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

NCT ID: NCT00300040

Last Updated: 2008-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-06-30

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.

Detailed Description

This is a Phase II, single-blinded, prospectively randomized, parallel-group, placebo controlled study that will evaluate the safety and feasibility of HBOC-201 when administered therapeutically to patients with a peripheral vascular occlusive disorder and who are undergoing lower limb amputation due to critical lower limb ischemia. Subjects will be randomized (1:1) to receive either HBOC-201 or a colloid control (HAES-steril® 6%).

Conditions

Peripheral Vascular Disease

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Hemoglobin glutamer 250 - bovine

Group Type: EXPERIMENTAL

Hemoglobin glutamer 250 - bovine

Intervention Type: DRUG

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

2

6% Hydroxyethylstarch

Group Type: ACTIVE_COMPARATOR

6% Hydroxyethylstarch

Intervention Type: DRUG

250ml for intravenous infusion

Interventions

Hemoglobin glutamer 250 - bovine

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

Intervention Type: DRUG

6% Hydroxyethylstarch

250ml for intravenous infusion

Intervention Type: DRUG

Other Intervention Names

Hemopure; HBOC-201; HAES-steril®

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Participation in another trial w/ in last 30 days
• Woman who is pregnant or breastfeeding
• Amputation with known infection at site of skin closure
• Renal dysfunction requiring dialysis, or serum creatinine level 2.5 mg/dL
• Peripheral vascular occlusion from cardio arterial emboli
• Uncontrolled diabetes blood glucose ≥ 400 mg/dL

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biopure Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Biopure

Principal Investigators

A. Gerson Greenburg, MD, Ph.D.

Role: STUDY_DIRECTOR

Biopure Corporation

Locations

Johannesburg Hospital

Johannesburg, Guateng, South Africa

Milpark Hospital

Parktown West, Guateng, South Africa

Pretoria Academic Hospital

Pretoria, Guateng, South Africa

University of Stellenbosch

Tygerburg, , South Africa

John Radcliffe Hospital

Headington, Oxfordshire, United Kingdom

Countries

South Africa; United Kingdom

Other Identifiers

BIOSA001/BIOEU001

Identifier Type: -

Identifier Source: org_study_id