Aneurysmal Subarachnoid HemorrhageBLOCK-CVSNCT04691271
Stellate Ganglion Block and Cerebral Vasospasm
A study testing Stellate ganglion block in people with Aneurysmal Subarachnoid Hemorrhage and Stellate Ganglion Block, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
At present, cerebral vasospasm (cVS) is the main cause of delayed cerebral infarction (DCI), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. As a consequence, the key of reducing DCI is to prevent cVS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Stellate Ganglion Block, Cerebral Vasospasm
- What is being tested?
- Stellate ganglion block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 18-65 years old;
- Within 48 hours after onset of aSAH,and planning surgical treatment(aneurysm clipping);
- Preoperative Hunt-Hess grade 2-3
- Sign informed consent.
Who cannot join
- ASA > grade III;
- Patients with posterior circulation aneurysm, ophthalmic aneurysms or internal carotid aneurysms;
- patients with multiple aneurysms;
- Patients with severe coagulation dysfunction;
- Patients with trauma and local infection in the nerve block area;
- Local anatomic structure changes (neck structure changes caused by radiotherapy, chemotherapy and surgery);
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- MCA stenosis or infarction was found by preoperative imaging;
- Patients with poor temporal window signal revealed by preoperative TCD (clear waveform image could not be obtained);
- Allergy to known local anesthetics;
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
Ruquan Han, M.D., Ph.D
About this study
Official title: Effect of Early Stellate Ganglion Block for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial (BLOCK-CVS)
At present, cerebral vasospasm (cVS) is the main cause of delayed cerebral infarction (DCI), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. As a consequence, the key of reducing DCI is to prevent cVS. But unfortunately, despite years of efforts, the prevention and treatment of cVS is still a major clinical dilemma and various ways of treatment are still being explored. Recent studies have shown that stellate ganglion block (SGB) can dilate cerebral vessels and alleviate the impact of existing cVS. However, there is no study to evaluate the effect of early application of SGB on the improvement and prevention of cVS after aSAH.
Read the detailed description
Cerebral vasospasm refers to the extensive segmental or diffuse contraction of cerebral vasculature after aSAH, and cerebral blood flow is significantly reduced, which can lead to delayed cerebral ischemia (DCI) or delayed ischemic neurological dysfunction (DIND). Past studies have shown that if cerebral vasospasm occurs in patients with aSAH, the proportion of ischemic brain injury can be as high as 20%-30%.Obviously, prevention and treatment of CVS are the key to reducing the disability and mortality of aSAH.
- Being tested
- Stellate ganglion block
- Keywords
- Cerebral vasospasm, Stellate ganglion block
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate ganglion blockProcedure or surgery
After the patient entered the operating room, early SGB will be performed by a designated experienced anesthesiologist using the B-ultrasound visualization technique. The intervention site is the ipsilateral side of the planned craniotomy site. After routine disinfection, 0.5% ropivacaine 8-10 mL will be injected into the surface of the longus colli muscle on the medial side of the prevertebral fascia at the level of the C6 anterior tubercle, and then the puncture point will be covered with sterile dressings. The success criteria of e-SGB are Horner's syndrome, which is characterized by a miosis, ptosis, enophthalmos, conjunctival hyperemia and facial reddishness without sweating. For the "camouflaging" arm, the anesthesiologist only covered the corresponding part of the patient with sterile dressings to confuse the follow-up, without any puncture. All patients will be admitted to the ICU after the operation and then receive the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | In addition to routine anesthesia management and surgical operations, a stellate ganglion block was performed before induction of anesthesia, and then receive standard care after operation. Related statistical indicators were collected prospectively. Receives: Procedure: Stellate ganglion block |
| Blank control group | No intervention | In this study, a blank control was used. Routine anesthesia management and surgical operation were used without any special interventions(only an camouflaging action), and then receive standard care after operation. Only relevant statistical indicators were collected prospectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of symptomatic vasospasm during hospitalization
Symptomatic vasospasm is defined as new focal or global neurological dysfunction or a decrease in the Glasgow coma score by more than 2 points, and with angiographic vasospasm on TCD or CTA.
Measured: an average of 2 weeks
Secondary outcomes (12)
The incidence of TCD vasospasm during hospitalization
The mean blood flow velocity (MFV) of the middle cerebral artery ≥ 120 cm/s or Lindegaard index (ratio of MFV of the middle cerebral artery to the internal carotid artery) ≥ 3.
