Intensive Management of Pressure and Volume Expansion in Patients With Subarachnoid Hemorrhage

NCT ID: NCT01414894

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2012-12-31

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.

Detailed Description

Efficacy of Triple-H therapy.

Conditions

Subarachnoid Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Normal Fluids & Normal Blood Pressure

Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure).

Group Type: ACTIVE_COMPARATOR

Fluid manipulation

Intervention Type: OTHER

Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.

Blood Pressure Manipulation

Intervention Type: OTHER

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.

Increased Fluids & Normal Blood Pressure

Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a normal range (Conventional Blood Pressure)

Group Type: ACTIVE_COMPARATOR

Fluid manipulation

Intervention Type: OTHER

Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.

Blood Pressure Manipulation

Intervention Type: OTHER

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.

Normal Fluids & Higher Blood Pressure

Patients are treated with conventional fluid replacement (Normovolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).

Group Type: ACTIVE_COMPARATOR

Fluid manipulation

Intervention Type: OTHER

Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.

Blood Pressure Manipulation

Intervention Type: OTHER

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.

Increased Fluids & Higher Blood Pressure

Patients are treated with fluids to achieve higher volume expansion (Hypervolemia) and maintenance of blood pressure in a higher range (Augmented Blood Pressure).

Group Type: ACTIVE_COMPARATOR

Fluid manipulation

Intervention Type: OTHER

Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.

Blood Pressure Manipulation

Intervention Type: OTHER

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.

Interventions

Fluid manipulation

Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.

Intervention Type: OTHER

Blood Pressure Manipulation

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.

Intervention Type: OTHER

Other Intervention Names

Hypervolemia; Normovolemia; Conventional Blood Pressure; Augmented Blood Pressure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Miriam Treggiari

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miriam Treggiari, MD, PhH, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

References

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.

Reference Type: DERIVED

PMID: 25549192 (View on PubMed)

Other Identifiers

37222-A

Identifier Type: -

Identifier Source: org_study_id