NCT03985176

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

June 10, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 10, 2022

Status Verified

October 1, 2022

Enrollment Period

2.8 years

First QC Date

June 5, 2019

Last Update Submit

November 7, 2022

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

aneurysmal subarachnoid hemorrhagedelayed cerebral ischemiaIntensive Care UnitNeurosurgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of delayed cerebral ischemia

    Incidence of DCI (delayed cerebral ischemia)

    14 days

Secondary Outcomes (8)

  • Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis

    at 72 hours

  • Incidence of deep venous thrombosis

    Within 3-7 days

  • Other rotational thromboelastometry analysis

    from 24 to 288 hours

  • Assessment of neurological outcome

    90 days

  • Assessment of pain

    Up to 14 days

  • +3 more secondary outcomes

Study Arms (1)

Aneurysmal SAH patients

Patients suffering from aneurysmal subarachnoid haemorrhage

Device: ROTEMProcedure: EEGProcedure: bilateral compression ultrasound of the lower extremity veins

Interventions

ROTEMDEVICE

ROTEM measurements 24,48, 72, 120, 192 and 288 hours from aneurysmal SAH

Aneurysmal SAH patients
EEGPROCEDURE

Continuous EEG-monitoring after aneurysm treatment until patient transferred to ward or up to 14 days after aneurysmal SAH

Aneurysmal SAH patients
bilateral compression ultrasound of the lower extremity veinsPROCEDURE

to exclude asymptomatic deep venous thrombosis once over days 3 to 7

Aneurysmal SAH patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffering from aneurysmal subarachnoid haemorrhage

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33500, Finland

Location

Related Publications (1)

  • 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.

    PMID: 38422781DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The total amount of blood collected 109.5 ml

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Simo Varila

    Tampere University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 13, 2019

Study Start

June 10, 2019

Primary Completion

March 31, 2022

Study Completion

December 31, 2025

Last Updated

November 10, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)