search
Back to results

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

Primary Purpose

Vascular Disease, Critical Lower Limb Ischemia

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Hemospan (MP4OX)
Voluven (HES 130/0.4)
Sponsored by
Sangart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Disease focused on measuring Hemospan, Oxygen carriers, Blood substitutes, Ischemia, Tissue oxygenation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Universitetssjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hemospan (MP4OX)

Control

Arm Description

4.3 g/dL MalPEG-Hb solution

Voluven (HES 130/0.4)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2008
Last Updated
August 15, 2013
Sponsor
Sangart
search

1. Study Identification

Unique Protocol Identification Number
NCT00633659
Brief Title
Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia
Official Title
A Phase II Study of Hemospan® Versus Voluven® to Evaluate Vascular Resistance and Forearm Blood Flow, and to Assess Local Skin Blood Flow and Tissue Oxygenation in the Ischemic Foot of Patients With Chronic Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sangart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease, Critical Lower Limb Ischemia
Keywords
Hemospan, Oxygen carriers, Blood substitutes, Ischemia, Tissue oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemospan (MP4OX)
Arm Type
Experimental
Arm Description
4.3 g/dL MalPEG-Hb solution
Arm Title
Control
Arm Type
Experimental
Arm Description
Voluven (HES 130/0.4)
Intervention Type
Drug
Intervention Name(s)
Hemospan (MP4OX)
Other Intervention Name(s)
MP4OX solution, 4.3 g/dL MalPEG-Hb, PEGylated Hb
Intervention Description
250 mL of Hemospan (MP4OX)
Intervention Type
Drug
Intervention Name(s)
Voluven (HES 130/0.4)
Other Intervention Name(s)
6% hetastarch solution, 6% HES 130/0.4
Intervention Description
250 mL of Voluven (HES 130/0.4) solution
Primary Outcome Measure Information:
Title
To investigate the effect of Hemospan on vascular resistance by evaluating blood flow in the forearm
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pär Olofsson, MD, PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Universitetssjukhuset
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
15820947
Citation
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.
Results Reference
background
PubMed Identifier
17122578
Citation
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.
Results Reference
background
PubMed Identifier
18279190
Citation
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.
Results Reference
background
PubMed Identifier
17198847
Citation
Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs