NCT04311840

Brief Summary

Nimodipine can increase Functional Capillary Density (FCD) as a parameter of the sublingual microcirculation in patients with subarachnoid hemorrhage (SAH) compared to patients without nimodipine.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Typical duration 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

Study Start

First participant enrolled

November 1, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 27, 2022

Status Verified

September 1, 2022

Enrollment Period

3 years

First QC Date

November 18, 2019

Last Update Submit

September 25, 2022

Conditions

Subarachnoid Hemorrhage

Keywords

nimodipinesublingual microcirculationSide-stream Dark Field imaging

Outcome Measures

Primary Outcomes (2)

  • Functional capillary density (FCD)

    Parameter describing the perfusion of the microcirculation

    One week

  • Proportion of perfused vessels (PPV)

    Parameter describing the perfusion of the microcirculation

    One week

Secondary Outcomes (2)

  • Vasospasm occurence

    One week

  • Circulatory incoherence

    One week

Study Arms (2)

SAH patients with nimodipine

Patients with SAH receiving nimodipine as prevention of vasospasms and as a nootropic drug.

SAH patients without nimodipine

Patients with SAH not receiving nimodipine as prevention of vasospasms and as a nootropic drug or in whom the drug has been temporarily discontinued.

Eligibility Criteria

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

All adult patients admitted to the neurosurgical ICU with the diagnosis of subarachnoid hemorrhage. Might be alert, somnolent or sedated on mechanical ventilation. Might be after endovascular coiling or surgical clipping of the aneurysm.

You may qualify if:

  • adulthood
  • ICU admission
  • diagnosis of non-traumatic subarachnoid hemorrhage

You may not qualify if:

  • inherited coagulation disorder
  • rheumatic disease
  • microangiopathy
  • patient of representative refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, Třebeš, 50005, Czechia

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Central Study Contacts

David Astapenko, M.D., Ph.D.

CONTACT

+420608177374david.astapenko@fnhk.cz

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2019

First Posted

March 17, 2020

Study Start

November 1, 2019

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

September 27, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)