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CompletedNCT00633659Updated Aug 19, 2013

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

A Phase 2 interventional study of Hemospan (MP4OX) and Voluven (HES 130/0.4) in Vascular Disease and Critical Lower Limb Ischemia, sponsored by Sangart. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2013-08-19.

Sponsored by Sangart · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

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), the primary cause of ischemic symptoms in the leg is insufficient perfusion. As many of the patients suffering from CCLI are elderly and have concomitant disease, surgical procedures may not always be possible. The goal of all treatments is to improve the blood flow in the nutritional vessels of the ischemic areas; one such possibility may be to use an oxygen-carrying plasma expander.

Hemospan has been shown to improve the oxygenation of tissues by preserving functional capillary density. In addition, Hemospan has a high affinity for oxygen - a feature that is specifically designed to target the unloading of oxygen in the microcirculation where local PO2 levels are much lower (e.g., in ischemic regions). Since Hemospan is a cell-free oxygen carrier, it should be able to perfuse capillaries that are so constricted that red blood cells are unable to flow through them.

02

Conditions studied

  • Vascular Disease
  • Critical Lower Limb Ischemia

Keywords

  • Hemospan
  • Oxygen carriers
  • Blood substitutes
  • Ischemia
  • Tissue oxygenation
03

In context

Vascular Diseases

1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.

This study's enrollment of 6 is below the median of 78 across 639 interventional studies indexed under Vascular Diseases.

Browse Vascular Diseases studies →

Lead sponsor

Sangart is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Hemospan (MP4OX)

    4.3 g/dL MalPEG-Hb solution

    Drug: Hemospan (MP4OX)

  • Experimental
    Control

    Voluven (HES 130/0.4)

    Drug: Voluven (HES 130/0.4)

Interventions

  • DrugHemospan (MP4OX)

    250 mL of Hemospan (MP4OX)

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

  • DrugVoluven (HES 130/0.4)

    250 mL of Voluven (HES 130/0.4) solution

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

06

What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: 4 hours

07

Study locations

1 site
  • Karolinska Universitetssjukhuset
    Stockholm, Sweden
08

References and documents

Publications

  • 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. PubMed 15820947 ↗
  • 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. PubMed 17122578 ↗
  • 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. PubMed 18279190 ↗
  • Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013. PubMed 17198847 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00633659
Lead sponsor
Sangart
Responsible party
Sponsor
First posted
Mar 12, 2008
Start date
Sep 2007
Primary completion
Jun 2008
Completion
Dec 2008
Last update
Aug 19, 2013

Study contacts

Pär Olofsson, MD, PhD
principal investigator · Karolinska University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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