Subarachnoid Hemorrhage, AneurysmalBA&UKNCT04792944
Brain Aneurysms: Utility of Cisternal Urokinase Irrigation
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Vasospasm, Cerebral, run by University of Valencia at 1 site in Spain.
Trial summary
Despite the efforts made in its treatment, aneurysmal subarachnoid haemorrhage continues to induce high mortality and morbidity rates. Today there are treatment protocols in all hospitals. The vast majority prefer, whenever possible, the endovascular route, given its lesser aggressiveness and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal, Vasospasm, Cerebral, Hydrocephalus
- What is being tested?
- Urokinase, Endovascular treatment and Clipping
- Type of treatment
- Surgery or procedure
- How many people
- 247 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2007to 31 Dec 2020
- Phase
- Observational
- 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
Study population: This is a retrospective study of all brain aneurysms treated in our Hospital since 2007
Who may be able to join
- >18 years of age
- harbour one or more saccular brain aneurysms
- with or without subarachnoid hemorrhage (SAH)
- multiple aneurysms
Who cannot join
- absence of brain fusiform, traumatic or mycotic aneurysms
- SAH due to other causes (trauma, anticoagulation, antiplatelet medication, arteriovenous malformation, or tumor)
- any medical, neurological, or psychiatric condition that would impair patient's evaluation
- past medical history of bleeding disorders or liver diseases altering the coagulation
- anticoagulation
- platelet count <10x109/L
- prothrombin time >15 seconds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Aneurysms: a Retrospective Study on the Experience in Our Hospital With a Comparative Analysis Between the Different Techniques Used in Its Treatment
Despite the efforts made in its treatment, aneurysmal subarachnoid haemorrhage continues to induce high mortality and morbidity rates. Today there are treatment protocols in all hospitals. The vast majority prefer, whenever possible, the endovascular route, given its lesser aggressiveness and morbidity.
Although embolization prevents aneurysm' rebleeding, it does remove the subarachnoid blood clot. Therefore, it does not modify the evolution, incidence and severity of vasospasm.
The idea is to carry out a 10-year retrospective study classifying patients into five groups based on the type of treatment received, analyzing the results' differences. The aim is to improve what is done as much as possible and to be able to propose potential areas for improvement. Besides, this study will be the basis of a future prospective study, prepared without the current one's biases and errors.
Read the detailed description
Aneurysmal subarachnoid hemorrhage continues to have very high morbidity and mortality rates, despite the years elapsed and repeated attempts to reduce it.
Stabilizing the aneurysm by embolization or surgical clipping leaves unresolved the vasospasm, responsible for ischemic brain damage, causing neurological sequelae and cognitive impairment.
It has long been known that the deoxyhemoglobin liberated from the extravasated red blood cells retained in the subarachnoid clot is the leading cause of vasospasm. Different routes have been tried to minimize its deleterious effects, such as copious lavage of the skull base cisterns, lysing the subarachnoid clot with urokinase or rtPA, administration of vitamin C, iron chelators, or superoxydodismutase-like drugs.
The volume of subarachnoid hemorrhage was soon correlated with the vasospasm severity. Once this fact was known in the 1980s and 1990s, cisternal lavage was used extensively during aneurysms' surgical clipping. Clots located in the subarachnoid space were lysed with urokinase or rtPA (recombinant tissue plasminogen activator), showing positive effects, particularly evident for the most severe bleeds, those with Fisher's grades of 3 or higher.
However, the introduction of embolization changed the treatment paradigm. As the craniotomy is not carried out, the cisterns are not usually washed, which controls the rebleeding but not the vasospasm. To date, we are not aware of any study that compares the effect on vasospasm of embolization versus clipping of aneurysms with lavage of the cisterns using thrombolytic agents.
In the Neurosurgery Department of our Hospital, two periods can be identified in which the treatment of brain aneurysms has been carried out differently. In the first period between 2007 and 2011, the aneurysms were primarily subjected to embolization, and only if there was no indication for endovascular treatment, surgical clipping was performed. In the second period, between 2012 and 2018, they were operated on an emergency basis with clip application and the skull base cisterns washed with urokinase. Embolization was considered if the surgical clipping was judged too risky.
The aim is to analyze these two periods and compare the mortality, morbidity, and vasospasm rates, the need for a cerebrospinal fluid diversion (temporary and definitive), and the final neurological and cognitive status for the different therapeutic approaches.
- Being tested
- Urokinase, Endovascular treatment, Clipping, External ventricular drain
- Keywords
- Aneurysm, Subarachnoid haemorrhage, Fibrinolytic Therapy, Intracisternal fibrinolysis, Cerebral vasospasm, Delayed ischemic neurological deficit
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hydrocephalus, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrokinaseDrug
Also called Aneurysm clipping plus cisternal lavage with Urokinase
Washing the subarachnoid clot induced by a subarachnoid haemorrhage aneurysmal bleeding with urokinase after aneurysm clipping
Endovascular treatmentProcedure or surgery
Aneurysm treatment through endovascular methods
ClippingProcedure or surgery
Surgical clipping of brain aneurysms
External ventricular drainProcedure or surgery
Insertion of an external ventricular drain to treat acute hydrocephalus
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Those are the patients that do not receive any treatment for the aneurysm, neither endovascular nor surgical | |
| External ventricular drain only with neither embolization nor clipping | These patients will be treated with an external ventricular drain only with neither embolization nor clipping Receives: Procedure: External ventricular drain | |
| Embolization | These patients will be treated endovascularly Receives: Procedure: Endovascular treatment | |
| Programmed surgical clipping | These patients will be treated no on an emergency basis with surgical clipping of an aneurysm that has bled Receives: Procedure: Clipping | |
| Emergency surgical clipping with cisternal urokinase administration | These patients with undergo emergency surgical clipping with cisternal urokinase administration Receives: Drug: Urokinase; Procedure: Clipping | |
| Patients with incidental brain aneurysm discovery with no SAH and programmed aneurysm clipping | This group will include patients with incidental brain aneurysm discovery with no SAH and programmed aneurysm clipping Receives: Procedure: Clipping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasospasm
Presence and severity of vasospasm
Measured: 21 days
Cerebrospinal fluid diversion
Need for temporary or definitive cerebrospinal fluid diversion
Measured: 1 year
Mortality rate
Mortality rate in each group of patients
Measured: 1 year
Outcome
Glasgow Outcome Score (GOSE) at discharge, 6 and 12 months posttreatment
Measured: 1 year
Secondary outcomes (2)
Aneurysm regrowth
Aneurysm regrowth on follow-up after each tipe of treatment
Measured: 10 years
Aneurysm rebleed
Aneurysm rebleed on follow-up after each tipe of treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Jan 2007
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa V Moratal, Nurse, Study chair, Hospital General Universitario Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792944
- Sponsor's protocol ID
- CEIm 17-07-2019
- Acronym
- BA&UK
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Mufti F, Amuluru K, Damodara N, El-Ghanem M, Nuoman R, Kamal N, Al-Marsoummi S, Morris NA, Dangayach NS, Mayer SA. Novel management strategies for medically-refractory vasospasm following aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2018 Jul 15;390:44-51. doi: 10.1016/j.jns.2018.02.039. Epub 2018 Feb 23.
PubMed 29801906Arakawa Y, Kikuta K, Hojo M, Goto Y, Yamagata S, Nozaki K, Hashimoto N. Milrinone reduces cerebral vasospasm after subarachnoid hemorrhage of WFNS grade IV or V. Neurol Med Chir (Tokyo). 2004 Aug;44(8):393-400; discussion 401. doi: 10.2176/nmc.44.393.
PubMed 15508346Arthur AS, Fergus AH, Lanzino G, Mathys J, Kassell NF, Lee KS. Systemic administration of the iron chelator deferiprone attenuates subarachnoid hemorrhage-induced cerebral vasospasm in the rabbit. Neurosurgery. 1997 Dec;41(6):1385-91; discussion 1391-2. doi: 10.1097/00006123-199712000-00028.
PubMed 9402590Asano T. Oxyhemoglobin as the principal cause of cerebral vasospasm: a holistic view of its actions. Crit Rev Neurosurg. 1999 Sep 24;9(5):303-318. doi: 10.1007/s003290050147.
PubMed 10525849Ayer RE, Zhang JH. Oxidative stress in subarachnoid haemorrhage: significance in acute brain injury and vasospasm. Acta Neurochir Suppl. 2008;104:33-41. doi: 10.1007/978-3-211-75718-5_7.
PubMed 18456995Barbosa MD, Arthur AS, Louis RH, MacDonald T, Polin RS, Gazak C, Kassell NF. The novel 5-lipoxygenase inhibitor ABT-761 attenuates cerebral vasospasm in a rabbit model of subarachnoid hemorrhage. Neurosurgery. 2001 Nov;49(5):1205-12; discussion 1212-3. doi: 10.1097/00006123-200111000-00032.
PubMed 11846914Bilginer B, Onal MB, Narin F, Soylemezoglu F, Ziyal IM, Ozgen T. The effects of intravenous cilostazol and nimodipine on cerebral vasospasm after subarachnoid hemorrhage in an experimental rabbit model. Turk Neurosurg. 2009 Oct;19(4):374-9.
PubMed 19847758Dalbayrak S, Altas M, Arslan R. The effects of timing of aneurysm surgery on vasospasm and mortality in patients with subarachnoid hemorrhage. Acta Neurol Belg. 2011 Dec;111(4):317-20.
PubMed 22368972Ding X, Wang ZG, Wang CW, Wang YH. [Timing of treatment on the prognosis of poor-grade aneurysmal subarachnoid hemorrhage patients]. Zhonghua Yi Xue Za Zhi. 2012 Dec 4;92(45):3211-4. Chinese.
PubMed 23328469Dorhout Mees SM, Molyneux AJ, Kerr RS, Algra A, Rinkel GJ. Timing of aneurysm treatment after subarachnoid hemorrhage: relationship with delayed cerebral ischemia and poor outcome. Stroke. 2012 Aug;43(8):2126-9. doi: 10.1161/STROKEAHA.111.639690. Epub 2012 Jun 14.
PubMed 22700527Findlay JM. A randomized trial of intraoperative, intracisternal tissue plasminogen activator for the prevention of vasospasm. Neurosurgery. 1995 Nov;37(5):1026-7. doi: 10.1227/00006123-199511000-00031. No abstract available.
PubMed 8559330Gorski R, Zabek M, Jarmuzek P. Influence of intraoperative using of recombinant tissue plasminogen activator on the development of cerebral angiospasm after subarachnoid haemorrhage in patients with ruptured intracranial aneurysms. Neurol Neurochir Pol. 2000;34(6 Suppl):41-7.
PubMed 11452854Hamada J, Mizuno T, Kai Y, Morioka M, Ushio Y. Microcatheter intrathecal urokinase infusion into cisterna magna for prevention of cerebral vasospasm: preliminary report. Stroke. 2000 Sep;31(9):2141-8. doi: 10.1161/01.str.31.9.2141.
PubMed 10978043Handa Y, Kaneko M, Takeuchi H, Tsuchida A, Kobayashi H, Kubota T. Effect of an antioxidant, ebselen, on development of chronic cerebral vasospasm after subarachnoid hemorrhage in primates. Surg Neurol. 2000 Apr;53(4):323-9. doi: 10.1016/s0090-3019(00)00168-3.
PubMed 10825515Hanggi D, Steiger HJ. The influence of cisternal and ventricular lavage on cerebral vasospasm in patients suffering from subarachnoid hemorrhage: analysis of effectiveness. Acta Neurochir Suppl. 2011;110(Pt 2):95-8. doi: 10.1007/978-3-7091-0356-2_17.
PubMed 21125452
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Aneurysms: a Retrospective Study on the Experience in Our Hospital With a Comparative Analysis Between the Different Techniques Used in Its Treatment
- ClinicalTrials.gov ID
- NCT04792944
- Acronym / sponsor ID
- BA&UK / CEIm 17-07-2019
- Keywords
- Aneurysm, Subarachnoid haemorrhage, Fibrinolytic Therapy, Intracisternal fibrinolysis, Cerebral vasospasm, Delayed ischemic neurological deficit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Mar 2021 (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.
Despite the efforts made in its treatment, aneurysmal subarachnoid haemorrhage continues to induce high mortality and morbidity rates. Today there are treatment protocols in all hospitals. The vast majority prefer, whenever possible, the endovascular route, given its lesser aggressiveness and morbidity.
Although embolization prevents aneurysm' rebleeding, it does remove the subarachnoid blood clot. Therefore, it does not modify the evolution, incidence and severity of vasospasm.
The idea is to carry out a 10-year retrospective study classifying patients into five groups based on the type of treatment received, analyzing the results' differences. The aim is to improve what is done as much as possible and to be able to propose potential areas for improvement. Besides, this study will be the basis of a future prospective study, prepared without the current one's biases and errors.
Detailed description
Aneurysmal subarachnoid hemorrhage continues to have very high morbidity and mortality rates, despite the years elapsed and repeated attempts to reduce it.
Stabilizing the aneurysm by embolization or surgical clipping leaves unresolved the vasospasm, responsible for ischemic brain damage, causing neurological sequelae and cognitive impairment.
It has long been known that the deoxyhemoglobin liberated from the extravasated red blood cells retained in the subarachnoid clot is the leading cause of vasospasm. Different routes have been tried to minimize its deleterious effects, such as copious lavage of the skull base cisterns, lysing the subarachnoid clot with urokinase or rtPA, administration of vitamin C, iron chelators, or superoxydodismutase-like drugs.
The volume of subarachnoid hemorrhage was soon correlated with the vasospasm severity. Once this fact was known in the 1980s and 1990s, cisternal lavage was used extensively during aneurysms' surgical clipping. Clots located in the subarachnoid space were lysed with urokinase or rtPA (recombinant tissue plasminogen activator), showing positive effects, particularly evident for the most severe bleeds, those with Fisher's grades of 3 or higher.
However, the introduction of embolization changed the treatment paradigm. As the craniotomy is not carried out, the cisterns are not usually washed, which controls the rebleeding but not the vasospasm. To date, we are not aware of any study that compares the effect on vasospasm of embolization versus clipping of aneurysms with lavage of the cisterns using thrombolytic agents.
In the Neurosurgery Department of our Hospital, two periods can be identified in which the treatment of brain aneurysms has been carried out differently. In the first period between 2007 and 2011, the aneurysms were primarily subjected to embolization, and only if there was no indication for endovascular treatment, surgical clipping was performed. In the second period, between 2012 and 2018, they were operated on an emergency basis with clip application and the skull base cisterns washed with urokinase. Embolization was considered if the surgical clipping was judged too risky.
The aim is to analyze these two periods and compare the mortality, morbidity, and vasospasm rates, the need for a cerebrospinal fluid diversion (temporary and definitive), and the final neurological and cognitive status for the different therapeutic approaches.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | –Those are the patients that do not receive any treatment for the aneurysm, neither endovascular nor surgical |
| External ventricular drain only with neither embolization nor clipping | – | Procedure: External ventricular drainThese patients will be treated with an external ventricular drain only with neither embolization nor clipping |
| Embolization | – | Procedure: Endovascular treatmentThese patients will be treated endovascularly |
| Programmed surgical clipping | – | Procedure: ClippingThese patients will be treated no on an emergency basis with surgical clipping of an aneurysm that has bled |
| Emergency surgical clipping with cisternal urokinase administration | – | Drug: Urokinase, Procedure: ClippingThese patients with undergo emergency surgical clipping with cisternal urokinase administration |
| Patients with incidental brain aneurysm discovery with no SAH and programmed aneurysm clipping | – | Procedure: ClippingThis group will include patients with incidental brain aneurysm discovery with no SAH and programmed aneurysm clipping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective study of all brain aneurysms treated in our Hospital since 2007
Key inclusion criteria (4 listed)
- >18 years of age
- harbour one or more saccular brain aneurysms
- with or without subarachnoid hemorrhage (SAH)
- multiple aneurysms
Key exclusion criteria (7 listed)
- absence of brain fusiform, traumatic or mycotic aneurysms
- SAH due to other causes (trauma, anticoagulation, antiplatelet medication, arteriovenous malformation, or tumor)
- any medical, neurological, or psychiatric condition that would impair patient's evaluation
- past medical history of bleeding disorders or liver diseases altering the coagulation
- anticoagulation
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 |
|---|---|---|
| UrokinaseAlso: Aneurysm clipping plus cisternal lavage with UrokinaseWashing the subarachnoid clot induced by a subarachnoid haemorrhage aneurysmal bleeding with urokinase after aneurysm clipping | Drug | Emergency surgical clipping with cisternal urokinase administration |
| Endovascular treatmentAneurysm treatment through endovascular methods | Procedure or surgery | Embolization |
| ClippingSurgical clipping of brain aneurysms | Procedure or surgery | Emergency surgical clipping with cisternal urokinase administration, Patients with incidental brain aneurysm discovery with no SAH and programmed aneurysm clipping, Programmed surgical clipping |
| External ventricular drainInsertion of an external ventricular drain to treat acute hydrocephalus | Procedure or surgery | External ventricular drain only with neither embolization nor clipping |
Primary outcome
Vasospasm
Time frame: 21 days
Presence and severity of vasospasm
Cerebrospinal fluid diversion
Time frame: 1 year
Need for temporary or definitive cerebrospinal fluid diversion
Mortality rate
Time frame: 1 year
Mortality rate in each group of patients
Outcome
Time frame: 1 year
Glasgow Outcome Score (GOSE) at discharge, 6 and 12 months posttreatment
2 secondary outcomes
Aneurysm regrowth
Time frame: 10 years
Aneurysm rebleed
Time frame: 10 years
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 11 Mar 2021.
- Results publication: PubMed 29801906Al-Mufti F, Amuluru K, Damodara N, El-Ghanem M, Nuoman R, Kamal N, Al-Marsoummi S, Morris NA, Dangayach NS, Mayer SA. Novel management strategies for medically-refractory vasospasm following aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2018 Jul 15;390:44-51. doi: 10.1016/j.jns.2018.02.039. Epub 2018 Feb 23.
- Results publication: PubMed 15508346Arakawa Y, Kikuta K, Hojo M, Goto Y, Yamagata S, Nozaki K, Hashimoto N. Milrinone reduces cerebral vasospasm after subarachnoid hemorrhage of WFNS grade IV or V. Neurol Med Chir (Tokyo). 2004 Aug;44(8):393-400; discussion 401. doi: 10.2176/nmc.44.393.
- Results publication: PubMed 9402590Arthur AS, Fergus AH, Lanzino G, Mathys J, Kassell NF, Lee KS. Systemic administration of the iron chelator deferiprone attenuates subarachnoid hemorrhage-induced cerebral vasospasm in the rabbit. Neurosurgery. 1997 Dec;41(6):1385-91; discussion 1391-2. doi: 10.1097/00006123-199712000-00028.
- Results publication: PubMed 10525849Asano T. Oxyhemoglobin as the principal cause of cerebral vasospasm: a holistic view of its actions. Crit Rev Neurosurg. 1999 Sep 24;9(5):303-318. doi: 10.1007/s003290050147.
- Results publication: PubMed 18456995Ayer RE, Zhang JH. Oxidative stress in subarachnoid haemorrhage: significance in acute brain injury and vasospasm. Acta Neurochir Suppl. 2008;104:33-41. doi: 10.1007/978-3-211-75718-5_7.
- Results publication: PubMed 11846914Barbosa MD, Arthur AS, Louis RH, MacDonald T, Polin RS, Gazak C, Kassell NF. The novel 5-lipoxygenase inhibitor ABT-761 attenuates cerebral vasospasm in a rabbit model of subarachnoid hemorrhage. Neurosurgery. 2001 Nov;49(5):1205-12; discussion 1212-3. doi: 10.1097/00006123-200111000-00032.
- Results publication: PubMed 19847758Bilginer B, Onal MB, Narin F, Soylemezoglu F, Ziyal IM, Ozgen T. The effects of intravenous cilostazol and nimodipine on cerebral vasospasm after subarachnoid hemorrhage in an experimental rabbit model. Turk Neurosurg. 2009 Oct;19(4):374-9.
- Results publication: PubMed 22368972Dalbayrak S, Altas M, Arslan R. The effects of timing of aneurysm surgery on vasospasm and mortality in patients with subarachnoid hemorrhage. Acta Neurol Belg. 2011 Dec;111(4):317-20.
- Results publication: PubMed 23328469Ding X, Wang ZG, Wang CW, Wang YH. [Timing of treatment on the prognosis of poor-grade aneurysmal subarachnoid hemorrhage patients]. Zhonghua Yi Xue Za Zhi. 2012 Dec 4;92(45):3211-4. Chinese.
- Results publication: PubMed 22700527Dorhout Mees SM, Molyneux AJ, Kerr RS, Algra A, Rinkel GJ. Timing of aneurysm treatment after subarachnoid hemorrhage: relationship with delayed cerebral ischemia and poor outcome. Stroke. 2012 Aug;43(8):2126-9. doi: 10.1161/STROKEAHA.111.639690. Epub 2012 Jun 14.
- Results publication: PubMed 8559330Findlay JM. A randomized trial of intraoperative, intracisternal tissue plasminogen activator for the prevention of vasospasm. Neurosurgery. 1995 Nov;37(5):1026-7. doi: 10.1227/00006123-199511000-00031. No abstract available.
- Results publication: PubMed 11452854Gorski R, Zabek M, Jarmuzek P. Influence of intraoperative using of recombinant tissue plasminogen activator on the development of cerebral angiospasm after subarachnoid haemorrhage in patients with ruptured intracranial aneurysms. Neurol Neurochir Pol. 2000;34(6 Suppl):41-7.
- Individual participant dataSharing planned: No
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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.
Teresa V Moratal, Nurse study chair
Hospital General Universitario Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, Aneurysmal and Vasospasm, Cerebral, run by University of Valencia at 1 site in Spain.
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 7 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 11 Mar 2021. 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 Spain. 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?
Vasospasm (time frame: 21 days). 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 NCT04792944, which also lists 25 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 11 Mar 2021.