Measured: on the days 3-5 after operation
The incidence of CTA vasospasm on the days 3-5 after operation
Compared with the preoperative baseline, the corresponding vessel diameter narrowed by more than 30% or new segmental stenosis occurred, not related to atherosclerosis or mechanical artery stenosis caused by arterial clamps or coils.
Measured: on the days 3-5 after operation
The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation
The incidence of hypoperfusion in CTP diagnosis
Measured: on the days 3-5 after operation
The incidence of new cerebral infarction observed on the days 90 after operation and discharge .
New cerebral infarction is defined only as the appearance of new low-density infarct shadow on CT image compared with preoperation.
Measured: on the days 90 after operation and discharge
The changes of he mean blood flow velocity (mBFV) after operation
the changes in the mean blood flow velocity (mBFV) of all large intracranial anterior circulation vessels
Measured: on the days 3-5 after operation
Total length of stay in the intensive care unit and hospital.
Days
Measured: on the 90 days
The modified Rankin scale at discharge, 30days, and 90 days
The modified Rankin scale ≤2 is defined as good prognosis
Measured: on the 30 and 90 days
All-cause mortality rate up to 90 days.
The rate
Measured: on the 90 days
Postoperative delirium incidence during hospitalization
The rate
Measured: on the days 1-3 after operation
Postoperative cognitive dysfunction
The rate
Measured: At discharge，an average of 2 weeks
The proportion of remedial treatment after CVS
The rate
Measured: At discharge，an average of 2 weeks
Adverse events during hospitalization
Myocardial infarction, cardiac arrest, pulmonary embolism, infection, SGB related complications, etc
Measured: At discharge，an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Jul 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Beijing Tiantan HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, M.D., Ph.D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691271
- Sponsor's protocol ID
- Z191100006619068
- Acronym
- BLOCK-CVS
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2020
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu Y, Lin F, Bai Y, Liang F, Wang X, Wang B, Jian M, Wang Y, Liu H, Wang A, Chen X, Han R. Early stellate ganglion block for improvement of postoperative cerebral blood flow velocity after aneurysmal subarachnoid hemorrhage: results of a pilot randomized controlled trial. J Neurosurg. 2023 Apr 28;139(5):1339-1347. doi: 10.3171/2023.3.JNS222567. Print 2023 Nov 1.
PubMed 37119094Jing L, Wu Y, Liang F, Jian M, Bai Y, Wang Y, Liu H, Wang A, Chen X, Han R. Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial. Trials. 2022 Nov 4;23(1):922. doi: 10.1186/s13063-022-06867-9.
PubMed 36333751
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Stellate Ganglion Block for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage: a Randomized Controlled Trial (BLOCK-CVS)
- ClinicalTrials.gov ID
- NCT04691271
- Acronym / sponsor ID
- BLOCK-CVS / Z191100006619068
- Keywords
- Cerebral vasospasm, Stellate ganglion block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 31 Dec 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.
At present, cerebral vasospasm (cVS) is the main cause of delayed cerebral infarction (DCI), which leads to high disability and mortality rate after aneurysmal subarachnoid hemorrhage. As a consequence, the key of reducing DCI is to prevent cVS. But unfortunately, despite years of efforts, the prevention and treatment of cVS is still a major clinical dilemma and various ways of treatment are still being explored. Recent studies have shown that stellate ganglion block (SGB) can dilate cerebral vessels and alleviate the impact of existing cVS. However, there is no study to evaluate the effect of early application of SGB on the improvement and prevention of cVS after aSAH.
Detailed description
Cerebral vasospasm refers to the extensive segmental or diffuse contraction of cerebral vasculature after aSAH, and cerebral blood flow is significantly reduced, which can lead to delayed cerebral ischemia (DCI) or delayed ischemic neurological dysfunction (DIND). Past studies have shown that if cerebral vasospasm occurs in patients with aSAH, the proportion of ischemic brain injury can be as high as 20%-30%.Obviously, prevention and treatment of CVS are the key to reducing the disability and mortality of aSAH.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Stellate ganglion blockIn addition to routine anesthesia management and surgical operations, a stellate ganglion block was performed before induction of anesthesia, and then receive standard care after operation. Related statistical indicators were collected prospectively. |
| Blank control group | No intervention | –In this study, a blank control was used. Routine anesthesia management and surgical operation were used without any special interventions(only an camouflaging action), and then receive standard care after operation. Only relevant statistical indicators were collected prospectively. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range: 18-65 years old;
- Within 48 hours after onset of aSAH,and planning surgical treatment(aneurysm clipping);
- Preoperative Hunt-Hess grade 2-3
- Sign informed consent.
