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

March 17, 2019 updated by: Zhujiang Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shuai He, Doctor
  • Phone Number: 862062783372
  • Email: hs43555@qq.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ischemic stroke treated with Alteplase

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
experimental group
The patients who were treated with Ateptidase had intracranial haemorrhage adverse reactions
Drug: Ateptidase
Treatment of ischemic stroke with Ateptidase
control group
The patients who were treated with Ateptidase did not have intracranial haemorrhage adverse reactions.
Drug: Ateptidase
Treatment of ischemic stroke with Ateptidase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intracranial hemorrhage
Time Frame: 3 days
The occurrence of intracranial haemorrhage adverse reactions in ischemic stroke patients receiving thrombolytic therapy by alteplase
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Collaborators

Nanfang Hospital of Southern Medical University
First Affiliated Hospital of Jinan University

Investigators

  • Principal Investigator: Shuai He, Doctor, Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 12, 2018

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (ACTUAL)

November 7, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 17, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-YXB-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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