NCT02991157

Brief Summary

This prospective observational study will assess the regional cerebral oxygen saturation and cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine administration for the prevention/management of cerebral vasospasm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

December 7, 2016

Last Update Submit

March 23, 2019

Conditions

Subarachnoid Hemorrhage, Aneurysmal

Keywords

cerebral vasospasmnimodipine

Outcome Measures

Primary Outcomes (1)

  • Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine

    Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine

Secondary Outcomes (2)

  • Change in the cardiac output measured using near NICOM technology after administration of nimodipine

    Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine

  • Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine

    Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine

Interventions

NimodipineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

aneurysmal subarachnoid hemorrhage with cerebral vasospasm

You may qualify if:

  • aneurysmal subarachnoid hemorrhage
  • potential or actual cerebral vasospasm

You may not qualify if:

  • non-aneurysmal subarachnoid hemorrhage
  • outside the 4-21 day window after ictus
  • peripheral deoxygenation
  • contraindication for nimodipine administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIMHANS

Bengaluru, India

Location

MeSH Terms

Conditions

Subarachnoid HemorrhageVasospasm, Intracranial

Interventions

Nimodipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNicotinic Acids

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 13, 2016

Study Start

December 1, 2016

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

IN(1)