Key exclusion criteria (10 listed)
- ASA > grade III;
- Patients with posterior circulation aneurysm, ophthalmic aneurysms or internal carotid aneurysms;
- patients with multiple aneurysms;
- Patients with severe coagulation dysfunction;
- Patients with trauma and local infection in the nerve block area;
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 |
|---|---|---|
| Stellate ganglion blockAfter the patient entered the operating room, early SGB will be performed by a designated experienced anesthesiologist using the B-ultrasound visualization technique. The intervention site is the ipsilateral side of the planned craniotomy site. After routine disinfection, 0.5% ropivacaine 8-10 mL will be injected into the surface of the longus colli muscle on the medial side of the prevertebral fascia at the level of the C6 anterior tubercle, and then the puncture point will be covered with sterile dressings. The success criteria of e-SGB are Horner's syndrome, which is characterized by a miosis, ptosis, enophthalmos, conjunctival hyperemia and facial reddishness without sweating. For the "camouflaging" arm, the anesthesiologist only covered the corresponding part of the patient with sterile dressings to confuse the follow-up, without any puncture. All patients will be admitted to the ICU after the operation and then receive the standard of care. | Procedure or surgery | Intervention group |
Primary outcome
The incidence of symptomatic vasospasm during hospitalization
Time frame: an average of 2 weeks
Symptomatic vasospasm is defined as new focal or global neurological dysfunction or a decrease in the Glasgow coma score by more than 2 points, and with angiographic vasospasm on TCD or CTA.
12 secondary outcomes
The incidence of TCD vasospasm during hospitalization
Time frame: on the days 3-5 after operation
The incidence of CTA vasospasm on the days 3-5 after operation
Time frame: on the days 3-5 after operation
The incidence of hypoperfusion in CTP diagnosis on the days 3-5 after operation
Time frame: on the days 3-5 after operation
The incidence of new cerebral infarction observed on the days 90 after operation and discharge .
Time frame: on the days 90 after operation and discharge
The changes of he mean blood flow velocity (mBFV) after operation
Time frame: on the days 3-5 after operation
Total length of stay in the intensive care unit and hospital.
Time frame: on the 90 days
The modified Rankin scale at discharge, 30days, and 90 days
Time frame: on the 30 and 90 days
All-cause mortality rate up to 90 days.
Time frame: on the 90 days
Postoperative delirium incidence during hospitalization
Time frame: on the days 1-3 after operation
Postoperative cognitive dysfunction
Time frame: At discharge，an average of 2 weeks
The proportion of remedial treatment after CVS
Time frame: At discharge，an average of 2 weeks
Adverse events during hospitalization
Time frame: At discharge，an average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 37119094Wu Y, Lin F, Bai Y, Liang F, Wang X, Wang B, Jian M, Wang Y, Liu H, Wang A, Chen X, Han R. Early stellate ganglion block for improvement of postoperative cerebral blood flow velocity after aneurysmal subarachnoid hemorrhage: results of a pilot randomized controlled trial. J Neurosurg. 2023 Apr 28;139(5):1339-1347. doi: 10.3171/2023.3.JNS222567. Print 2023 Nov 1.
- Derived from this study: PubMed 36333751Jing L, Wu Y, Liang F, Jian M, Bai Y, Wang Y, Liu H, Wang A, Chen X, Han R. Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial. Trials. 2022 Nov 4;23(1):922. doi: 10.1186/s13063-022-06867-9.
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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.
Ruquan Han, M.D., Ph.D principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stellate ganglion block in people with Aneurysmal Subarachnoid Hemorrhage and Stellate Ganglion Block, run by Beijing Tiantan Hospital 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 4 inclusion and 10 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 15 Mar 2024. 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 Ruquan Han, M.D., Ph.D (8610-59976660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of symptomatic vasospasm during hospitalization (time frame: an average of 2 weeks). 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 NCT04691271, which also lists 2 linked publications.
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 15 Mar 2024.