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Application of Magnesium-rich Artificial Cerebrospinal Fluid in Aneurysmal Subarachnoid Hemorrhage

NCT04358445 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-05-10

No results posted yet for this study

Summary

Aneurysmal subarachnoid hemorrhage (aSAH) is a common type of acute hemorrhagic stroke. One of its complications, cerebral vasospasm (CVS), is the main cause of death and disability, with an incidence of up to 30%-90%. Blood and its metabolites are vital reasons for CVS. Normal saline, as an intraoperative irrigation fluid for the surgery of aneurysm clipping, can induce secondary damage to the brain. In this study, a new type of magnesium-rich artificial cerebrospinal fluid (MACSF) has been designed, which has similar ionic concentration, pH value and osmotic pressure compared with the physiological cerebrospinal fluid. It has been confirmed by animal experiments that MACSF can relieve the hyper-responsiveness of cerebral arteries to ET and 5-HT induced by hemorrhagic CSF from patients with aSAH by down-regulating the expression of ETA, contractile ETB and 5-HT1B receptors in the previous research. Therefore, MACSF may have potential effects on preventing and treating CVS. In this study, we plan to apply MACSF as an intraoperative irrigation fluid for the surgery of aneurysm clipping (MACSF group), which is compared with normal saline (historical control group). To evaluate the effects of MACSF on reducing the incidence of CVS and improving the clinical prognosis of patients with aSAH, the occurrence of CVS within 14 days after aneurysm clipping, NIHSS score, as well as mRS scores at 1, 3 and 6 months after aSAH will be recorded and compared. CVS related biomarkers will be used to evaluate the relationship between the occurrence of CVS and the levels of biomarkers in both CSF and blood samples from MACSF group.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage

Interventions

OTHER

Magnesium-Rich Artificial Cerebrospinal Fluid

The Magnesium-Rich Artificial Cerebrospinal Fluid (MACSF) is composed of several qualified clinical intravenous injections according to a specific formula, which has similar physical and chemical properties to physiological CSF. MACSF will be freshly made and used. It will be prepared by trained professionals on a specific workbench and sent to the operating room in a special container. Finally, it will be used in the operation by the neurosurgeons. Aseptic principles should be enforced strictly during the whole procedures, including preparation, transportation and application.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Luo Guogang, MD,PHD · First Affiliated Hospital Xi'an Jiaotong University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-07-30
Completion
2022-07-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358445 on ClinicalTrials.gov