Chronic Subdural HematomaTOSCANNCT01624545
To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation
A study testing cranial CT scan in people with Chronic Subdural Hematoma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- cranial CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2012to 6 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours
- Age 18 years or older
- Written informed consent from the patient to participate in the study
Who cannot join
- Moribund state of health prohibiting surgery
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
- Recurrent hematoma if the first surgery was performed before study start
- CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa
- Pregnancy
- Patient with Metastatic Disease and a high possibility to pass away in the next 6 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation - a Prospective, Randomized, Controlled Trial
Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.
The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.
The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.
Read the detailed description
Background
Chronic subdural hematoma (CSH) is one of the most common intracranial bleedings in patients over 60 years of age and a frequently found neurosurgical entity. Age related brain atrophy leads to enlargement of the subarachnoid space, a space limited by the dura mater and the arachnoid membrane. Blood vessels that occupy this space are being stretched and may rupture after a minor head trauma. Although the resulting bleeding itself is often without noticeable consequence for the patient, the anatomical outcome may be serious as it enlarges the subdural space. The formation of new leaky capillary-like vessels and/or volume enhancing osmotic gradients lead to the enlargement of the subdural hematoma over weeks, filling the intracranial space and compressing the brain. Headaches, gait disturbances, language problems, hemiparesis and decreased consciousness are among the many presenting symptoms and tend to develop over days or weeks.
Computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head typically reveals the blood accumulation in the subdural space. Standard treatment includes the evacuation of the subdural blood through burr holes (see below) under either local or general anesthesia. In cases when a hematoma clot cannot be evacuated through burr holes a small craniotomy is performed. CSH is feared for its high recurrence rate (between 9 and 27%) that mostly occurs within 3 months of the initial operation.
The optimal follow-up course for operated patients remains controversial. Due to the high rate of recurrences, one strategy is to perform serial CT scans in order to identify recurrent hematomas early. The radiologic evidence of a recurrent or significant persistent hematoma often leads to reoperation. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of persistent or new neurologic deficits. Advocators of this strategy argue that follow up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.
However, even when neuroimaging is done routinely, no correlation has been observed between the radiologic evidence of a hematoma remnant and the reoperation rate. This observation has been reported by Mori and Maeda in a retrospective analysis of 500 patients. Some persistent hematoma is almost always seen after the surgical intervention and there seems to be a correlation between the re-expansion rate of the brain and the likelihood of hematoma recurrence. However, the correlation is weak and of little practical value for patient treatment. The high incidence of hematoma remnants in post-op imaging complicates the indication for re-operation of a recurrent CSH solely by imaging criteria. Since the presence and the amount of remnant hematoma after the operation is a poor predictor of future recurrent hematoma some clinicians refrain from postoperative CT scans and rely solely on neurological assessments. If patients become symptomatic, serial CT scans are performed and surgery is scheduled in cases of persistent, enlarging or new hematoma. The discrepancy in follow-up strategy reflects our current incomplete understanding of the pathophysiology of CSH and its recurrence.
The aim of the current study is to evaluate the role of CT scanning in the postoperative treatment course after neurosurgical evacuation of CSH in a prospective, randomized controlled trial.
Objective
The hypothesis of interest to test in this trial is that a follow-up protocol without any CT scan is not inferior to a follow-up protocol with serial CT scans after neurosurgical evacuation of CSH as assessed with the modified Rankin scale at 6 months. Additional hypotheses of interest are that the size/volume/features of the hematoma rest/remnant in an early (<72 hours) CT scan after neurosurgical evacuation is not correlated to the neurological status of the patient and that the size/volume/features of the hematoma rest/remnant on post-op CT scans is not predictive for reoperation.
