Treatment of Subarachnoid Hemorrhage With Human Albumin
Parole chiave
Astratto
Date
Ultimo verificato: | 11/30/2012 |
Primo inviato: | 06/22/2011 |
Iscrizione stimata inviata: | 12/09/2012 |
Primo pubblicato: | 12/10/2012 |
Ultimo aggiornamento inviato: | 12/09/2012 |
Ultimo aggiornamento pubblicato: | 12/10/2012 |
Data di inizio effettiva dello studio: | 05/31/2006 |
Data di completamento primaria stimata: | 06/30/2010 |
Data stimata di completamento dello studio: | 04/30/2011 |
Condizione o malattia
Intervento / trattamento
Drug: 25% human albumin
Fase
Gruppi di braccia
Braccio | Intervento / trattamento |
---|---|
Experimental: 25% human albumin Subjects will be entered into one of 4 increasing dosages of 25% human albumin sequentially. Once the first 20 subjects have been enrolled and the DSMB reviews data and approves moving to the next dosage tier patients will be entered into the following dosage tier. | Drug: 25% human albumin 25% human albumin given in four escalating doses:
Group 1: .625g/kg infused over 3hrs daily X 7day
Group 2: 1.25g/kg infused over 3hrs daily X 7day
Group 3: 1.875g/kg infused over 3hrs daily X 7day
Group 4: 2.5g/kg infused over 3hrs daily X 7day |
Criteri di idoneità
Età idonea per lo studio | 18 Years Per 18 Years |
Sessi idonei allo studio | All |
Accetta volontari sani | sì |
Criteri | Inclusion Criteria: - Patients (male or female) must be at least 18 but younger than 80 years of age. - Onset of new neurological signs of subarachnoid hemorrhage within 72 hours at the time of evaluation and initiation of treatment with 25% human albumin. - Clinical signs consistent with the diagnosis of subarachnoid hemorrhage including severe thunderclap headache, cranial nerve abnormalities, decreased level of consciousness, meningismus and focal neurological deficits. - Head computed tomography demonstrates subarachnoid hemorrhage (rating scale 2-4). - Cerebral angiography reveals the presence of saccular aneurysm(s) in a location that explains the subarachnoid hemorrhage. - Treatment of cerebral aneurysm must be carried out prior to treatment initiation but within 72 hours of symptom onset. Accepted treatments of aneurysms include surgical clipping or endovascular embolization. - Signed and dated informed written consent by the subject or his/her legally authorized representative. Exclusion Criteria: - Time of symptom onset cannot be reliably assessed. - No demonstrable aneurysm by cerebral angiography. - Evidence of traumatic, mycotic, or fusiform aneurysm by cerebral angiography. - World Federation of Neurological Surgeons scale of IV and V - Head computed tomography rating scale of 0 - 1 - History within the past 6 months, and/or physical findings on admission of decompensated heart failure (NYHA Class III and IV or heart failure requiring hospitalization). - Patient has received albumin prior to treatment assignment during the present admission. - Hospitalization for or diagnosis of acute myocardial infarction within the preceding 3 months. - Symptoms or electrocardiographic signs indicative of acute myocardial infarction on admission. - Electrocardiographic evidence and/or physical findings compatible with second- or third-degree heart block, or of cardiac arrhythmia associated with hemodynamic instability. - Echocardiogram performed before treatment revealing a left ventricular ejection fraction > or = 40% (if available). - Serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min. - Pregnancy, lactation or parturition within previous 30 days. - Known allergy to albumin. - Severe prior physical disability (Rankin Scale > 2) that precludes evaluation of clinical outcome measures. - History of severe chronic obstructive lung disease (FEV1 < 50% predicted, increased shortness of breath, and repeated exacerbations which have an impact on patients' quality of life). - History of confirmed or suspected liver failure (increased prothrombin time, elevated liver enzymes, hypoalbuminemia, and hyperbilirrubinemia with or without peripheral edema and encephalopathy) - Current participation in another drug treatment protocol. - Severe terminal disease with life expectancy less than 6 months. |
Risultato
Misure di esito primarie
1. Number of participatns with cardiovascular adverse events as a measure of safety and tolerability [Up to 48 hours after treatment administration]
Misure di esito secondarie
1. GOS [3 months after enrollment]
2. mRs [3 months after study enrollment]
3. NIHSS [3 months after enrollment]
4. SIS [3 months after enrollment]