Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
This study has been terminated.
(Very slow enrollment.Study entry criteria not in line w/local standards of care)
Sponsor:
Biopure Corporation
Information provided by:
Biopure Corporation
ClinicalTrials.gov Identifier:
NCT00300040
First received: March 6, 2006
Last updated: May 15, 2008
Last verified: May 2008
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
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 |
|---|---|
|
Experimental: 1
Hemoglobin glutamer 250 - bovine
|
Drug: Hemoglobin glutamer 250 - bovine
intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)
Other Names:
|
|
Active Comparator: 2
6% Hydroxyethylstarch
|
Drug: 6% Hydroxyethylstarch
250ml for intravenous infusion
Other Name: HAES-steril®
|
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 | |
| Johannesburg Hospital | |
| Johannesburg, Guateng, South Africa, 2041 | |
| Milpark Hospital | |
| Parktown West, Guateng, South Africa, 2193 | |
| Pretoria Academic Hospital | |
| Pretoria, Guateng, South Africa, 0001 | |
| University of Stellenbosch | |
| Tygerburg, South Africa, 7506 | |
| United Kingdom | |
| 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
No publications provided
| Responsible Party: | Biopure |
| ClinicalTrials.gov Identifier: | NCT00300040 History of Changes |
| Other Study ID Numbers: | BIOSA001/BIOEU001 |
| Study First Received: | March 6, 2006 |
| Last Updated: | May 15, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Ischemia Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Pathologic Processes Cardiovascular Diseases Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Hetastarch HBOC 201 Plasma Substitutes Blood Substitutes Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013