Effect of Different Heparinization Schemes on Prognosis of Intracranial Aneurysm

Not Applicable

Recruiting

• Conditions: Intracranial Aneurysm
• Interventions: Drug: Heparin sodium

• Registration Number: NCT05749393
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-01
• Study Start: 2023-04-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-22
• Primary Completion: 2024-03-31
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose group	Heparin sodium	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.
High-dose group	Heparin sodium	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.

Primary Outcome Measures

Name	Time	Method
Size of the ischemic focus	This will be evaluated within 24 hours after the procedure.	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.

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, China