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01-10-2010 | Taking A Closer Look At Trials

Treatment of Subarachnoid Hemorrhage with Human Albumin: ALISAH Study. Rationale and Design

Authors: Jose I. Suarez, Renee H. Martin

Published in: Neurocritical Care | Issue 2/2010

Abstract

The primary objective of this prospective dose-finding pilot study is to demonstrate the tolerability and safety of four dosages of 25% human albumin in patients with subarachnoid hemorrhage (SAH). For each dosage group, the study will enroll 20 patients who meet the eligibility criteria. The enrolled patients will undergo follow-up for 90 days post-treatment. The primary tolerability hypothesis is that intravenous 25% human albumin can be given without precipitating treatment related serious adverse events beyond expectations. The study will determine the maximum tolerated dosage of 25% human albumin therapy based on the rate of treatment related serious adverse events during treatment: severe or life-threatening heart failure. The secondary objectives are to obtain preliminary estimates of the albumin treatment effect using the incidence of neurological deterioration within 15 days after symptom onset. In addition, the incidence of rebleeding, hydrocephalus, seizures, delayed cerebral ischemia and the incidence of vasospasm (both symptomatic and by transcranial Doppler ultrasound criteria) within 15 days after symptom onset will be evaluated. Furthermore, the serum osmolality and serum albumin concentrations, serum magnesium concentration, blood pressure and heart rate within 15 days of symptom onset will also be observed. The Glasgow Outcome Scale, Barthel Index, modified Rankin Scale, NIH Stroke Scale, and Stroke Impact Scale will be performed 3 months after the onset of symptoms to assess residual neurological deficits.

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Sudlow CLM, Warlow CP. Comparable studies of the incidence of stroke and its pathological types. Results from an international collaboration. Stroke. 1997;28:491–9.PubMed

Mayberg MR, Batjer HH, Dacey R, et al. Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage. A statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Stroke. 1994;25:2315–28.PubMed

van Gijn J, Rinkel JE. Subarachnoid haemorrhage: diagnosis, causes and management. Brain. 2001;124:249–78.CrossRefPubMed

Hop JW, Rinkel GJ, Algra A, van Gijn J. Case-fatality rates and functional outcome after subarachnoid hemorrhage: a systematic review. Stroke. 1997;28:660–4.PubMed

Johnston SC, Selvin S, Gress DR. The burden, trends, and demographics of mortality from subarachnoid hemorrhage. Neurology. 1998;50:1413–8.PubMed

Roos YBWEM, Dijkgraaf MGW, Albrecht KW, et al. Direct costs of modern treatment of aneurysmal subarachnoid hemorrhage in the first year after diagnosis. Stroke. 2002;33:1595–9.CrossRefPubMed

Haley EC, Kassell NF, Torner JC. A randomized controlled trial of high-dose intravenous nicardipine in aneurysmal subarachnoid hemorrhage. J Neurosurg. 1993;78:537–47.CrossRefPubMed

Haley EC, Kassell NF, Torner JC. A randomized trial of nicardipine in subarachnoid hemorrhage: angiographic and transcranial Doppler ultrasound results. J Neurosurg. 1993;78:548–53.CrossRefPubMed

Hijdra A, van Gijn J, Nagelkerke NJD, Vermeulen M, van Crevel H. Prediction of delayed cerebral ischemia, rebleeding, and outcome after aneurysmal subarachnoid hemorrhage. Stroke. 1988;19:1250–6.PubMed

10.

Hijdra A, Vermeulen M, van Gijn J, van Crevel H. Rerupture of intracranial aneurysms: a clinicoanatomic study. J Neurosurg. 1987;67:29–33.CrossRefPubMed

11.

Kassell NF, Torner JC, Haley EC, et al. The international cooperative study on the timing of aneurysm surgery. Part 1: overall management results. J Neurosurg. 1990;73:18–36.CrossRefPubMed

12.

