drugset / Trial / NCT02350335
Transdermal Nicotine Replacement in Smokers With Acute Aneurysmal Subarachnoid Hemorrhage
RandomizedParallel-groupOpen-labelTreatment
Summary
All patients with acute aneurysmal hemorrhage are treated in accordance with our institutional protocol. After securing of the aneurysm, some smokers with acute aneurysmal hemorrhage are randomly assigned to transdermal nicotine replacement (NRT). The short- and long-term effect of NRT will be studied comparing non-smokers, smokers without NRT and smokers with NRT.
Timeline
- Start
- 2011-01
- Primary completion
- 2015-12
- Completion
- 2015-12
Publications
- Background Seder DB, Schmidt JM, Badjatia N, Fernandez L, Rincon F, Claassen J, Gordon E, Carrera E, Kurtz P, Lee K, Connolly ES, Mayer SA. Transdermal nicotine replacement therapy in cigarette smokers with acute subarachnoid hemorrhage. Neurocrit Care. 2011 Feb;14(1):77-83. doi: 10.1007/s12028-010-9456-9.
- Background Krishnamurthy S, Kelleher JP, Lehman EB, Cockroft KM. Effects of tobacco dose and length of exposure on delayed neurological deterioration and overall clinical outcome after aneurysmal subarachnoid hemorrhage. Neurosurgery. 2007 Sep;61(3):475-80; discussion 480-1. doi: 10.1227/01.NEU.0000290892.46954.12.
- Background Weir BK, Kongable GL, Kassell NF, Schultz JR, Truskowski LL, Sigrest A. Cigarette smoking as a cause of aneurysmal subarachnoid hemorrhage and risk for vasospasm: a report of the Cooperative Aneurysm Study. J Neurosurg. 1998 Sep;89(3):405-11. doi: 10.3171/jns.1998.89.3.0405.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nicotine | Unknown | 7 mg | Other |
| Comparator | Nicotine | Unknown | 14 mg | Other |
| Comparator | Nicotine | Unknown | 21 mg | Other |