Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia

NCT00300040 | Terminated Phase 2

• 1 other identifier: BIOSA001/BIOEU001
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation. The hypothesis is that HBOC-201 will pass through the partially occluded lesions in the peripheral arteries in the lower extremity and promote the wound healing process by delivering oxygen to the oxygen deprived tissues. This will reduce the incidence of lower limb wound complications at 60 days post-surgery and may reduce the incidence of a second amputation.

Conditions

Peripheral Vascular Disease

Keywords

Amputation; Lower limb; Critical Limb Ischemia; residual limb; Peripheral Vascular Disease; re-amputation; Lower Limb Ischemia; PVD

Outcome Measures

Primary Outcomes (1)

• Mortality at 60 days post amputation procedure

  60(±7 days) post-procedure follow-up visit

Secondary Outcomes (1)

• 30 day follow up mortality; Complete wound healing 30, 60 day follow up; Time to complete wound healing; Re-amputation 60 days; Hospital, ICU & rehab days; TcPO2 change; Quality of Life; Delayed wound healing/complications; Rehospitalization; Surgeries

  15(±3 days) , 30(±7 days) and 60(±7 days) post-procedure follow-up visits

Study Arms (2)

1

EXPERIMENTAL

Hemoglobin glutamer 250 - bovine

Drug: Hemoglobin glutamer 250 - bovine

2

ACTIVE COMPARATOR

6% Hydroxyethylstarch

Drug: 6% Hydroxyethylstarch

Interventions

Hemoglobin glutamer 250 - bovine DRUG

intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)

Also known as: Hemopure, HBOC-201

1

6% Hydroxyethylstarch DRUG

250ml for intravenous infusion

Also known as: HAES-steril®

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥ 18 ≤ 75 years of age
• Scheduled amputation at or above ankle joint, or a more proximal location but below or through the knee joint
• Documented severe lower extremity peripheral artery occlusive disease confirmed by clinical symptoms of critical limb ischemia and:
• Frankly gangrenous tissue that merits amputation or
• Angiographic evidence of occlusive peripheral artery disease within one month of screening
• Participant or legal representative signs informed consent
• Willingness to follow study instructions and follow-up visits

You may not qualify if:

• No informed consent is obtained
• If medically inappropriate to administer 250 mL colloidal solution daily for 4 consecutive days
• Uncontrolled hypertension (BP \> 160/90 mm Hg) despite 2 antihypertensive meds or BP \> 180/100 mm Hg if untreated
• Severe liver dysfunction defined by Total Bilirubin \> 3 mg/dL or twice the normal limit of serum AST or ALT
• Symptomatic CVD diagnosed w/ in last 6 months or known high grade carotid stenosis
• Any severe or unstable medical condition that might interfere w/ the evaluation of study medication
• Cardiogenic shock (cardiac index \< 2 L/min/m2, PCWP \> 18 mm Hg)
• Amputation above knee joint or below ankle joint
• Any amputation whereby primary skin closure not technically feasible
• Candidate for percutaneous or surgical revascularization
• Cardiac failure defined by a NY class III/IV or left ventricular ejection fraction \< 30%
• Life expectancy \< 60 days
• Systemic mastocytosis
• Previously demonstrated beef product allergy
• Myocardial infarction w/ in 30 days

Sponsors & Collaborators

• Biopure Corporation: lead

Study Sites (5)

Johannesburg Hospital

Johannesburg, Guateng, 2041, South Africa

Location

Milpark Hospital

Parktown West, Guateng, 2193, South Africa

Location

Pretoria Academic Hospital

Pretoria, Guateng, 0001, South Africa

Location

University of Stellenbosch

Tygerburg, 7506, South Africa

Location

John Radcliffe Hospital

Headington, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Interventions

HBOC 201; Hydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Officials

• A. Gerson Greenburg, MD, Ph.D.

  Biopure Corporation

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2006
• First Posted: March 8, 2006
• Study Start: May 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 16, 2008

Record last verified: 2008-05

Locations

ZA (4); GB (1)