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

Sponsored by:	Biopure Corporation
Information provided by:	Biopure Corporation
ClinicalTrials.gov Identifier:	NCT00300040

Purpose

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.

Condition	Intervention	Phase
Peripheral Vascular Disease	Drug: Hemoglobin glutamer 250 - bovine Drug: 6% Hydroxyethylstarch	Phase II

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Hetastarch

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II, Multi-Center,Single-Blind,Placebo-Controlled Study,Evaluating Safety & Feasibility of HBOC-201 (Wound Healing Patients With Peripheral Vascular Disease & Undergoing Lower Limb Amputation Due to Critical Lower Limb Ischemia

Further study details as provided by Biopure Corporation:

Primary Outcome Measures:

Mortality at 60 days post amputation procedure [ Time Frame: 60(±7 days) post-procedure follow-up visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: 15(±3 days) , 30(±7 days) and 60(±7 days) post-procedure follow-up visits ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	May 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Hemoglobin glutamer 250 - bovine	Drug: Hemoglobin glutamer 250 - bovine intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)
2: Active Comparator 6% Hydroxyethylstarch	Drug: 6% Hydroxyethylstarch 250ml for intravenous infusion

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%).

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300040

Locations

South Africa
University of Stellenbosch
Tygerburg, South Africa, 7506
South Africa, Guateng
Johannesburg Hospital
Johannesburg, Guateng, South Africa, 2041
Pretoria Academic Hospital
Pretoria, Guateng, South Africa, 0001
Milpark Hospital
Parktown West, Guateng, South Africa, 2193
United Kingdom, Oxfordshire
John Radcliffe Hospital
Headington, Oxfordshire, United Kingdom, OX3 9DU

Sponsors and Collaborators

Biopure Corporation

Investigators

Study Director:

A. Gerson Greenburg, MD, Ph.D.

Biopure Corporation

More Information

Responsible Party:	Biopure ( Biopure )
Study ID Numbers:	BIOSA001/BIOEU001
Study First Received:	March 6, 2006
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00300040
Health Authority:	South Africa: Medicines Control Council; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biopure Corporation:

Amputation
Lower limb
Critical Limb Ischemia
residual limb

Peripheral Vascular Disease
re-amputation
Lower Limb Ischemia
PVD

Study placed in the following topic categories:

Peripheral Vascular Diseases
Vascular Diseases
HBOC 201
Hetastarch
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Hematologic Agents

Blood Substitutes
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009