Aneurysmal Subarachnoid HemorrhageNCT03985176
Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Tampere University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- ROTEM, EEG and bilateral compression ultrasound of the lower extremity veins
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 62 participants
- Where
- 1 siteFinland
- Study dates
- 10 Jun 2019to 31 Dec 2025
- How long will I take part?
- 90 Days
- 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: Patients suffering from aneurysmal subarachnoid haemorrhage
Who may be able to join
- Age ≥ 18 years
- Admitted to the Tampere University Hospital ICU due to aneurysmal SAH
- Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA)
- Definite or approximated time for the onset of symptoms and delay to ICU admission no more than 24 hours
- Expected treatment time at least 120 hours in the Tampere University Hospital
Who cannot join
- Known pregnancy
- Any long-term anticoagulant or antithrombotic medication, except for low-dose aspirin (under 150 mg/day)
- Known active cancer or cirrhotic liver disease or end-stage renal disease requiring renal replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage: a Clinical Observational Trial
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.
Read the 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.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- ROTEM, EEG, bilateral compression ultrasound of the lower extremity veins
- Keywords
- aneurysmal subarachnoid hemorrhage, delayed cerebral ischemia, Intensive Care Unit, Neurosurgery
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEMDevice
ROTEM measurements 24,48, 72, 120, 192 and 288 hours from aneurysmal SAH
EEGProcedure or surgery
Continuous EEG-monitoring after aneurysm treatment until patient transferred to ward or up to 14 days after aneurysmal SAH
bilateral compression ultrasound of the lower extremity veinsProcedure or surgery
to exclude asymptomatic deep venous thrombosis once over days 3 to 7
| Study group | Role | What they receive |
|---|---|---|
| Aneurysmal SAH patients | Patients suffering from aneurysmal subarachnoid haemorrhage Receives: Device: ROTEM; Procedure: EEG; Procedure: bilateral compression ultrasound of the lower extremity veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed cerebral ischemia
Incidence of DCI (delayed cerebral ischemia)
Measured: 14 days
Secondary outcomes (8)
Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis
Maximal clot firmness of FIBTEM analysis (FIBTEM-MCF) using rotational thromboelastometry (ROTEM) assay
Measured: at 72 hours
Incidence of deep venous thrombosis
Incidence of deep venous thrombosis
Measured: Within 3-7 days
Other rotational thromboelastometry analysis
Maximal clot firmness of extrinsic (EXTEM) analysis (EXTEM-MCF) using rotational thromboelastometry
Measured: from 24 to 288 hours
Assessment of neurological outcome
Description of the neurological outcome by using extended Glasgow Outcome Score
- Death
- Vegetative sate
- Lower severe disability
- Upper severe disability
- Lower moderate disability
- Upper moderate disability
- Lower good recovery
- Upper good recovery
Measured: 90 days
Assessment of pain
Critical Care Pain Observation Tool values, from 0: no pain to 8: maximum pain
Measured: Up to 14 days
Assessment of cardiopulmonary function by transthoracic echocardiography
Function of the left and right ventricle using scale 1. hyperkinetic,2. normal, 3. moderately impaired, 4. severely impaired
Measured: At admission and at at 24±4 hours
Continuous electroencephalography
Continuous electroencephalography will be evaluated for signs that are potential surrogates of developing delayed cerebral ischemia (such as alpha-delta-ratio, focal slowing, epileptiform abnormalities, relative alpha variability)
Measured: From 48 hours to 14 days
Neuroglial brain injury biomarkers
Peripheral blood biomarkers potentially reflecting neuroglial injury will be analysed with enzyme-linked immunosorbent assays
Measured: From 24 to 288 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start10 Jun 2019
- Primary completion31 Mar 2022
- Study completion31 Dec 2025 (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 Tampere University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simo Varila, Study chair, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985176
- Sponsor's protocol ID
- R18110
- Status last verified
- Oct 2022
- First submitted
- 5 Jun 2019
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raatikainen E, Kiiski H, Kuitunen A, Junttila E, Huhtala H, Kallonen A, Ala-Peijari M, Langsjo J, Saukkonen J, Valo T, Kauppila T, Raerinne S, Frosen J, Vahtera A. Increased blood coagulation is associated with poor neurological outcome in aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2024 Mar 15;458:122943. doi: 10.1016/j.jns.2024.122943. Epub 2024 Feb 23.
PubMed 38422781
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage: a Clinical Observational Trial
- ClinicalTrials.gov ID
- NCT03985176
- Acronym / sponsor ID
- R18110
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- aneurysmal subarachnoid hemorrhage, delayed cerebral ischemia, Intensive Care Unit, Neurosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jun 2019 (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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aneurysmal SAH patients | – | Device: ROTEM, Procedure: EEG, Procedure: bilateral compression ultrasound of the lower extremity veinsPatients suffering from aneurysmal subarachnoid haemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from aneurysmal subarachnoid haemorrhage
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Admitted to the Tampere University Hospital ICU due to aneurysmal SAH
- Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA)
- Definite or approximated time for the onset of symptoms and delay to ICU admission no more than 24 hours
- Expected treatment time at least 120 hours in the Tampere University Hospital
Key exclusion criteria (3 listed)
- Known pregnancy
- Any long-term anticoagulant or antithrombotic medication, except for low-dose aspirin (under 150 mg/day)
- Known active cancer or cirrhotic liver disease or end-stage renal disease requiring renal replacement therapy
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 |
|---|---|---|
| ROTEMROTEM measurements 24,48, 72, 120, 192 and 288 hours from aneurysmal SAH | Device | Aneurysmal SAH patients |
| EEGContinuous EEG-monitoring after aneurysm treatment until patient transferred to ward or up to 14 days after aneurysmal SAH | Procedure or surgery | Aneurysmal SAH patients |
| bilateral compression ultrasound of the lower extremity veinsto exclude asymptomatic deep venous thrombosis once over days 3 to 7 | Procedure or surgery | Aneurysmal SAH patients |
Primary outcome
Incidence of delayed cerebral ischemia
Time frame: 14 days
Incidence of DCI (delayed cerebral ischemia)
8 secondary outcomes
Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis
Time frame: at 72 hours
Incidence of deep venous thrombosis
Time frame: Within 3-7 days
Other rotational thromboelastometry analysis
Time frame: from 24 to 288 hours
Assessment of neurological outcome
Time frame: 90 days
Assessment of pain
Time frame: Up to 14 days
Assessment of cardiopulmonary function by transthoracic echocardiography
Time frame: At admission and at at 24±4 hours
Continuous electroencephalography
Time frame: From 48 hours to 14 days
Neuroglial brain injury biomarkers
Time frame: From 24 to 288 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 38422781Raatikainen E, Kiiski H, Kuitunen A, Junttila E, Huhtala H, Kallonen A, Ala-Peijari M, Langsjo J, Saukkonen J, Valo T, Kauppila T, Raerinne S, Frosen J, Vahtera A. Increased blood coagulation is associated with poor neurological outcome in aneurysmal subarachnoid hemorrhage. J Neurol Sci. 2024 Mar 15;458:122943. doi: 10.1016/j.jns.2024.122943. Epub 2024 Feb 23.
- 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.
Simo Varila study chair
Tampere University Hospital
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 Aneurysmal Subarachnoid Hemorrhage, run by Tampere University Hospital at 1 site in Finland.
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 3 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 Nov 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 Finland. 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?
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?
Incidence of delayed cerebral ischemia (time frame: 14 days). 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 NCT03985176, 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 Nov 2022.