title: Phase I clinical trial for the feasibility and safety of remote ischemic conditioning for aneurysmal subarachnoid hemorrhage.
abstract: BACKGROUND
  Remote ischemic conditioning (RIC) is a powerful endogenous mechanism whereby a sublethal ischemic stimulus confers a protective benefit against a subsequent severe ischemic insult. RIC has significant potential clinical implications for the prevention of delayed ischemic neurological deficit after aneurysmal subarachnoid hemorrhage (aSAH). Although RIC has been extensively investigated in animal models, it has not been fully evaluated in humans.
  
  
  OBJECTIVE
  To assess the feasibility and safety of RIC for aSAH in a phase I clinical trial.
  
  
  METHODS
  Consecutive patients hospitalized for treatment of an aSAH who met the inclusion/exclusion criteria were approached for consent. Enrolled patients received up to 4 RIC sessions on nonconsecutive days. Primary end points were the development of a symptomatic deep venous thrombosis, bruising, or injury to the limb and request to stop by the patient or surrogate. The secondary end points were the development of new neurological deficits or cerebral infarct, demonstrated by brain imaging after enrollment, and neurological deficit and condition at follow-up.
  
  
  RESULTS
  Twenty patients were enrolled and underwent 76 RIC sessions, 75 of which were completed successfully. One session was discontinued when the patient became confused. No patient developed a deep venous thrombosis or injury to the preconditioned limb. No patient developed delayed ischemic neurological deficit during enrollment. At follow-up, median modified Rankin Scale score was 1 and Glasgow Outcome Scale score was 5.
  
  
  CONCLUSIONS
  The RIC procedure was well tolerated and did not cause any injury. RIC for aSAH warrants investigation in a subsequent pivotal clinical trial.
authors: Department of Neurosurgery, David Geffen School of Medicine at the University of California, Los Angeles, California.
authors: Nestor R
authors: NR
authors: Gonzalez
authors: Mark
authors: M
authors: Connolly
authors: Joshua R
authors: JR
authors: Dusick
authors: Harshal
authors: H
authors: Bhakta
authors: Paul
authors: P
authors: Vespa
mesh_terms: D000328:Adult; D000368:Aged; D001921:Brain / Q000098:blood supply*; D005240:Feasibility Studies; D005260:Female; D023261:Glasgow Outcome Scale; D006801:Humans; D019194:Ischemic Preconditioning / Q000009:adverse effects / Q000379:methods*; D008297:Male; D008875:Middle Aged; D013345:Subarachnoid Hemorrhage / Q000150:complications / Q000628:therapy*; D055815:Young Adult