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NCT04311840 Clinical Trial

Impact of Nimodipine on Sublingual Microcirculation in Patients With Hemorrhage - a Prospective Monocentric Observational Study

Subarachnoid Hemorrhage Clinical Trial

Official title:
Impact of Nimodipine on Sublingual Microcirculation in Patients With Subarachnoid Hemorrhage - a Prospective Monocentric Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04311840
Other study ID # SAH_Nimodipine
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 31, 2022

Study information
Verified date September 2022
Source University Hospital Hradec Kralove
Contact David Astapenko, M.D., Ph.D.
Phone +420608177374
Email david.astapenko@fnhk.cz
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

SAH group - in patients with SAH and documented vasospasms by digital subtraction angiography (DSA) of trans-cranial doppler imaging (TCD) of arteria cerebri media nimodipine is indicated because it is proven to improve the clinical outcome. The disfunction of cerebral microcirculation in rats with SAH has been documented [1-6]. Changes in sublingual microcirculation in patients with SAH with documented vasospasms with nimodipine has not been described.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date December 31, 2022
Est. primary completion date October 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adulthood - ICU admission - diagnosis of non-traumatic subarachnoid hemorrhage Exclusion Criteria: - inherited coagulation disorder - rheumatic disease - microangiopathy - patient of representative refusal

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Czechia University Hospital Hradec Kralove Hradec Králové Trebeš

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functional capillary density (FCD) Parameter describing the perfusion of the microcirculation One week
Primary Proportion of perfused vessels (PPV) Parameter describing the perfusion of the microcirculation One week
Secondary Vasospasm occurence Occurence of vasospasms on angiography and/or transcranial Doppler One week
Secondary Circulatory incoherence Deranged microcirculation in patients on catecholamines One week
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