Methods
Patients will be screened and included into this study within 48 hours after surgery for a chronic subdural hematoma (burr hole trepanation and insertion of drainage). Study patients are randomized (1:1) on day 2 after surgery into CT-Scan arm (group A) or Clinical arm (group B). A CT scan is scheduled for patients of group A on day 2 and 30 after surgery. Patients of both study groups (A and B) will receive a neurological follow-up examination at day 2, 30 days and 6 months after surgery. Regardless of randomization all patients will receive CT scanning if judged necessary on clinical grounds at any time.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- cranial CT scan
- Keywords
- chronic subdural hematoma, burr hole trepanation, radiologic follow-up, outcome, recurrence
- Medical subject headings
- Hematoma, Subdural, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranial CT scanOther
Patients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30. Receives: Other: cranial CT scan |
| 2 | No intervention | Patients in this study arm will undergo neurological evaluation on day 2 and day 30 without follow-up CT scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
Measured: 6 months
Secondary outcomes (6)
Rate of reoperation
Measured: 6 months
Mini Mental Status
Measured: 6 months
NIHSS
Measured: 6 months
QLQ-C30
Measured: 6 months
Total length of hospitalisation
Measured: 6 months
Influence of the size and radiological features of the hematoma on rate of recurrence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study start1 Jun 2012
- Primary completion6 Feb 2017
- Study completion6 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe E Schucht, MD, Principal investigator, Inselspital Bern, University Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624545
- Sponsor's protocol ID
- 218/10
- Other IDs
- 2179
- Acronym
- TOSCAN
- Status last verified
- Feb 2017
- First submitted
- 18 Jun 2012
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mori K, Maeda M. Surgical treatment of chronic subdural hematoma in 500 consecutive cases: clinical characteristics, surgical outcome, complications, and recurrence rate. Neurol Med Chir (Tokyo). 2001 Aug;41(8):371-81. doi: 10.2176/nmc.41.371.
PubMed 11561347Torihashi K, Sadamasa N, Yoshida K, Narumi O, Chin M, Yamagata S. Independent predictors for recurrence of chronic subdural hematoma: a review of 343 consecutive surgical cases. Neurosurgery. 2008 Dec;63(6):1125-9; discussion 1129. doi: 10.1227/01.NEU.0000335782.60059.17.
PubMed 19008766Forster MT, Mathe AK, Senft C, Scharrer I, Seifert V, Gerlach R. The influence of preoperative anticoagulation on outcome and quality of life after surgical treatment of chronic subdural hematoma. J Clin Neurosci. 2010 Aug;17(8):975-9. doi: 10.1016/j.jocn.2009.11.023. Epub 2010 May 23.
PubMed 20580997Abouzari M, Rashidi A, Rezaii J, Esfandiari K, Asadollahi M, Aleali H, Abdollahzadeh M. The role of postoperative patient posture in the recurrence of traumatic chronic subdural hematoma after burr-hole surgery. Neurosurgery. 2007 Oct;61(4):794-7; discussion 797. doi: 10.1227/01.NEU.0000298908.94129.67.
PubMed 17986941Oishi M, Toyama M, Tamatani S, Kitazawa T, Saito M. Clinical factors of recurrent chronic subdural hematoma. Neurol Med Chir (Tokyo). 2001 Aug;41(8):382-6. doi: 10.2176/nmc.41.382.
PubMed 11561348Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
PubMed 19782872Lee HY, Ju YM, Lee MH, Lee SJ, Chang WH, Imm CW. A case of post-traumatic coronary occlusion. Korean J Intern Med. 1991 Jan;6(1):33-7. doi: 10.3904/kjim.1991.6.1.33.
PubMed 1742254
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Scan or Not to Scan: The Role of Follow-up CT Scanning for Management of Chronic Subdural Hematoma After Neurosurgical Evacuation - a Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01624545
- Acronym / sponsor ID
- TOSCAN / 218/10
- Conditions
- Chronic Subdural Hematoma
- Keywords
- chronic subdural hematoma, burr hole trepanation, radiologic follow-up, outcome, recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 6 Feb 2017 (actual)
- First posted
- 20 Jun 2012 (estimated)
- 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.
Chronic subdural hematoma (CSH) is one of the most common bleedings of the head. These hematomas develop after minor head trauma and increase in size over weeks. Patients usually present with headaches, gait disturbances, language problems or confusion. The state of the art treatment of a symptomatic chronic subdural hematoma is to remove the hematoma by burr hole trepanation.
