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

Effect of Heparinization on Intracranial Aneurysm

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) 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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Drug: Heparin sodium

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hua Lu, Doctor; Phone Number: 18761671021; Email: luhua@njmu.edu.cn

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • Jiangsu Province Hospital
    • Contact: Hua Lu; Phone Number: +8618761671021; Email: luhua@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Greater than 18 years old, less than 75 years old
2. Patients with unruptured intracranial aneurysm were confirmed by DSA.
3. Coagulation function should be normal in the enrolled patients.

Exclusion Criteria:

1. Dissection aneurysm, blister aneurysm, moyamoya disease or arteriovenous malformation.
2. Previous use of antithrombotic drugs (including anticoagulant or antiplatelet aggregation drugs).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-dose group; 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.	Drug: Heparin sodium; Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.
Experimental: High-dose group; 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.	Drug: Heparin sodium; Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	This will be evaluated within 24 hours after the procedure.

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Hua Lu, Doctor, First Affiliated Hospital, Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Intracranial Aneurysm
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: EODHS-IA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• 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