Application of Magnesium-rich Artificial Cerebrospinal Fluid in Aneurysmal Subarachnoid Hemorrhage
Effects of Magnesium-rich Artificial Cerebrospinal Fluid on the Incidence of Cerebral Vasospasm and Clinical Prognosis of Patients With Aneurysmal Subarachnoid Hemorrhage
1 other identifier
interventional
70
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 16, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedMay 10, 2022
March 1, 2022
2.4 years
March 16, 2020
May 6, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Incidence and severity of CVS during and after operation
Transcranial Doppler (TCD) will be used to evaluate the occurrence and severity of CVS, which will be diagnosed according to the following criteria for TCD. First, the mean blood flow velocity of tested arteries is higher than 120cm/s. Second, the mean blood flow velocity of tested arteries increases more than 15cm/s or 20% compared with the previous time. Third, the Lindeggard Index (mean blood flow velocity of MCA/mean blood flow velocity of ipsilateral eICA) is higher than 3
Within 14 days after surgery
mRS (modified Rankin Scale）
Assess patients' prognosis by the score of modified Rankin Scale.In the mRS, the lowest score is 0, and the highest score is 5. A score of 0 indicates the patients have no symptoms at all, and a score of 5 indicates the patients have severe disability, bed rest, incontinence, and need for continuous care and attention. In this study, we evaluate patient's outcomes by the following criteria. Favorable outcome was defined as mRS\<3, whereas poor outcome was mRS≥3.
Day 30
mRS (modified Rankin Scale）
Assess patients' prognosis by the score of modified Rankin Scale.In the mRS, the lowest score is 0, and the highest score is 5. A score of 0 indicates the patients have no symptoms at all, and a score of 5 indicates the patients have severe disability, bed rest, incontinence, and need for continuous care and attention. In this study, we evaluate patient's outcomes by the following criteria. Favorable outcome was defined as mRS\<3, whereas poor outcome was mRS≥3.
Day 60
mRS (modified Rankin Scale）
Assess patients' prognosis by the score of modified Rankin Scale.In the mRS, the lowest score is 0, and the highest score is 5. A score of 0 indicates the patients have no symptoms at all, and a score of 5 indicates the patients have severe disability, bed rest, incontinence, and need for continuous care and attention. In this study, we evaluate patient's outcomes by the following criteria. Favorable outcome was defined as mRS\<3, whereas poor outcome was mRS≥3.
Day 90
Secondary Outcomes (5)
Levels of biomarkers in cerebrospinal fluid (CSF)
Within 14 days after surgery
Levels of ion concentration in cerebrospinal fluid (CSF)
Within 14 days after surgery
Levels of biomarkers in blood
Within 14 days after surgery
Levels of ion concentration in blood
Within 14 days after surgery
Duration of hospitalization
up to 60 days
Other Outcomes (3)
Incidence and severity of MACSF-induced infection
up to 14 days
Fluctuation of intracranial pressure（ICP）
up to 14 days
Incidence of hypermagnesemia
up to 14 days
Study Arms (2)
Historical control group
NO INTERVENTIONThe patients were treated by aneurysm clipping in our hospital in the previous nine months, and normal saline (0.9% Sodium Chloride Injection) had applied as intraoperative perfusion solution in operation of the historical control group. All of the 35 patients selected should meet the inclusion and exclusion criteria of this study.
MACSF group
EXPERIMENTALUse Magnesium-Rich Artificial Cerebrospinal Fluid (MACSF) in the operation, and the remaining treatments should strictly follow the guidelines as same as the historical control group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patient is between 18 and 80 years of old;
- aSAH is diagnosed by CTA, DSA or other cranial imaging examination;
- Patient is admitted to hospital within 72 hours after aSAH onset;
- Aneurysm is clipped within 36 hours after admission;
- Patient and his/her relatives are informed and agree to accept the above treatment plan.
You may not qualify if:
- Cause of the SAH is not rupture of an intracranial aneurysm;
- Time from SAH onset to admission is longer than 72 hours;
- Time from admission to surgery is longer than 36 hours;
- The patient dose not choose clipping;
- Patient has other serious diseases, such as heart failure, kidney failure, liver failure, etc;
- Patient or his/her relatives refuse to accept the above research plan.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
Related Publications (1)
Cheng Y, Han X, Xie W, Xu G, Bai X, Qi L, Zhang L, Liu R, Dong W, Feng W, Pang C, Zhang W, Liu F, Cao X, Xu Y, Luo G. Safety and efficacy of magnesium-rich artificial cerebrospinal fluid for subarachnoid hemorrhage. Front Neurol. 2024 Mar 28;15:1376216. doi: 10.3389/fneur.2024.1376216. eCollection 2024.
PMID: 38606277DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luo Guogang, MD,PHD
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2020
First Posted
April 24, 2020
Study Start
March 1, 2020
Primary Completion
July 30, 2022
Study Completion
July 30, 2022
Last Updated
May 10, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share