Kassell NF, Torner JC, Jane JA, Haley EC, Adams HP. The international cooperative study on the timing of aneurysm surgery. Part 2; surgical results. J Neurosurg. 1990;73:37–47.CrossRefPubMed

13.

Solenski N, Haley EC, Kassell NF, et al. Medical complications of aneurysmal subarachnoid hemorrhage: a report of the multicenter, cooperative aneurysm study. Crit Care Med. 1995;23:1007–17.CrossRefPubMed

14.

van Gijn J, Bromberg JEC, Lindsay KW, Hasan D, Vermeulen M. Definition of initial grading, specific events, and overall outcome in patients with aneurysmal subarachnoid hemorrhage. Stroke. 1994;25:1623–7.PubMed

15.

Hijdra A, van Gijn J, Stefanko S, van Dongen KJ, Vermeulen M, van Crevel H. Delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage: clinicoanatomic correlations. Neurology. 1986;36:329–33.PubMed

16.

Dietrich HH, Dacey RG. Molecular keys to the problems of cerebral vasospasm. Neurosurgery. 2000;46:517–30.CrossRefPubMed

17.

Macdonald RL. Pathophysiology and molecular genetics of vasospasm. Acta Neurochir. 2001;S77:7–11.

18.

Bulter WE, Peterson JW, Zervas NT, Morgan KG. Intracellular calcium, myosin light chain phosphorylation, and contractile force in experimental cerebral vasospasm. Neurosurgery. 1996;38:781–8.PubMed

19.

Koide M, Nishizawa S, Ohta S, Yokoyama T, Namba H. Chronological changes of the contractile mechanism in prolonged vasospasm after subarachnoid hemorrhage: from protein kinase C to protein tyrosine kinase. Neurosurgery. 2002;51:1468–76.CrossRefPubMed

20.

Laher I, Zhang JH. Protein kinase C and cerebral vasospasm. J Cereb Blood Flow. 2001;2:887–906.CrossRef

21.

Clatterbuck RE, Oshiro EM, Hoffman PA, Dietsch GN, Pardoli DM, Tamargo RJ. Inhibition of vasospasm with lymphocyte function-associated antigen-1 monoclonal antibody in a femoral artery model in rats. J Neurosurg. 2002;97:676–82.CrossRefPubMed

22.

Mocco J, Mack WJ, Kim GH, et al. Rise in serum soluble intercellular adhesion molecule-1 levels with vasospasm following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2002;97:537–41.CrossRefPubMed

23.

Sercombe R, Dinh YR, Gomis P. Cerebrovascular inflammation following subarachnoid hemorrhage. Jpn J Pharmacol. 2002;88:227–49.CrossRefPubMed

24.

Thai Q-A, Oshiro EM, Tamargo RJ. Inhibition of experimental vasospasm in rats with the periadventitial administration of ibuprofen using controlled-release polymers. Stroke. 1999;30:140–7.PubMed

25.

Borel CO, McKee A, Parra A, et al. Possible role for vascular cell proliferation in cerebral vasospasm after subarachnoid hemorrhage. Stroke. 2003;34:427–33.CrossRefPubMed

26.

McGirt MJ, Lynch JR, Blessing R, et al. Serum von Willebrand factor, matrix metalloproteinase-9, and vascular-endothelial growth factor levels predict the onset of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Neurosurgery. 2002;51:1128–35.CrossRefPubMed

27.

Ono S, Komuro T, Macdonald LR. Heme oxygenase-1 gene therapy for prevention of vasospasm in rats. J Neurosurg. 2002;96:1094–102.CrossRefPubMed

28.

Auer LM. Acute operation and preventive nimodipine improve outcome in patients with ruptured cerebral aneurysms. Neurosurgery. 1984;15:57–66.CrossRefPubMed

29.

Flamm ES, Adams HP, Beck DW, et al. Dose-escalation study of intravenous nicardipine in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 1988;68:393–400.CrossRefPubMed

30.

