NCT02320539

Brief Summary

The purpose of this study is to validate results from a related trial (NCT01791257) and to compare the profile of microRNA in blood from patients suffering subarachnoid hemorrhage with and without systemic complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 28, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

October 28, 2014

Last Update Submit

May 25, 2015

Conditions

Subarachnoid HemorrhageDelayed Cerebral IschemiaAcute Lung InjuryCardiac DysfunctionSystemic Inflammatory Response Syndrome

Keywords

MicroRNACerebrospinal fluid

Outcome Measures

Primary Outcomes (3)

  • Delayed Cerebral Ischemia

    Delayed Cerebral Ischemia as defined by Vergouwen et al\[1\]. In our earlier study we found the clinical condition DCI somehow subjective which is why we added the following two primary outcome measures. Comparing microRNA profiles between groups with or without.

    21 days

  • Delayed Cerebral Ischemia and Cerebral infarction

    as defined by Vergouwen et al \[1\]. Comparing microRNA profiles between groups with or without.

    21 days

  • Delayed Cerebral infarction

    as defined by Vergouwen et al \[1\]. Comparing microRNA profiles between groups with or without.

    21 days

Secondary Outcomes (4)

  • Acute Lung Injury

    21 days

  • Cardiac Dysfunction

    21 days

  • Systemic Inflammatory Response Syndrome

    21 days

  • Early Brain Injury

    Clinical evaluation 24-72 hours after ictus. (Wake-up call if sedated)

Study Arms (4)

SAH with DCI

After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.

SAH without DCI

After 21 days from ictus the patients with subarachnoid hemorrhage are stratified to group 1 or 2 depending on their development of delayed cerebral ischemia.

SAH good grade

SAH without external ventricular drainage

Healthy controls

Blood sample in healthy donors registered in the National Donor Registry.

Eligibility Criteria

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

Group 1-2: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated with external ventricular drain. Group 3: Patients admitted to Neurointensive Department in Rigshospitalet with SAH treated without external ventricular drain. Group 4: Healthy blood donors

You may qualify if:

  • Uncertainty \< 24 times on time of ictus
  • Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated with external ventricular drain.
  • Patients admitted to Neurointensive Department in Rigshospitalet with aneurysmal SAH treated without external ventricular drain.

You may not qualify if:

  • Transfer to other hospital within 5 days of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark, 2100, Denmark

Location

Related Publications (1)

  • Matzen JS, Krogh CL, Forman JL, Garred P, Moller K, Bache S. Lectin complement pathway initiators after subarachnoid hemorrhage - an observational study. J Neuroinflammation. 2020 Nov 12;17(1):338. doi: 10.1186/s12974-020-01979-y.

    PMID: 33183322DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

MicroRNA profiles from blood and cerebrospinal fluid are investigated.

MeSH Terms

Conditions

Subarachnoid HemorrhageAcute Lung InjurySystemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsLung InjuryLung DiseasesRespiratory Tract DiseasesInflammationShock

Study Officials

  • Kirsten Møller, Prof

    Neurointensive Care Unit, The Neuroscience Center, Rigshospitalet

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 28, 2014

First Posted

December 19, 2014

Study Start

November 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

DK(1)