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

Nanjing Medical University

Status: Enrolling

Conditions: Intracranial Aneurysm

Treatments: Drug: Heparin sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT05749393

EODHS-IA

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Low-dose group

Experimental group

Description:

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.

Treatment:

Drug: Heparin sodium

High-dose group

Experimental group

Description:

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.

Treatment:

Drug: Heparin sodium