Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm

Intracranial Aneurysm Clinical Trial

— EODHS-IA  

Official title:

Effect of Heparinization on Intracranial Aneurysm

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749393
• Other study ID #: EODHS-IA
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Hua Lu, Doctor
• Phone: 18761671021
• Email: luhua[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: April 1, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Intervention

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

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.