Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/27/2013 |
Start Date: | April 2010 |
End Date: | December 2011 |
Contact: | Miriam Treggiari, MD |
Email: | treggmm@u.washington.edu |
Phone: | 206-744-3059 |
The purpose of our study is to determine how well Triple-H works and how safe it is. The
investigators are hoping to determine the effects of starting the therapy early and to
explore if hypervolemia and/or hypertension are beneficial, and what the optimal target
ranges are.
Efficacy of Triple-H therapy.
Inclusion Criteria:
1. Age more than or equal to 18 years
2. Aneurysmal SAH of any clinical grade
3. Head computed tomography demonstrating SAH
4. Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location
that explains the SAH
5. Treatment of aneurysm with clipping or coiling must be carried out prior to
randomization and within 72 hours of bleeding
6. Signed consent by study participant or applicable legal representative within 72
hours after SAH
Exclusion Criteria:
1. History of traumatic SAH
2. Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography
3. Presence of an unsecured intracranial aneurysm(s) at risk of rupture that in the
opinion of the Investigator would compromise the safety of the patient or the quality
of the data
4. Delayed referral with clipping/coiling greater than 72 hours after the initial
bleeding
5. Time of symptom onset cannot be reliably determined
6. Intracranial hypertension (ICP >25 mm Hg) at the time of screening
7. History within the past six months and/or physical findings on admission of
decompensated congestive heart failure (NYHA functional class III or IV, or objective
class C or D)
8. Acute, evolving or recent myocardial infarction
9. Cardiac arrhythmia or second and third degree atrio-ventricular block causing
hemodynamic instability
10. Chronic renal failure requiring dialysis
11. Suspected or confirmed pregnancy
12. Non English speaking
13. A condition that would preclude the performance of the neurobehavioral test battery
due to a prior diagnosis of Alzheimer's disease, stroke, degenerative condition,
cerebral tumor, or mental retardation
14. Severe terminal disease with life expectancy less than 6 months
15. Refusal of consent
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