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

NCT ID: NCT04311840

Last Updated: 2022-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subarachnoid Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SAH patients with nimodipine

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* inherited coagulation disorder
* rheumatic disease
* microangiopathy
* patient of representative refusal
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Hradec Kralove

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Hradec Kralove

Hradec Králové, Třebeš, Czechia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Czechia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

+420608177374

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Pavel Dostal, M.D., Ph.D., MBA

Role: primary

+420495833218

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAH_Nimodipine

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of Minocycline in Intracerebral Hemorrhage
NCT03040128 COMPLETED PHASE1/PHASE2
Dexmedetomidine and Subarachnoid Haemorrhage
NCT01664520 COMPLETED PHASE1/PHASE2