Aneurysmal subarachnoid hemorrhage (SAH) remains a major cause of morbidity and mortality. Since the incidence peaks in mid-life, and since many survivors are permanently damaged, the human and economic costs are immense. Much of the death and disability is the acute and delayed result of blood in the subarachnoid space (e.g. vasospasm). However, an unknown - but we believe substantial - fraction of the adverse outcomes are a complication of surgery performed to obliterate the source of bleeding; as many as 25 percent of patients who undergo craniotomy for aneurysm clipping will have a new neurologic deficit when examined 12-24hrs postoperatively. This danger is well known, and almost all surgical teams utilize some method to protect patients during surgery, including barbiturates, etomidate, steroids, mannitol or varying degrees of hypothermia. Unfortunately, in spite of the popularity of such interventions, none has ever been systematically tested in humans (other than deep hypothermia and circulatory arrest), and none are known to provide any benefit at all. Of the aforementioned therapies, we believe the best laboratory evidence supports the use of hypothermia. Our goal, therefore, is to perform a prospective, randomized clinical trial to evaluate the safety and efficacy of intraoperative hypothermia (t=33 degrees C) as a means of reducing early and long-term postoperative neurologic morbidity following surgery for clipping of intracranial aneurysm. Control patients will remain normothermic during and after surgery; in hypothermic patients, body temperature will be normalized as quickly as possible after the aneurysm clip is in place. All other aspects of pre- and postoperative care will be managed routinely. We hypothesize that hypothermia, even when limited to the intraoperative period, will result in an improvement in neurologic outcome as measured by Glasgow Outcome Scale at 3months following surgery, and will also result in more rapid improvement during the first postoperative week.

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Research Project (R01)
Project #
5R01NS038554-05
Application #
6654376
Study Section
National Institute of Neurological Disorders and Stroke Initial Review Group (NSD)
Program Officer
Moy, Claudia S
Project Start
1999-09-05
Project End
2006-05-31
Budget Start
2003-06-01
Budget End
2006-05-31
Support Year
5
Fiscal Year
2003
Total Cost
$1,207,769
Indirect Cost
Name
University of Iowa
Department
Anesthesiology
Type
Schools of Medicine
DUNS #
062761671
City
Iowa City
State
IA
Country
United States
Zip Code
52242
Bayman, Emine O; Chaloner, Kathryn M; Hindman, Bradley J et al. (2013) Bayesian methods to determine performance differences and to quantify variability among centers in multi-center trials: the IHAST trial. BMC Med Res Methodol 13:5
Mahaney, Kelly B; Todd, Michael M; Bayman, Emine O et al. (2012) Acute postoperative neurological deterioration associated with surgery for ruptured intracranial aneurysm: incidence, predictors, and outcomes. J Neurosurg 116:1267-78
Mahaney, Kelly B; Todd, Michael M; Torner, James C et al. (2011) Variation of patient characteristics, management, and outcome with timing of surgery for aneurysmal subarachnoid hemorrhage. J Neurosurg 114:1045-53
Hindman, Bradley J; Bayman, Emine O; Pfisterer, Wolfgang K et al. (2010) No association between intraoperative hypothermia or supplemental protective drug and neurologic outcomes in patients undergoing temporary clipping during cerebral aneurysm surgery: findings from the Intraoperative Hypothermia for Aneurysm Surgery Trial. Anesthesiology 112:86-101
Nguyen, Hoang P; Zaroff, Jonathan G; Bayman, Emine O et al. (2010) Perioperative hypothermia (33 degrees C) does not increase the occurrence of cardiovascular events in patients undergoing cerebral aneurysm surgery: findings from the Intraoperative Hypothermia for Aneurysm Surgery Trial. Anesthesiology 113:327-42
Todd, Michael M; Hindman, Bradley J; Clarke, William R et al. (2009) Perioperative fever and outcome in surgical patients with aneurysmal subarachnoid hemorrhage. Neurosurgery 64:897-908; discussion 908
Pasternak, Jeffrey J; McGregor, Diana G; Lanier, William L et al. (2009) Effect of nitrous oxide use on long-term neurologic and neuropsychological outcome in patients who received temporary proximal artery occlusion during cerebral aneurysm clipping surgery. Anesthesiology 110:563-73
Coghlan, Landis A; Hindman, Bradley J; Bayman, Emine O et al. (2009) Independent associations between electrocardiographic abnormalities and outcomes in patients with aneurysmal subarachnoid hemorrhage: findings from the intraoperative hypothermia aneurysm surgery trial. Stroke 40:412-8
McGregor, Diana G; Lanier, William L; Pasternak, Jeffrey J et al. (2008) Effect of nitrous oxide on neurologic and neuropsychological function after intracranial aneurysm surgery. Anesthesiology 108:568-79
Leira, Enrique C; Davis, Patricia H; Martin, Coleman O et al. (2007) Improving prediction of outcome in ""good grade"" subarachnoid hemorrhage. Neurosurgery 61:470-3;discussion 473-4

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