Aneurysmal Subarachnoid HemorrhageNCT04358445
Application of Magnesium-rich Artificial Cerebrospinal Fluid in Aneurysmal Subarachnoid Hemorrhage
A study testing Magnesium-Rich Artificial Cerebrospinal Fluid in people with Aneurysmal Subarachnoid Hemorrhage, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Magnesium-Rich Artificial Cerebrospinal Fluid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061
Guogang Luo, Ph.D., 86-13991974085
About this study
Official title: Effects of Magnesium-rich Artificial Cerebrospinal Fluid on the Incidence of Cerebral Vasospasm and Clinical Prognosis of Patients With Aneurysmal Subarachnoid Hemorrhage
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.
Read the detailed description
From now on, participants who meet the inclusion and exclusion criteria in our hospital will be recruited in the intervention group, if they and their relatives are willing to join in the study. For the historical control group, in which patients were treated by aneurysm clipping in Department of Neurosurgery of the First Affiliated Hospital of Xi'an Jiaotong University during the previous nine months, normal saline (0.9% Sodium Chloride Injection) was applied as intraoperative perfusion solution for their operation. For the intervention group, MACSF will be used. (The composition and concentration of MACSF is as follows: Na+: 146.2 mEq/l, K+: 2.7 mEq/l, Mg2+: 4.2 mEq/l, Cl-: 123 mEq/l, HCO3-: 23.2 mEq/l, Glucose: 0.75 g/l. MACSF is prepared by the staff of Pharmacy Intravenous Admixture Services of First Affiliated Hospital of Xi'an Jiaotong University, according to a specific formula in the specific working area. The whole procedure follow the aseptic principles strictly. Fresh-made MACSF will be placed in a specific container and send to the operating room through specific channels.) Then, for the patients who have signed the informed consent, blood (6ml) and CSF (3ml) samples will be collected during and every other day after the surgery for 14 days. The blood samples should be drawn into a non-anticoagulant tube and a heparin anticoagulant tube respectively. All the samples will be transferred to BioBank of the First Affiliated Hospital of Xi'an Jiaotong University in a liquid nitrogen tank. After re-melted in a water bath of 37℃, the CSF and blood samples will be centrifuged at 4℃ for 10min at 2000r/min, and then the supernatant will be collected and stored at -80℃. At the end of this study, the contents of NPY，MMP-9，MIF，TNF-α，Mg2+ and Ca2+in the samples will be detected by ELISA or mass spectrometry. Transcranial Doppler (TCD) will be observed within 14 days after the operation (daily for the first three days and every other day for the following days). CVS will be diagnosed by TCD, the diagnostic criteria will be described later. CT scan of the brain should be done at least once a week and rechecked anytime when necessary. If there is new low-density lesions, delayed cerebral infarction (DCI) will be diagnosed. The prognosis will be assessed at 1, 3 and 6 months after aSAH onset according to modified Rankin Scale (mRS) . Meanwhile, some indicators will be used to evaluate the safety of MACSF application, which incluiding secondary infection, fluctuation of intracranial pressure and hypermagnesemia. The diagnostic criteria and the solutions will be described in the next part.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Magnesium-Rich Artificial Cerebrospinal Fluid
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium-Rich Artificial Cerebrospinal FluidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Historical control group | No intervention | The 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 | Experimental | Use 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. Receives: Other: Magnesium-Rich Artificial Cerebrospinal Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 90
Secondary outcomes (5)
Levels of biomarkers in cerebrospinal fluid (CSF)
Cerebrospinal fluid samples were collected during and every other day after surgery for 14 days to evaluated the effect of MACSF on Neuropeptide Y (NPY, ng/L), Matrix Metalloproteinase-9(MMP-9, ng/L), Macrophage Migration Inhibitory Factor (MIF, ng/L), Tumor Necrosis Factor-α(TNF-α, ng/L).
Measured: Within 14 days after surgery
Levels of ion concentration in cerebrospinal fluid (CSF)
Cerebrospinal fluid samples were collected during and every other day after surgery for 14 days to evaluated the effect of MACSF on Mg2+ (mEq/L)and Ca2+ (mEq/L).
Measured: Within 14 days after surgery
Levels of biomarkers in blood
Blood samples were collected during and every other day after surgery for 14 days to evaluated the effect of MACSF on Neuropeptide Y (NPY, ng/L), Matrix Metalloproteinase-9(MMP-9, ng/L), Macrophage Migration Inhibitory Factor (MIF, ng/L), Tumor Necrosis Factor-α(TNF-α, ng/L).