The optimal follow-up for operated patients remains controversial. Due to the known high rate of a second hematoma at the same place (usually within weeks), one strategy is to perform serial computer tomography scans in order to identify recurrent hematomas early. The radiologic evidence of a second hematoma often leads to reoperation, even if the patient has no, or just slight symptoms. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of new symptoms. Advocators of this strategy argue that a follow-up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.
The aim of the current study is to evaluate the role of computer tomography scanning in the postoperative follow-up after removal of a chronic subdural hematoma. Participants of this study will be allocated by chance to one of two study groups: Patients allocated to group A will receive a computer tomography scan on day 2 and again on day 30 after surgery in addition to a clinical examination. Patients allocated to group B will be examined clinically on day 2 and day 30 without computer tomography. All patients will undergo a final clinical examination after 6 months. The study will recruit 400 patients.
Detailed description
Background
Chronic subdural hematoma (CSH) is one of the most common intracranial bleedings in patients over 60 years of age and a frequently found neurosurgical entity. Age related brain atrophy leads to enlargement of the subarachnoid space, a space limited by the dura mater and the arachnoid membrane. Blood vessels that occupy this space are being stretched and may rupture after a minor head trauma. Although the resulting bleeding itself is often without noticeable consequence for the patient, the anatomical outcome may be serious as it enlarges the subdural space. The formation of new leaky capillary-like vessels and/or volume enhancing osmotic gradients lead to the enlargement of the subdural hematoma over weeks, filling the intracranial space and compressing the brain. Headaches, gait disturbances, language problems, hemiparesis and decreased consciousness are among the many presenting symptoms and tend to develop over days or weeks.
Computed tomography (CT) scan or magnetic resonance imaging (MRI) of the head typically reveals the blood accumulation in the subdural space. Standard treatment includes the evacuation of the subdural blood through burr holes (see below) under either local or general anesthesia. In cases when a hematoma clot cannot be evacuated through burr holes a small craniotomy is performed. CSH is feared for its high recurrence rate (between 9 and 27%) that mostly occurs within 3 months of the initial operation.
The optimal follow-up course for operated patients remains controversial. Due to the high rate of recurrences, one strategy is to perform serial CT scans in order to identify recurrent hematomas early. The radiologic evidence of a recurrent or significant persistent hematoma often leads to reoperation. Another strategy after surgical hematoma evacuation is to closely follow the patient with neurological examinations and perform neuroimaging only in case of persistent or new neurologic deficits. Advocators of this strategy argue that follow up with routine CT scans may be harmful due to additional and maybe unnecessary surgeries and hospital days in a patient population marked by advanced age and fragility.
However, even when neuroimaging is done routinely, no correlation has been observed between the radiologic evidence of a hematoma remnant and the reoperation rate. This observation has been reported by Mori and Maeda in a retrospective analysis of 500 patients. Some persistent hematoma is almost always seen after the surgical intervention and there seems to be a correlation between the re-expansion rate of the brain and the likelihood of hematoma recurrence. However, the correlation is weak and of little practical value for patient treatment. The high incidence of hematoma remnants in post-op imaging complicates the indication for re-operation of a recurrent CSH solely by imaging criteria. Since the presence and the amount of remnant hematoma after the operation is a poor predictor of future recurrent hematoma some clinicians refrain from postoperative CT scans and rely solely on neurological assessments. If patients become symptomatic, serial CT scans are performed and surgery is scheduled in cases of persistent, enlarging or new hematoma. The discrepancy in follow-up strategy reflects our current incomplete understanding of the pathophysiology of CSH and its recurrence.
The aim of the current study is to evaluate the role of CT scanning in the postoperative treatment course after neurosurgical evacuation of CSH in a prospective, randomized controlled trial.
Objective
The hypothesis of interest to test in this trial is that a follow-up protocol without any CT scan is not inferior to a follow-up protocol with serial CT scans after neurosurgical evacuation of CSH as assessed with the modified Rankin scale at 6 months. Additional hypotheses of interest are that the size/volume/features of the hematoma rest/remnant in an early (<72 hours) CT scan after neurosurgical evacuation is not correlated to the neurological status of the patient and that the size/volume/features of the hematoma rest/remnant on post-op CT scans is not predictive for reoperation.
