Subarachnoid HemorrhagePhase 1IMPROVESNCT01414894
Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
A Phase 1 study testing Fluid manipulation and Blood Pressure Manipulation in people with Subarachnoid Hemorrhage, run by University of Washington.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Fluid manipulation and Blood Pressure Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
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.
Read the detailed description
Efficacy of Triple-H therapy.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Fluid manipulation, Blood Pressure Manipulation
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid manipulationOther
Also called Hypervolemia, Normovolemia
Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
Blood Pressure ManipulationOther
Also called Conventional Blood Pressure, Augmented Blood Pressure
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Fluids & Normal Blood Pressure | Active comparator | Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure). Receives: Other: Fluid manipulation; Other: Blood Pressure Manipulation |
| Increased Fluids & Normal Blood Pressure | Active comparator | Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure) Receives: Other: Fluid manipulation; Other: Blood Pressure Manipulation |
| Normal Fluids & Higher Blood Pressure | Active comparator | Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure). Receives: Other: Fluid manipulation; Other: Blood Pressure Manipulation |
| Increased Fluids & Higher Blood Pressure | Active comparator | Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure). Receives: Other: Fluid manipulation; Other: Blood Pressure Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.
- 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Treggiari, University of Washington
- Investigators
- Miriam Treggiari, MD, PhH, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414894
- Sponsor's protocol ID
- 37222-A
- Acronym
- IMPROVES
- Status last verified
- Jun 2013
- First submitted
- 5 Apr 2010
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25549192
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01414894
- Acronym / sponsor ID
- IMPROVES / 37222-A
- Conditions
- Subarachnoid Hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Efficacy of Triple-H therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Fluids & Normal Blood Pressure | Active comparator | Other: Fluid manipulation, Other: Blood Pressure ManipulationPatients 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 comparator | Other: Fluid manipulation, Other: Blood Pressure ManipulationPatients 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 comparator | Other: Fluid manipulation, Other: Blood Pressure ManipulationPatients 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 comparator | Other: Fluid manipulation, Other: Blood Pressure ManipulationPatients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluid manipulationAlso: Hypervolemia, NormovolemiaPatients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days. | Other | Increased Fluids & Higher Blood Pressure, Increased Fluids & Normal Blood Pressure, Normal Fluids & Higher Blood Pressure, Normal Fluids & Normal Blood Pressure |
| Blood Pressure ManipulationAlso: Conventional Blood Pressure, Augmented Blood PressurePatients 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. | Other | Increased Fluids & Higher Blood Pressure, Increased Fluids & Normal Blood Pressure, Normal Fluids & Higher Blood Pressure, Normal Fluids & Normal Blood Pressure |
Primary outcome
Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations.
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Derived from this study: PubMed 25549192Togashi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Treggiari, MD, PhH, MPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluid manipulation and Blood Pressure Manipulation in people with Subarachnoid Hemorrhage, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our primary endpoint is to determine the feasibility of the pilot study within the ICU setting and collect preliminary estimates for sample size calculations. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01414894, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.