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Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm (EODHS-IA)

Primary Purpose

Intracranial Aneurysm

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Heparin sodium
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Intracranial Aneurysm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Greater than 18 years old, less than 75 years old Patients with unruptured intracranial aneurysm were confirmed by DSA. Coagulation function should be normal in the enrolled patients. Exclusion Criteria: Dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation. Previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Low-dose group

    Medium dose group

    High-dose group

    Arm Description

    The initial dose was 50U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure.

    The initial dose was 60U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure.

    The initial dose was 70U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure.

    Outcomes

    Primary Outcome Measures

    Size of the ischemic focus
    Cranial MRI will be performed on postoperative patients within 24 hours. The presence of high signal on diffusion weighted imaging sequences indicated the occurrence of cerebral infarction.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    April 12, 2023
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05749393
    Brief Title
    Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm
    Acronym
    EODHS-IA
    Official Title
    Effect of Heparinization on Intracranial Aneurysm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 30, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    April 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare intracranial aneurysm patients. The main question it aims to answer are: Which heparinization regimen is most beneficial to patients during surgery for intracranial aneurysms. Participants will be randomized to different intraoperative heparinization regimens: (i) 50 U/kg intravenous (IV) at 1-h intervals reduced by half to a minimum of 1000 u/h; (ii) 60 U/kg IV at 1-h intervals reduced by half to a minimum of 1000 u/h; (iii) 70 U/kg IV at 1-h intervals reduced by half to a minimum of 1000 u/h. MRI will be performed within 72 h after surgery, and the DWI sequence of MRI will be analyzed. If there is a comparison group: Researchers will compare different intraoperative heparinization protocol groups to see which dose of intraoperative heparin has the best prognosis for use.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracranial Aneurysm
    Keywords
    Intracranial Aneurysm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Low-dose group
    Arm Type
    Experimental
    Arm Description
    The initial dose was 50U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure.
    Arm Title
    Medium dose group
    Arm Type
    Experimental
    Arm Description
    The initial dose was 60U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure.
    Arm Title
    High-dose group
    Arm Type
    Experimental
    Arm Description
    The initial dose was 70U/kg intravenous injection, and the dosage was halved by intravenous injection every 1 hour to the minimum 1000u/h. The medication will be discontinued at the end of the procedure.
    Intervention Type
    Drug
    Intervention Name(s)
    Heparin sodium
    Intervention Description
    Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.
    Primary Outcome Measure Information:
    Title
    Size of the ischemic focus
    Description
    Cranial MRI will be performed on postoperative patients within 24 hours. The presence of high signal on diffusion weighted imaging sequences indicated the occurrence of cerebral infarction.
    Time Frame
    This will be evaluated within 24 hours after the procedure.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Greater than 18 years old, less than 75 years old Patients with unruptured intracranial aneurysm were confirmed by DSA. Coagulation function should be normal in the enrolled patients. Exclusion Criteria: Dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation. Previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hua Lu, Doctor
    Phone
    18761671021
    Email
    luhua@njmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hua Lu, Doctor
    Organizational Affiliation
    First Affiliated Hospital, Nanjing Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Individual participant data (IPD) will be available to other researchers under the approval of the ethical committee.
    IPD Sharing Time Frame
    the data will be available when summary data are published.
    Citations:
    PubMed Identifier
    33424758
    Citation
    Zhang L, Zhou X, Liu Y, Ding C, Wang Y, Yang H. The Utility of Diffusion-Weighted MRI Lesions to Compare the Effects of Different Heparinization Schemes in Intracranial Aneurysms Treated by Endovascular Intervention. Front Neurol. 2020 Dec 10;11:609384. doi: 10.3389/fneur.2020.609384. eCollection 2020.
    Results Reference
    background
    PubMed Identifier
    29490066
    Citation
    Narata AP, Amelot A, Bibi R, Herbreteau D, Angoulvant D, Gruel Y, Janot K. Dual Antiplatelet Therapy Combining Aspirin and Ticagrelor for Intracranial Stenting Procedures: A Retrospective Single Center Study of 154 Consecutive Patients With Unruptured Aneurysms. Neurosurgery. 2019 Jan 1;84(1):77-83. doi: 10.1093/neuros/nyy002.
    Results Reference
    background

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    Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm

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