A Phase 1/2 interventional study of HTS 3% and Standard fluid management in Subarachnoid Hemorrhage, Cerebral Vasospasm and Hyponatremia, sponsored by Thomas Jefferson University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-11.
Sponsored by Thomas Jefferson University · Phase 1/2, Interventional, and Prevention
Subarachnoid hemorrhage (SAH) occurs after rupture of cerebral aneurysms. Treatment of SAH focuses on avoiding medical complications including cerebral vasospasm, which may result in limited circulation to the brain. Cerebral vasospasm, or thinning of the arteries of the brain, is a feared complication that could potentially cause stroke and worst outcomes after SAH. Hypertonic saline (HTS) is a compound that may be used to prevent vasospasm following SAH by enhancing the circulation in the brain. This study will evaluate if a protocol of volume expansion with HTS is safe and effective in patients with subarachnoid hemorrhage for the prevention of cerebral vasospasm.
This is a prospective, single-center, interventional, randomized, parallel, two-arm (1:1) phase II clinical trial with blinded end-point ascertainment designed to determine the safety and feasibility of a protocol of 3% hypertonic saline (HTS) as a "volume expander" administered within 72-hours of admission and up to 7-days in SAH patients compared to standard fluid management, in individuals with aneurysmal SAH. A common sequela of aneurysmal SAH is vasospasm, which causes significant morbidity and mortality. In addition, 30% of patients with SAH develop hypovolemic hyponatremia (serum sodium [Na] \<130mEq/L), predisposing them to develop cerebral ischemia. Current guidelines for the management of aneurysmal SAH recommend: (1) maintaining euvolemia in order to prevent delayed cerebral ischemia (DCI) and (2) using HTS as a treatment option for the prevention and treatment of hypovolemic hyponatremia. Treatment for vasospasm includes induction of hypertension, along with systemic and/or intra-arterial administration of calcium channel blockers, or angioplasty. The investigators will (1) measure the incidence of severe adverse events from our protocol of HTS, (2) measure the incidence of cerebral vasospasm in patients treated with our protocol of HTS as compared to patients treated with standard fluid therapy; and (3) assess the burden of hypovolemic hyponatremia.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
This study's planned enrollment of 50 is close to the median of 52 across 263 interventional studies indexed under Subarachnoid Hemorrhage.
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Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
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Exclusion Criteria:
A protocol of prophylactic 3% HTS as a volume expander with bolus (over 30 minutes) of 3% HTS at a dose of 250 ml every 6 hours for 7 days. This will be given through a central line as soon as possible and within 72 hours of onset of SAH symptoms.
Drug: HTS 3%
Routine fluid management strategy as pre-specified by our SAH management protocol at Jefferson University Hospital according to the American Heart Association and Neurocritical Care Guidelines for the management of SAH (this includes conventional intravenous fluids or normal saline solutions to maintain a normal hydration status and guided by the treating doctor and daily assessments of fluid balance).
Drug: Standard fluid management
3% HTS at a dose of 250 ml every 6 hours for 7 days
Routine fluid management strategy as pre-specified by our SAH management protocol.
Safety (adverse events)
Incidence or proportion of serious adverse events
Time frame: 21 days
Feasibility (Proportion of patients treated according to the protocol)
Proportion of patients treated according to the protocol
Time frame: 21 days
Vasospasm (Incidence of cerebral vasospasm defined as clinical deterioration)
Incidence of cerebral vasospasm defined as clinical deterioration (focal deficit or decline in Glasgow Coma Scale (GCS) score of \>/=2 points by neurological exam), or transcranial doppler (TCD) velocity increase with mean blood flow \> 120 cm/sec, or arterial narrowing (mod-sec) on DSA or CTA.
Time frame: 21 days
Hyponatremia (Incidence of hypovolemic hyponatremia defined as Na <135)
Incidence of hypovolemic hyponatremia defined as Na \<135
Time frame: 21 days
This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University