Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm

NCT ID: NCT05749393

Last Updated: 2023-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-30

Study Completion Date

2024-04-01

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Aneurysm

Keywords

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Intracranial Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Heparin sodium

Intervention Type DRUG

Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.

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.

Group Type EXPERIMENTAL

Heparin sodium

Intervention Type DRUG

Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.

Interventions

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Heparin sodium

Intravenous heparin was administered during intracranial aneurysm embolization with a guide catheter and discontinued at the end of the procedure.

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Lu Hua

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hua Lu, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Nanjing Medical University

Locations

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Jiangsu Province Hospital

Nanjing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Lu, Doctor

Role: CONTACT

Phone: 18761671021

Email: [email protected]

Facility Contacts

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Hua Lu

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33424758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29490066 (View on PubMed)

Other Identifiers

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EODHS-IA

Identifier Type: -

Identifier Source: org_study_id