A Phase Ib/II in Patients With Acute Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Stroke is the fifth leading cause of death in the United States and is the leading cause of
      long term disability. Distinct geographic disparities in stroke mortality, with highest rates
      in the southeast United States including Arkansas, are known as the "stroke belt." There the
      average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke is the
      leading cause of serious long-term disability. Between 2012 and 2030, disability and medical
      costs related to stroke are projected to triple, from $71.6 billion to $184.1 billion, with
      the majority of the projected increase in costs arising from those 65 to 79 years of age.

      There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in
      85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion
      of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue
      plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood
      vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it
      reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond
      the effective time window for therapy is a common reason for failure.

      To reduce the devastating impact of stroke on individuals and society, the investigators
      continue to seek ways to improve functional recovery and limit ischemic damage in stroke
      patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has
      recently shown strong positive effects in pre-clinical animal models of acute ischemic
      stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants
      and blood substitutes yet none have been successful.
    


Intervention name(s): 0.05 mL/kg DDFPe; 0.05 mL/kg Placebo; 0.10 mL/kg DDFPe; 0.10 mL/kg Placebo; 0.17 mL/kg DDFPe; 0.17 mL/kg Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg).; Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg).; Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg).; Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg).; Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg).; Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg).
Other intervention name(s): Dodecafluoropentane emulsion (DDFPe), NanO2TM; Dodecafluoropentane emulsion (DDFPe), NanO2TM; Dodecafluoropentane emulsion (DDFPe), NanO2TM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment