Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia

Launched by SANGART · Mar 4, 2008

Keywords

ClinConnect Summary

Hemospan® is a novel hemoglobin-based oxygen carrier developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. Because of its molecular size and oxygen binding characteristics, Hemospan selectively off-loads oxygen in tissues predisposed to low oxygen tension. Preclinical evidence suggests that Hemospan provides volume expansion and enhances tissue perfusion. Hemospan is therefore being developed as an oxygen-carrying plasma expander for patients where tissues are at risk of inadequate perfusion and oxygenation.

In patients with chronic critical lower limb ischemia (CCLI)...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult male or female (surgically sterile or post-menopausal) patients with CCLI that meet the following definition: i) History of pain at rest and/or ulceration; ii) Ankle systolic BP/Brachial systolic BP Index (ABI) \<0.6 at the time of inclusion; iii) Ankle systolic BP \<70 mmHg and/or toe systolic BP \<50 mmHg
• • Has received written and verbal information about the investigational product and the protocol by the investigator and has had the opportunity to ask questions about the study
• • Patients must sign an Informed Consent Form (ICF), that has been reviewed and approved by the independent Ethics Committee (EC)
• Exclusion Criteria:
• • Severe congestive heart failure (EF \<40%, or New York Heart Association Class III or IV
• • Any acute or chronic condition that will limit the patient's ability to complete the study
• • Recent acute coronary syndrome (unstable angina or myocardial infarction \[MI\] within 1 month)
• • Severe dementia or clinically significant psychiatric disorder requiring active treatment
• • Evidence of untreated or uncontrolled hypertension (SBP \>180 mmHg, or DBP \>100 mmHg), or a difference in systolic BP in each arm that is \>15 mmHg (measured by cuff and a pen-Doppler at screening in the supine position, in both arms)
• • Smoking or use of any nicotine-containing product (e.g., snuff) within previous 24 hours before start of study
• • Any systemic rheumatic disease
• • Taking oral steroid therapy (does not include steroids taken intermittently via inhaler)
• • Chronic hepatic disease (abnormal LFTs \>3X upper limit of normal, known history of Hepatitis C or B)
• • Chronic renal disease (creatinine \>1.8 mg/dL, or known polycystic kidney disease)
• • Expectation of poor patient compliance with study protocol
• • Patients scheduled for surgical procedure within 7 days from start of this study
• • Involved in any investigational drug or device trial within 30 days prior to this study
• • Professional or ancillary personnel involved with this study