Measured: Within 14 days after surgery
Levels of ion concentration in blood
Blood samples were collected during and every other day after surgery for 14 days to evaluated the effect of MACSF on Mg2+ (mEq/L)and Ca2+ (mEq/L).
Measured: Within 14 days after surgery
Duration of hospitalization
Length of hospital stay in the intensive care unit, total length of hospital stay, the days of anti-CVS drugs use, etc
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Mar 2020
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Non randomized， non parallelized and history case-controled quasi-experiment
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luo Guogang, MD,PHD, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358445
- Sponsor's protocol ID
- XJYFY-2019N28
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 38606277
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium-rich Artificial Cerebrospinal Fluid on the Incidence of Cerebral Vasospasm and Clinical Prognosis of Patients With Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT04358445
- Acronym / sponsor ID
- XJYFY-2019N28
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
From now on, participants who meet the inclusion and exclusion criteria in our hospital will be recruited in the intervention group, if they and their relatives are willing to join in the study. For the historical control group, in which patients were treated by aneurysm clipping in Department of Neurosurgery of the First Affiliated Hospital of Xi'an Jiaotong University during the previous nine months, normal saline (0.9% Sodium Chloride Injection) was applied as intraoperative perfusion solution for their operation. For the intervention group, MACSF will be used. (The composition and concentration of MACSF is as follows: Na+: 146.2 mEq/l, K+: 2.7 mEq/l, Mg2+: 4.2 mEq/l, Cl-: 123 mEq/l, HCO3-: 23.2 mEq/l, Glucose: 0.75 g/l. MACSF is prepared by the staff of Pharmacy Intravenous Admixture Services of First Affiliated Hospital of Xi'an Jiaotong University, according to a specific formula in the specific working area. The whole procedure follow the aseptic principles strictly. Fresh-made MACSF will be placed in a specific container and send to the operating room through specific channels.) Then, for the patients who have signed the informed consent, blood (6ml) and CSF (3ml) samples will be collected during and every other day after the surgery for 14 days. The blood samples should be drawn into a non-anticoagulant tube and a heparin anticoagulant tube respectively. All the samples will be transferred to BioBank of the First Affiliated Hospital of Xi'an Jiaotong University in a liquid nitrogen tank. After re-melted in a water bath of 37℃, the CSF and blood samples will be centrifuged at 4℃ for 10min at 2000r/min, and then the supernatant will be collected and stored at -80℃. At the end of this study, the contents of NPY，MMP-9，MIF，TNF-α，Mg2+ and Ca2+in the samples will be detected by ELISA or mass spectrometry. Transcranial Doppler (TCD) will be observed within 14 days after the operation (daily for the first three days and every other day for the following days). CVS will be diagnosed by TCD, the diagnostic criteria will be described later. CT scan of the brain should be done at least once a week and rechecked anytime when necessary. If there is new low-density lesions, delayed cerebral infarction (DCI) will be diagnosed. The prognosis will be assessed at 1, 3 and 6 months after aSAH onset according to modified Rankin Scale (mRS) . Meanwhile, some indicators will be used to evaluate the safety of MACSF application, which incluiding secondary infection, fluctuation of intracranial pressure and hypermagnesemia. The diagnostic criteria and the solutions will be described in the next part.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non randomized， non parallelized and history case-controled quasi-experiment
| Arm | Type | Receives |
|---|---|---|
| Historical control group | No intervention | –The 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 | Experimental | Other: Magnesium-Rich Artificial Cerebrospinal FluidUse 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium-Rich Artificial Cerebrospinal FluidThe 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. | Other | MACSF group |
Primary outcome
Incidence and severity of CVS during and after operation
Time frame: Within 14 days after surgery
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
mRS (modified Rankin Scale）
Time frame: Day 30
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.
mRS (modified Rankin Scale）
Time frame: Day 60
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.
mRS (modified Rankin Scale）
Time frame: Day 90
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.
5 secondary outcomes
Levels of biomarkers in cerebrospinal fluid (CSF)
Time frame: Within 14 days after surgery
Levels of ion concentration in cerebrospinal fluid (CSF)
Time frame: Within 14 days after surgery
Levels of biomarkers in blood
Time frame: Within 14 days after surgery
Levels of ion concentration in blood
Time frame: Within 14 days after surgery
Duration of hospitalization
Time frame: up to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 38606277Cheng 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luo Guogang, MD,PHD principal investigator
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium-Rich Artificial Cerebrospinal Fluid in people with Aneurysmal Subarachnoid Hemorrhage, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han Xiangning (0086-18392002455, hxiangning@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of CVS during and after operation (time frame: Within 14 days after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04358445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.