Gilsbach JM, Reulen HJ, Ljunggren B, et al. Early aneurysm surgery and preventive therapy with intravenously administered nimodipine: a multicenter, double-blind, dose-comparison study. Neurosurgery. 1990;26:458–64.CrossRefPubMed

31.

Petruk KC, West M, Mohr G, et al. Nimodipine treatment in poor-grade aneurysm patients. J Neurosurg. 1988;68:505–17.CrossRefPubMed

32.

Pickard JD, Murray GD, Illingworth R, et al. Effect of oral nimodipine on cerebral infarction and outcome after subarachnoid hemorrhage: British aneurysm nimodipine trial. BMJ. 1989;298:636–42.CrossRefPubMed

33.

Rinkel GJ, Feigin VL, Algra A, Vermeulen M, van Gijn J. Calcium antagonists for aneurysmal subarachnoid hemorrhage. Cochrane Database Syst Rev. 2000;4:CD000277.

34.

Alderson P, Schierhout G, Roberts I, Bunn F. Colloid versus crystalloids for fluid resuscitation in critically ill patients. Cochrane Database Syst Rev. 2000;2:CD000567.PubMed

35.

The SAFE Study Investigators. A comparison of albumin and saline for fluid resuscitation in the intensive care unit. N Engl J Med. 2004;350:2247–56.CrossRef

36.

Wilkes MM, Navickis RJ. Patient survival after human albumin administration. Ann Intern Med. 2001;135:149–64.PubMed

37.

Belayev L, Busto R, Zhao W, Clemens JA, Ginsberg MD. Effect of delayed albumin hemodilution on infarction volume and brain edema after transient middle cerebral artery occlusion in rats. J Neurosurg. 1997;87:595–601.CrossRefPubMed

38.

Belayev L, Liu Y, Zhao W, Busto R, Ginsberg MD. Human albumin therapy of acute ischemic stroke: marked neuroprotective efficacy at moderate doses and with a broad therapeutic window. Stroke. 2001;32:553–60.PubMed

39.

Belayev L, Pinard E, Nallet H, et al. Albumin therapy of transient focal cerebral ischemia: in vivo analysis of dynamic microvascular responses. Stroke. 2002;33:1077–84.CrossRefPubMed

40.

Belayev L, Saul I, Huh PW, et al. Neuroprotective effect of high-dose albumin therapy against global ischemic brain injury in rats. Brain Res. 1999;845:107–11.CrossRefPubMed

41.

Cole DJ, Drummond JC, Osborne TN, Matsumura J. Hypertension and hemodilution during cerebral ischemia reduce brain injury and edema. Am J Physiol. 1990;259:H211–7.PubMed

42.

Huh PW, Belayev L, Zhao W, Busto R, Saul I, Ginsberg MD. The effect of high-dose albumin therapy on local cerebral perfusion after transient focal cerebral ischemia in rats. Brain Res. 1998;804:105–13.CrossRefPubMed

43.

Liu Y, Belayev L, Zhao W, Busto R, Belayev A, Ginsberg MD. Neuroprotective effect of treatment with human albumin in permanent focal cerebral ischemia: histopathology and cortical perfusion studies. Eur J Pharmacol. 2001;428:193–201.CrossRefPubMed

44.

Matsui T, Sinyama H, Asano T. Beneficial effect of prolonged administration of albumin on ischemic cerebral edema and infarction after occlusion of middle cerebral artery in rats. Neurosurgery. 1993;33:293–300.CrossRefPubMed

45.

Belayev L, Alonso OF, Huh PW, Zhao W, Busto R, Ginsberg MD. Posttreatment with high-dose albumin reduces histopathological damage and improves neurological deficit following fluid percussion brain injury in rats. J Neurotrauma. 1999;16:445–53.CrossRefPubMed

46.

Matsui T, Asano T. The hemodynamic effects of prolonged albumin administration in beagle dogs exposed to experimental subarachnoid hemorrhage. Neurosurgery. 1993;32:79–83.CrossRefPubMed

47.

