Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
IMPROVES
1 other identifier
interventional
20
0 countries
N/A
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 and/or hypertension are beneficial, and what the optimal target ranges are.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2010
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 20, 2013
June 1, 2013
2.7 years
April 5, 2010
June 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.
1\. Estimation of the eligible population once specific study inclusion \& exclusion criteria are applied 2. Estimation of enrollment projections, retention, attrition \& losses to follow up; 3. Assessment of compliance with protocol instructions; 4. Evaluation of protocol violations; 5. Achievement of pre-determined hemodynamic goals in each study group.
6 months
Study Arms (4)
Normal Fluids & Normal Blood Pressure
ACTIVE COMPARATORPatients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure).
Increased Fluids & Normal Blood Pressure
ACTIVE COMPARATORPatients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure)
Normal Fluids & Higher Blood Pressure
ACTIVE COMPARATORPatients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).
Increased Fluids & Higher Blood Pressure
ACTIVE COMPARATORPatients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).
Interventions
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Togashi K, Joffe AM, Sekhar L, Kim L, Lam A, Yanez D, Broeckel-Elrod JA, Moore A, Deem S, Khandelwal N, Souter MJ, Treggiari MM. Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (IMPROVES). Neurosurgery. 2015 Feb;76(2):125-34; discussion 134-5; quiz 135. doi: 10.1227/NEU.0000000000000592.
PMID: 25549192DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miriam Treggiari, MD, PhH, MPH
University of Washington
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 5, 2010
First Posted
August 11, 2011
Study Start
April 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
June 20, 2013
Record last verified: 2013-06