ, Wang C, Nguyen-Huynh MN, Zhou Y, Liu L, Wang X, Liu G, Li H, Wang Y; China National Stroke Registry Investigators. Using recombinant tissue plasminogen activator to treat acute ischemic stroke in China: analysis of the results from the Chinese National Stroke Registry (CNSR). Stroke. 2011 Jun;42(6):1658-64. doi: 10.1161/STROKEAHA.110.604249. Epub 2011 Apr 21.