Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03985176
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

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.


Condition or disease Intervention/treatment
Aneurysmal Subarachnoid Hemorrhage Device: ROTEM Procedure: EEG Procedure: bilateral compression ultrasound of the lower extremity veins

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.


Layout table for study information
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 : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
Aneurysmal SAH patients
Patients suffering from aneurysmal subarachnoid haemorrhage
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of delayed cerebral ischemia [ Time Frame: 14 days ]
    Incidence of DCI (delayed cerebral ischemia)

  2. Incidence of deep venous thrombosis [ Time Frame: Within 3-7 days ]
    Incidence of deep venous thrombosis

  3. Other rotational thromboelastometry analysis [ Time Frame: from 24 to 288 hours ]
    Maximal clot firmness of extrinsic (EXTEM) analysis (EXTEM-MCF) using rotational thromboelastometry

  4. Assessment of neurological outcome [ Time Frame: 90 days ]

    Description of the neurological outcome by using extended Glasgow Outcome Score

    1. Death
    2. Vegetative sate
    3. Lower severe disability
    4. Upper severe disability
    5. Lower moderate disability
    6. Upper moderate disability
    7. Lower good recovery
    8. Upper good recovery

  5. Assessment of pain [ Time Frame: Up to 14 days ]
    Critical Care Pain Observation Tool values, from 0: no pain to 8: maximum pain

  6. Assessment of cardiopulmonary function by transthoracic echocardiography [ Time Frame: At admission and at at 24±4 hours ]
    Function of the left and right ventricle using scale 1. hyperkinetic,2. normal, 3. moderately impaired, 4. severely impaired

  7. Continuous electroencephalography [ Time Frame: From 48 hours to 14 days ]
    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)

  8. Neuroglial brain injury biomarkers [ Time Frame: From 24 to 288 hours ]
    Peripheral blood biomarkers potentially reflecting neuroglial injury will be analysed with enzyme-linked immunosorbent assays


Biospecimen Retention:   Samples With DNA
The total amount of blood collected 109.5 ml


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from aneurysmal subarachnoid haemorrhage
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985176


Contacts
Layout table for location contacts
Contact: Anne Kuitunen, PhD +358331165544 anne.kuitunen@pshp.fi
Contact: Essi Raatikainen, MD 0331165396 essi.raatikainen@pshp.fi

Locations
Layout table for location information
Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33500
Contact: Anne Kuitunen, PhD         
Sponsors and Collaborators
Tampere University Hospital
Investigators
Layout table for investigator information
Study Chair: Simo Varila Tampere University Hospital

Layout table for additonal information
Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03985176     History of Changes
Other Study ID Numbers: R18110
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tampere University Hospital:
aneurysmal subarachnoid hemorrhage
delayed cerebral ischemia
Intensive Care Unit
Neurosurgery

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Ischemia
Subarachnoid Hemorrhage
Brain Ischemia
Cerebral Infarction
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Stroke