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

NCT00633659 | Completed Phase 2

• 1 other identifier: 6034
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of Hemospan infusion on vascular reactivity, regional perfusion and oxygenation of ischemic tissue in patients with chronic critical lower limb ischemia.

Conditions

Vascular Disease; Critical Lower Limb Ischemia

Keywords

Hemospan; Oxygen carriers; Blood substitutes; Ischemia; Tissue oxygenation

Outcome Measures

Primary Outcomes (1)

• To investigate the effect of Hemospan on vascular resistance by evaluating blood flow in the forearm

  4 hours

Secondary Outcomes (1)

• To evaluate the effects of Hemospan on local skin blood flow and tissue oxygenation in an ischemic region of the foot

  4 hours

Study Arms (2)

Hemospan (MP4OX)

EXPERIMENTAL

4.3 g/dL MalPEG-Hb solution

Drug: Hemospan (MP4OX)

Control

EXPERIMENTAL

Voluven (HES 130/0.4)

Drug: Voluven (HES 130/0.4)

Interventions

Hemospan (MP4OX) DRUG

250 mL of Hemospan (MP4OX)

Also known as: MP4OX solution, 4.3 g/dL MalPEG-Hb, PEGylated Hb

Hemospan (MP4OX)

Voluven (HES 130/0.4) DRUG

250 mL of Voluven (HES 130/0.4) solution

Also known as: 6% hetastarch solution, 6% HES 130/0.4

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sangart: lead

Study Sites (1)

Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

Related Publications (4)

• Bjorkholm M, Fagrell B, Przybelski R, Winslow N, Young M, Winslow RM. A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica. 2005 Apr;90(4):505-15.

  PMID: 15820947 BACKGROUND

• Olofsson C, Ahl T, Johansson T, Larsson S, Nellgard P, Ponzer S, Fagrell B, Przybelski R, Keipert P, Winslow N, Winslow RM. A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology. 2006 Dec;105(6):1153-63. doi: 10.1097/00000542-200612000-00015.

  PMID: 17122578 BACKGROUND

• Olofsson C, Nygards EB, Ponzer S, Fagrell B, Przybelski R, Keipert PE, Winslow N, Winslow RM. A randomized, single-blind, increasing dose safety trial of an oxygen-carrying plasma expander (Hemospan) administered to orthopaedic surgery patients with spinal anaesthesia. Transfus Med. 2008 Feb;18(1):28-39. doi: 10.1111/j.1365-3148.2007.00811.x.

  PMID: 18279190 BACKGROUND

• Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.

  PMID: 17198847 BACKGROUND

Related Links

• For more information about Sangart, Inc.

MeSH Terms

Conditions

Vascular Diseases; Ischemia

Interventions

maleimide-polyethylene glycol-modified hemoglobin, MP4; HES 130-0.4; Hydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Officials

• Pär Olofsson, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

SE (1)