Trials / Suspended
SuspendedNCT02501434
Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin
A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients With Significant Hemorrhage Burden
- Status
- Suspended
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- Sponsor
- Robert F. James · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
A Blind-adjudication Multi-center Phase II Randomized Clinical Trial of Continuous Low-dose Intravenous Heparin Therapy in Coiled Low-grade Aneurysmal Subarachnoid Hemorrhage Patients with Significant Hemorrhage Burden. - STUDY IS TEMPORARILY SUSPENDED WITH PLAN TO RESUME SOON. NO SAFETY CONCERNS
Detailed description
The primary objective of this study is to investigate the safety and clinical effect of a continuous low-dose intravenous unfractionated heparin (LDIVH) infusion for the prevention of aneurysmal subarachnoid hemorrhage (aSAH) induced neurocognitive dysfunction and other delayed neurological deficits. Additionally, increased blood and CSF levels of certain inflammatory biomarkers (IL-6, hsCRP, etc) have been correlated to aSAH patients with poor clinical outcomes. Unfractionated heparin (UFH) has known anti-inflammatory actions. As a result, a secondary objective of this study will be to evaluate whether LDIVH can reduce blood and CSF inflammatory biomarkers levels compared to controls and whether there is any association between inflammatory biomarker levels and cognitive outcomes in aSAH.
Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Neurobehavioral Manifestations
- Vasospasm, Intracranial
- Intracranial Aneurysm
- Heparin-induced Thrombocytopenia Type II
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Continuous Low-Dose IV Unfractionated Heparin Infusion | Continuous intravenous infusion of a low-dose unfractionated heparin drip |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2023-01-01
- Completion
- 2024-01-01
- First posted
- 2015-07-17
- Last updated
- 2022-03-04
Locations
9 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02501434. Inclusion in this directory is not an endorsement.