Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm

NCT05749393 | Unknown

• 1 other identifier: EODHS-IA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Intracranial Aneurysm

Keywords

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Low-dose group

EXPERIMENTAL

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

High-dose group

EXPERIMENTAL

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

Interventions

Heparin sodium DRUG

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

High-dose group; Low-dose group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Jiangsu Province Hospital

Nanjing, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 33424758 BACKGROUND

• 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.

  PMID: 29490066 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Heparin

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Hua Lu, Doctor

  First Affiliated Hospital, Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hua Lu, Doctor

CONTACT

18761671021; luhua@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 1, 2023
• Study Start: April 30, 2023
• Primary Completion: March 31, 2024
• Study Completion: April 1, 2024
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: the data will be available when summary data are published.

Locations

CN (1)