Delayed Cerebral Ischaemia and Coagulation Alterations Af... | NCT03985176

Studies
Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage

NCT03985176

Sponsor

Tampere University Hospital

Status

Unknown status

Last Update Posted

Nov 10, 2022Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Aneurysmal Subarachnoid Hemorrhage

Interventions

ROTEM
EEG
bilateral compression ultrasound of the lower extremity veins

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2019Actual

Primary Completion Date

Mar 31, 2022Actual

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jun 5, 2019

First Submission Date that Met QC Criteria

Jun 12, 2019

First Posted Date

Jun 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2022

Last Update Posted Date

Nov 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

90 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aneurysmal SAH patients		Patients suffering from aneurysmal subarachnoid haemorrhage	Device: ROTEM Procedure: EEG Procedure: bilateral compression ultrasound of the lower extremity veins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ROTEM	Device	ROTEM measurements 24,48, 72, 120, 192 and 288 hours from aneurysmal SAH	Aneurysmal SAH patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of delayed cerebral ischemia	Incidence of DCI (delayed cerebral ischemia)	14 days

Secondary Outcomes

Measure	Description	Time Frame
Maximal clot firmness of FIBTEM (FIBTEM-MCF) analysis	Maximal clot firmness of FIBTEM analysis (FIBTEM-MCF) using rotational thromboelastometry (ROTEM) assay	at 72 hours
Incidence of deep venous thrombosis

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from aneurysmal subarachnoid haemorrhage

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simo Varila	Tampere University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tampere University Hospital		Tampere		33500	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38422781	Derived	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.

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases