Advertisement

Topics

Preconditioning for Aneurismal Subarachnoid Hemorrhage

2014-08-27 03:14:12 | BioPortfolio

Summary

In remote preconditioning, ischemia in one organ protects distant organs from ischemic insults. e.g. brief induced limb ischemia protects the brain from an otherwise more severe stroke.

The objective of this study is to determine if remote ischemic preconditioning can be safely and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for developing disabling cerebral ischemia. The investigators will also preliminarily assess if there is evidence for neuroprotection. This will be a Phase 1b study.

Additional objectives are:

1. to determine if remote ischemic preconditioning can be safely and effectively instituted in patients with subarachnoid hemorrhage, who are at high risk for developing disabling cerebral ischemia.

2. analogously to a dose-escalation study the investigators propose to study the safety and tolerability of increasing durations of limb ischemia until a target time of 10 minutes of limb ischemia has been reached.

Description

The investigators propose to study patients with subarachnoid hemorrhage, who generally have a high risk of ischemic stroke in the 2 weeks following the initial bleed, and patients with clipped or coiled aneurysm. The investigators will apply a blood pressure cuff around leg and use it to interrupt the circulation for 5-10 minutes. The investigators will repeat this for a total of 3 times every 24 to 48 hours up to 14 days. The cuff will be inflated for 5-10 minutes and then deflated for 5 minutes. There will be 3 cycles of this. The cuff will be inflated to 200mmHg.

The investigators will first start with 5 minutes of cuff inflation to either the arm or leg. The investigators will determine if this is safe in at least 6 patients. The investigators will then increase the duration of cuff inflation to 7.5 minutes for another 6 patients. If no adverse events are noted the investigators will the proceed to study 10 minutes of inflation in another 6 patients. If no side effects are noted the investigators will then determine that this is well tolerated.

The study will be monitored by a Data Safety Monitoring Board who will make decisions about escalating the duration of cuff inflation. If 2 or more patients develop an adverse event that is related to the procedure the investigators will stop and no longer continue at that level of cuff inflation and the previous level of cuff inflation will be determined to be the safe and tolerated level.

The investigators will collect safety data on adverse events such as tolerability, local tissue trauma or deep vein thrombosis.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Subarachnoid Hemorrhage

Intervention

remote limb preconditioning

Location

Jackson Memorial Hospital
Miami
Florida
United States
33136

Status

Recruiting

Source

University of Miami

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:12-0400

Clinical Trials [983 Associated Clinical Trials listed on BioPortfolio]

Remote Ischemic Preconditioning in Subarachnoid Hemorrhage

Rupture of brain aneurysms is a common cause of death and disability, accounting for as many as 10% of stroke cases in the United States. While much of the resulting injury to the nervous ...

Remote Ischemic Limb Preconditioning In Healthy Volunteers

We would like to determine if remote ischemic leg preconditioning in healthy volunteers improves cerebral vasomotor reactivity as measured by breath holding and transcranial doppler vasomo...

Remote Preconditioning and Myocardial Protection

Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.

Effect of Remote Preconditioning in Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery

In recent several clinical trials, remote preconditioning showed very powerful myocardial protection. However, the myocardial protective effect by remote preconditioning was not evaluated ...

Effects of Limb Remote Ischemic Preconditioning for Prevention of Delirium in Elderly Patients After Non-cardiac Surgery

To investigate whether limb remote ischemic preconditioning (LRIP) could safely decrease the incidence of delirium in elderly patients after non-cardiac surgery.

PubMed Articles [2355 Associated PubMed Articles listed on BioPortfolio]

Comparison of cerebral perfusion in perimesencephalic subarachnoid hemorrhage and aneurysmal subarachnoid hemorrhage.

Perimesencephalic hemorrhage (PMH) is a benign subtype of nonaneurysmal subarachnoid hemorrhage (SAH). We aimed to investigate if cerebral perfusion in PMH is less affected than in aneurysmal SAH (aSA...

Convexity subarachnoid hemorrhage: clinical features and etiology of an Argentinian cohort.

Nontraumatic convexity subarachnoid hemorrhage is an increasingly recognized subtype of subarachnoid bleeding.

Intraventricular hemorrhage due to subarachnoid hemorrhage: Does the severity matter?

Aneurysm rupture might be accompanied by intraventricular hemorrhage (IVH) that is associated with poor outcome of subarachnoid hemorrhage (SAH). The aim of this study was to analyze risk factors and ...

Practical Pearl: Use of MRI to Differentiate Pseudo-subarachnoid Hemorrhage from True Subarachnoid Hemorrhage.

Remote acute subarachnoid hemorrhage after drainage of chronic subdural hematoma: A case report and review of the literature.

Chronic subdural hematoma(CSDH) can be treated by a relatively simple burr hole surgery. Acute subarachnoid hemorrhage (SAH) occurring after surgery for CSDH has been reported as a rare but severe com...

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)

Consultation via remote telecommunications, generally for the purpose of diagnosis or treatment of a patient at a site remote from the patient or primary physician.

Distinct regions of mesenchymal outgrowth at both flanks of an embryo during the SOMITE period. Limb buds, covered by ECTODERM, give rise to forelimb, hindlimb, and eventual functional limb structures. Limb bud cultures are used to study CELL DIFFERENTIATION; ORGANOGENESIS; and MORPHOGENESIS.

More From BioPortfolio on "Preconditioning for Aneurismal Subarachnoid Hemorrhage"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Stroke - Cerebrovascular Disease (CVA)
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is cut off. Strokes are a medical emergency and prompt treatment is essential because the sooner a person receives treatment for a stroke, the less damage is ...

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...


Searches Linking to this Trial