Belayev L, Zhao W, Pattany PM, et al. Diffusion-weighted resonance imaging confirms marked neuroprotective efficacy of albumin therapy in focal cerebral ischemia. Stroke. 1998;29:2587–99.PubMed

48.

Asplund K. Hemodilution for acute ischemic stroke. Cochrane Database Syst Rev. 2002;4:CD000103.PubMed

49.

Tomita H, Ito U, Tone O, Masaoka H, Tominaga B. High colloid oncotic therapy for contusional brain edema. Acta Neurochir Suppl (Wien). 1994;60:547–9.

50.

Egge A, Waterloo K, Sjoholm H, Solberg T, Ingebrigten T, Romner B. Prophylactic hyperdynamic postoperative fluid therapy after aneurysmal subarachnoid hemorrhage: a clinical, prospective, randomized, controlled study. Neurosurgery. 2001;49:593–606.CrossRefPubMed

51.

Lennihan L, Mayer SA, Fink ME, et al. Effect of hypervolemic therapy on cerebral blood flow after subarachnoid hemorrhage: a randomized controlled trial. Stroke. 2000;31:383–91.PubMed

52.

Mayer SA, Solomon RA, Fink ME, et al. Effect of 5% albumin solution on sodium balance and blood volume after subarachnoid hemorrhage. Neurosurgery. 1998;42:759–68.CrossRefPubMed

53.

Ginsberg MD, Hill MD, Palesch YY, Ryckborst KJ, Tamariz D. The ALIAS Pilto Trial: a dose-escalation and safety study of albumin therapy for acute ischemic stroke—I: physiological responses and safety results. Stroke. 2006;37:2100–6.CrossRefPubMed

54.

Palesch YY, Hill MD, Ryckborst KJ, Tamariz D, Ginsberg MD. The ALIAS Pilot Trial. A dose-escalation and safety study of albumin therapy for acute ischemic stroke-II: neurologic outcome and efficacy analysis. Stroke. 2006;37:2107–14.CrossRefPubMed

55.

Suarez JI, Shannon L, Zaidat OO, et al. Effect of human albumin administration on clinical outcome and hospital cost in patients with SAH. J Neurosurg. 2004;100:585–90.CrossRefPubMed

56.

Hunt WE, Hess RM. Surgical risk as related to time of intervention in the repair of intracranial aneurysms. J Neurosurg. 1968;28:14–20.CrossRefPubMed

57.

Lindsay KW, Teasdale G, Knill-Jones RP, Murray L. Observer variability in grading patients with subarachnoid hemorrhage. J Neurosurg. 1982;56:628–33.CrossRefPubMed

58.

Lindsay KW, Teasdale GM, Knill-Jones RP. Observer variability in assessing the clinical features of subarachnoid hemorrhage. J Neurosurg. 1983;58:57–62.CrossRefPubMed

59.

Drake CG, Hunt WE, Sano K, et al. Report of World Federation of Neurological Surgeons Committee on a Universal Subarachnoid Hemorrhage Grading Scale. J Neurosurg. 1988;68:985–6.

60.

Teasdale G, Jennett B. Assessment of coma and impaired consciousness: a practical scale. Lancet. 1977;2:81–4.

61.

Teasdale G, Knill-Jones R, van der Sande J. Observer variability in assessing impaired consciousness and coma. J Neurol Neurosurg Psychiatry. 1978;41:603–10.CrossRefPubMed

62.

Adams HP, Kassell NF, Torner JC, Haley EC. Predicting cerebral ischemia after aneurismal subarachnoid hemorrhage: influences of clinical condition, CT results, and antifibrinolytic therapy. A report of the Cooperative Aneurysm Study. Neurology. 1987;37:1586–91.PubMed

63.

Claassen J, Bernardini GL, Kreiter K, et al. Effect of cisternal and ventricular blood on risk pf delayed cerebral ischemia after subarachnoid hemorrhage. The Fisher Scale revisited. Stroke. 2001;32:2012–20.CrossRefPubMed

64.

