NCT00301535

Brief Summary

The purpose of this study is to determine if Hemopure® will enhance tissue preservation during Cardiopulmonary Bypass surgery.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_2 coronary-artery-disease

Timeline
Completed

Started Feb 2006

Typical duration for phase_2 coronary-artery-disease

Geographic Reach
3 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

May 16, 2008

Status Verified

May 1, 2008

Enrollment Period

2.4 years

First QC Date

March 9, 2006

Last Update Submit

May 15, 2008

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Bypass Graftmemory loss after cardiac surgeryside effects of bypass

Outcome Measures

Primary Outcomes (1)

  • Rate of peak CK-MB elevation ≥ 5X upper limit of normal

    Baseline; Peri-op; Days 1,2,3 post procedure; Discharge or Day 6 post procedure(whichever is earlier)

Secondary Outcomes (1)

  • MACE @ discharge and 30 days post surgery; Change in renal function; Renal failure; Increased Cardiac Troponin T; Death rate; MI/stroke; Supplemental RBC transfusions; Total units RBC and HBOC-201; Intra Aortic Balloon Pump use, pump time; New onset CHF

    Duration of the study

Study Arms (2)

1

EXPERIMENTAL
Drug: HBOC-201 (hemoglobin glutamer-250 bovine)

2

NO INTERVENTION

Interventions

HBOC-201 (hemoglobin glutamer-250 bovine)DRUG

HBOC-201 is an investigational solution of purified, glutaraldehyde-polymerized bovine hemoglobin with a concentration of hemoglobin of 13 ± 1 g/dL

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is between the ages of 18 and 80.
  • Subject is an acceptable candidate for CABG.
  • Subject is scheduled for CABG (without planned valvular repair or replacement) by cardiopulmonary bypass.
  • Subject signs informed consent
  • Subject and the treating physician agree that subject can comply with all study procedures and follow-up visit at time of subject screening.

You may not qualify if:

  • Pre-operative myocardial infarction, defined as CK-MB level \> 2 times upper limit of normal 24 hours prior to CABG surgery.
  • Renal failure defined as serum creatinine greater 220 µmol/L
  • Subject has an ejection fraction ≤ 30% (as measured by Echocardiography within 30 days of study enrollment).
  • Active infection.
  • History of prior stroke within last six months or history of prior stroke with residual neurological deficit.
  • Transient Ischemic attack within last 6 months.
  • Subject has a history of coagulopathy.
  • Subject is pregnant or currently breastfeeding.
  • History of allergy to beef products.
  • Pre-operative cardiogenic shock defined as cardiac index ≤ 1.8.L/min/m2 despite the use of vasopressors.
  • Underlying medical conditions that would limit subject's life expectancy to less than 12 months.
  • Severe pulmonary disease \[based upon clinical diagnosis or pulmonary function tests (FEV \<1 liter), if available\] that may interfere with weaning subject from ventilator.
  • History of acute central nervous disorder (e.g., seizure or traumatic injury).
  • Severe hypertension (≥ 160/90 mm Hg) that cannot be medically controlled despite treatment with two antihypertensive therapies.
  • Severe liver dysfunction as defined by total bilirubin ≥ 51 µmol/L or 2 times the site normal limit of AST or ALT activity.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Thessaloniki Heart Institute - St. Luke's Hospital

Thessaloniki, 552 36, Greece

RECRUITING

Milpark Hospital

Johannesburg, South Africa

RECRUITING

Oxford Heart Centre - John Radcliffe Hospital

Headington, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

HBOC 201

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • A. