Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI).
In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.
Condition or disease | Intervention/treatment |
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Aneurysmal Subarachnoid Hemorrhage | Device: ROTEM Procedure: EEG Procedure: bilateral compression ultrasound of the lower extremity veins |
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from a secondary injury during the first 2-3 weeks from the insult.
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI).
In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 60 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 90 Days |
Official Title: | Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage: a Clinical Observational Trial |
Actual Study Start Date : | June 10, 2019 |
Estimated Primary Completion Date : | December 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Group/Cohort | Intervention/treatment |
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Aneurysmal SAH patients
Patients suffering from aneurysmal subarachnoid haemorrhage
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Device: ROTEM
ROTEM measurements 24,48, 72, 120, 192 and 288 hours from aneurysmal SAH
Procedure: EEG Continuous EEG-monitoring after aneurysm treatment until patient transferred to ward or up to 14 days after aneurysmal SAH
Procedure: bilateral compression ultrasound of the lower extremity veins to exclude asymptomatic deep venous thrombosis once over days 3 to 7
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Description of the neurological outcome by using extended Glasgow Outcome Score
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Anne Kuitunen, PhD | +358331165544 | anne.kuitunen@pshp.fi | |
Contact: Essi Raatikainen, MD | 0331165396 | essi.raatikainen@pshp.fi |
Finland | |
Tampere University Hospital | Recruiting |
Tampere, Finland, 33500 | |
Contact: Anne Kuitunen, PhD |
Study Chair: | Simo Varila | Tampere University Hospital |
Tracking Information | |||||||||
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First Submitted Date | June 5, 2019 | ||||||||
First Posted Date | June 13, 2019 | ||||||||
Last Update Posted Date | April 15, 2021 | ||||||||
Actual Study Start Date | June 10, 2019 | ||||||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Incidence of delayed cerebral ischemia [ Time Frame: 14 days ] Incidence of DCI (delayed cerebral ischemia)
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Original Primary Outcome Measures |
Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis [ Time Frame: at 72 hours ] Maximal clot firmness of FIBTEM analysis (FIBTEM-MCF) using rotational thromboelastometry (ROTEM) assay
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Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage | ||||||||
Official Title | Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage: a Clinical Observational Trial | ||||||||
Brief Summary |
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI). In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI. |
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Detailed Description |
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from a secondary injury during the first 2-3 weeks from the insult. Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI). In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI. |
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Study Type | Observational [Patient Registry] | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 90 Days | ||||||||
Biospecimen | Retention: Samples With DNA Description:
The total amount of blood collected 109.5 ml
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Sampling Method | Probability Sample | ||||||||
Study Population | Patients suffering from aneurysmal subarachnoid haemorrhage | ||||||||
Condition | Aneurysmal Subarachnoid Hemorrhage | ||||||||
Intervention |
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Study Groups/Cohorts | Aneurysmal SAH patients
Patients suffering from aneurysmal subarachnoid haemorrhage
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
60 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 31, 2022 | ||||||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Finland | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03985176 | ||||||||
Other Study ID Numbers | R18110 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Tampere University Hospital | ||||||||
Study Sponsor | Tampere University Hospital | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Tampere University Hospital | ||||||||
Verification Date | April 2021 |