Suarez JI, Qureshi AI, Yahia AB, et al. Symptomatic vasospasm diagnosis after subarachnoid hemorrhage: evaluation of transcranial Doppler ultrasound and cerebral angiography as related to the compromised vascular distribution. Crit Care Med. 2002;30:1348–55.CrossRefPubMed

65.

Hunt SA, Baker DW, Chin MH, et al. ACC/AHA Guidelines for the evaluation and management of chronic heart failure in the adult: Executive summary. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1995 Guidelines for the Evaluation and Management of Heart Failure). Circulation. 2001;104:2996–3007.CrossRefPubMed

66.

Peters T. The albumin molecule: its structure and chemical properties. In: Peters T, editor. All about albumin: biochemistry, genetics, and clinical applications. San Diego: Academic Press; 1996. p. 9–75.

67.

Ring J, Messmer K. Incidence and severity of anaphylactoid reactions to colloid volume substitutes. Lancet. 1977;1(8009):466–9.CrossRefPubMed

68.

Torner JC, Nibbelink DW, Burmeister LF. Statistical comparisons of end results of a randomized treatment study. In: Sahs AL, Nibbelink DW, Torner JC, editors. Aneurysmal subarachnoid hemorrhage-report of the Cooperative Study. Baltimore: Urban & Schwrtzenberg; 1981. p. 249–75.

69.

Suarez JI, Tarr R, Selman WR. Subarachnoid hemorrhage. Current concepts. N Engl J Med. 2006;354:387–96.CrossRefPubMed

70.

Muizelaar JP, Zwienenberg M, Rudisill NA, Hecht ST. The prophylactic use of transluminal balloon angioplasty in patients with Fischer grade 3 subarachnoid hemorrhage: a pilot. J Neurosurg. 1999;91:51–8.CrossRefPubMed

71.

Hasan D, Wijdicks EFM, Vermeulen M. Hyponatremia is associated with cerebral ischemia in patients with aneurysmal subarachnoid hemorrhage. Ann Neurol. 1990;27:106–8.CrossRefPubMed

72.

Wijdicks EF, Vermeulen M, ten Haaf JA, Hijdra A, Bakker WH, van Gijn J. Volume depletion and natriuresis in patients with a ruptured intracranial aneurysm. Ann Neurol. 1985;18:211–6.CrossRefPubMed

73.

Newcombe RG. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med. 1998;17:857–72.CrossRefPubMed

74.

Bellone A, Monari A, Cortellano F, Vettorello M, Arlati S, Coen D. Myocardial infarction rate in acute pulmonary edema: noninvasive pressure support ventilation versus continuous positive airway pressure. Crit Care Med. 2004;32:1860–5.CrossRefPubMed

75.

Mehta S, Jay G, Woolard R, Hipona R, Connolly E, Cimini D, Drinkwine J, Hill N. Randomized, prospective trial of bilevel versus continuous positive airway pressure in acute pulmonary edema. Crit Care Med. 1997;25:620–8.CrossRefPubMed

76.

van Gijn J, Hijdra A, Widjicks EFM, Vermeulen M, van Crevel H. Acute hydrocephalus after aneurysmal subarachnoid hemorrhage. J Neurosurg. 1985;63:355–62.CrossRefPubMed

77.

Meese W, Kluge W, Grumme T, Hopfenmuller W. CT evaluation of the CSF spaces of healthy persons. Neuroradiology. 1980;19:131–6.CrossRefPubMed

Title: Treatment of Subarachnoid Hemorrhage with Human Albumin: ALISAH Study. Rationale and Design
Authors: Jose I. Suarez
Renee H. Martin
Publication date: 01-10-2010
Publisher: Humana Press Inc
Published in: Neurocritical Care / Issue 2/2010
Print ISSN: 1541-6933
Electronic ISSN: 1556-0961
DOI: https://doi.org/10.1007/s12028-010-9392-8

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Treatment of Subarachnoid Hemorrhage with Human Albumin: ALISAH Study. Rationale and Design

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

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