Methods
Patients will be screened and included into this study within 48 hours after surgery for a chronic subdural hematoma (burr hole trepanation and insertion of drainage). Study patients are randomized (1:1) on day 2 after surgery into CT-Scan arm (group A) or Clinical arm (group B). A CT scan is scheduled for patients of group A on day 2 and 30 after surgery. Patients of both study groups (A and B) will receive a neurological follow-up examination at day 2, 30 days and 6 months after surgery. Regardless of randomization all patients will receive CT scanning if judged necessary on clinical grounds at any time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: cranial CT scanPatients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30. |
| 2 | No intervention | –Patients in this study arm will undergo neurological evaluation on day 2 and day 30 without follow-up CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours
- Age 18 years or older
- Written informed consent from the patient to participate in the study
Key exclusion criteria (6 listed)
- Moribund state of health prohibiting surgery
- Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad)
- Recurrent hematoma if the first surgery was performed before study start
- CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa
- Pregnancy
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 |
|---|---|---|
| cranial CT scanPatients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30. | Other | 1 |
Primary outcome
modified Rankin Scale
Time frame: 6 months
6 secondary outcomes
Rate of reoperation
Time frame: 6 months
Mini Mental Status
Time frame: 6 months
NIHSS
Time frame: 6 months
QLQ-C30
Time frame: 6 months
Total length of hospitalisation
Time frame: 6 months
Influence of the size and radiological features of the hematoma on rate of recurrence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Background: PubMed 11561347Mori K, Maeda M. Surgical treatment of chronic subdural hematoma in 500 consecutive cases: clinical characteristics, surgical outcome, complications, and recurrence rate. Neurol Med Chir (Tokyo). 2001 Aug;41(8):371-81. doi: 10.2176/nmc.41.371.
- Background: PubMed 19008766Torihashi K, Sadamasa N, Yoshida K, Narumi O, Chin M, Yamagata S. Independent predictors for recurrence of chronic subdural hematoma: a review of 343 consecutive surgical cases. Neurosurgery. 2008 Dec;63(6):1125-9; discussion 1129. doi: 10.1227/01.NEU.0000335782.60059.17.
- Background: PubMed 20580997Forster MT, Mathe AK, Senft C, Scharrer I, Seifert V, Gerlach R. The influence of preoperative anticoagulation on outcome and quality of life after surgical treatment of chronic subdural hematoma. J Clin Neurosci. 2010 Aug;17(8):975-9. doi: 10.1016/j.jocn.2009.11.023. Epub 2010 May 23.
- Background: PubMed 17986941Abouzari M, Rashidi A, Rezaii J, Esfandiari K, Asadollahi M, Aleali H, Abdollahzadeh M. The role of postoperative patient posture in the recurrence of traumatic chronic subdural hematoma after burr-hole surgery. Neurosurgery. 2007 Oct;61(4):794-7; discussion 797. doi: 10.1227/01.NEU.0000298908.94129.67.
- Background: PubMed 11561348Oishi M, Toyama M, Tamatani S, Kitazawa T, Saito M. Clinical factors of recurrent chronic subdural hematoma. Neurol Med Chir (Tokyo). 2001 Aug;41(8):382-6. doi: 10.2176/nmc.41.382.
- Background: PubMed 19782872Santarius T, Kirkpatrick PJ, Ganesan D, Chia HL, Jalloh I, Smielewski P, Richards HK, Marcus H, Parker RA, Price SJ, Kirollos RW, Pickard JD, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067-73. doi: 10.1016/S0140-6736(09)61115-6.
- Background: PubMed 1742254Lee HY, Ju YM, Lee MH, Lee SJ, Chang WH, Imm CW. A case of post-traumatic coronary occlusion. Korean J Intern Med. 1991 Jan;6(1):33-7. doi: 10.3904/kjim.1991.6.1.33.
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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.
Philippe E Schucht, MD principal investigator
Inselspital Bern, University Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cranial CT scan in people with Chronic Subdural Hematoma, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 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: finished, as of the sponsor's last update on 13 Feb 2017. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 6 months). 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 NCT01624545, which also lists 7 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 13 Feb 2017.