Status:
COMPLETED
Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
Lead Sponsor:
University of Washington
Conditions:
Subarachnoid Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
Efficacy of Triple-H therapy.
Eligibility Criteria
Inclusion
- Age more than or equal to 18 years
- Aneurysmal SAH of any clinical grade
- Head computed tomography demonstrating SAH
- Cerebral angiography revealing the presence of cerebral aneurysm(s) in a location that explains the SAH
- Treatment of aneurysm with clipping or coiling must be carried out prior to randomization and within 72 hours of bleeding
- Signed consent by study participant or applicable legal representative within 72 hours after SAH
Exclusion
- History of traumatic SAH
- Non-aneurysmal SAH as indicated by no demonstrable aneurysm by cerebral angiography
- 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
- Delayed referral with clipping/coiling greater than 72 hours after the initial bleeding
- Time of symptom onset cannot be reliably determined
- Intracranial hypertension (ICP \>25 mm Hg) at the time of screening
- 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)
- Acute, evolving or recent myocardial infarction
- Cardiac arrhythmia or second and third degree atrio-ventricular block causing hemodynamic instability
- Chronic renal failure requiring dialysis
- Suspected or confirmed pregnancy
- Non English speaking
- 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
- Severe terminal disease with life expectancy less than 6 months
- Refusal of consent
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01414894
Start Date
April 1 2010
End Date
December 1 2012
Last Update
June 20 2013
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