Topics

A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping

2020-02-17 18:20:36 | BioPortfolio

Summary

This study of NicaPlant® is conducted in patients who have a subarachnoid haemorrhage. Patients will be randomized in two treatment groups. Both groups will receive the standard of care and the investigational group will receive in addition NicaPlant®. NicaPlant® is tested to reduce the long-term complications of aneurysmal subarachnoid haemorrhage (aSAH).

Description

This is a safety, tolerability, efficacy and pharmacokinetic study of NicaPlant® in subarachnoid haemorrhage patients involving two treatment groups. Both treatment groups will receive standard of care and patients randomised to the investigational group will receive in addition NicaPlant® .

NicaPlant® is a nicardipine modified-release formulation. It is presented in the form of a rod-shaped implant with a 4 mg nicardipine load. Following aneurysm clip ligation, 10 NicaPlant® implants will be placed into the basal cisterns in direct contact with the exposed cerebral blood vessel walls.

Study Design

Conditions

Aneurysmal Subarachnoid Hemorrhage

Intervention

Nicardipine, Standard of care

Location

Universitätsklinik Innsbruck, Universitätsklinik für Neurochirurgie
Innsbruck
Austria
6020

Status

Recruiting

Source

BIT Pharma GmbH

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-02-17T18:20:36-0500

Clinical Trials [1566 Associated Clinical Trials listed on BioPortfolio]

Study of EG-1962 Compared to Standard of Care Oral Nimodipine in Adults With Aneurysmal Subarachnoid Hemorrhage

This study compares EG-1962 to enteral nimodipine in the treatment of aneurysmal subarachnoid hemorrhage.

A Multicenter Registry Study of Aneurysmal SAH

Firstly, this study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the influencing factors contributing...

Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin

A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients with...

New Therapeutic System of Ruptured Intracranial Aneurysms Based on Big Data From Chinese Population

This study aims at clarifying the current situation of Emergency treatment of aneurysmal subarachnoid hemorrhage (SAH) in China, and analyzing the safety and efficacy of the treatment stra...

Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.

PubMed Articles [15155 Associated PubMed Articles listed on BioPortfolio]

Between-center and between-country differences in outcome after aneurysmal subarachnoid hemorrhage in the Subarachnoid Hemorrhage International Trialists (SAHIT) repository.

Differences in clinical outcomes between centers and countries may reflect variation in patient characteristics, diagnostic and therapeutic policies, or quality of care. The purpose of this study was ...

Long-term Neuropsychiatric and Neuropsychological Sequelae of Endovascularly Treated Aneurysmal Subarachnoid Hemorrhage.

There is limited evidence regarding long-term outcomes of aneurysmal subarachnoid hemorrhage survivors. Most follow-up programs are relatively short and focused on physical functions. Endovascular ane...

Reduced Admission Serum Fibrinogen Predict 6-month Mortality of Poor-Grade Aneurysmal Subarachnoid Hemorrhage.

To retrospectively analyzed the relationship between fibrinogen and outcomes in poor-grade aneurysmal subarachnoid hemorrhage (aSAH).

Endogenous arterial blood pressure increase after aneurysmal subarachnoid hemorrhage.

Spontaneous blood pressure rise is a frequently observed phenomenon following aneurysmal subarachnoid hemorrhage (SAH). Facing the risk of aneurysmal rebleeding and the occurrence of delayed cerebral ...

Whole blood levels of S1PR4 mRNA associated with cerebral vasospasm after aneurysmal subarachnoid hemorrhage.

The authors sought to identify mRNA biomarkers of cerebral vasospasm in whole blood of patients suffering from aneurysmal subarachnoid hemorrhage (aSAH).

Medical and Biotech [MESH] Definitions

Bleeding into the intracranial or spinal SUBARACHNOID SPACE, most resulting from INTRACRANIAL ANEURYSM rupture. It can occur after traumatic injuries (SUBARACHNOID HEMORRHAGE, TRAUMATIC). Clinical features include HEADACHE; NAUSEA; VOMITING, nuchal rigidity, variable neurological deficits and reduced mental status.

Bleeding into the SUBARACHNOID SPACE due to CRANIOCEREBRAL TRAUMA. Minor hemorrhages may be asymptomatic; moderate to severe hemorrhages may be associated with INTRACRANIAL HYPERTENSION and VASOSPASM, INTRACRANIAL.

Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)

The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.

Bleeding within the SKULL induced by penetrating and nonpenetrating traumatic injuries, including hemorrhages into the tissues of CEREBRUM; BRAIN STEM; and CEREBELLUM; as well as into the epidural, subdural and subarachnoid spaces of the MENINGES.

More From BioPortfolio on "A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping"

Quick Search

Searches Linking to this Trial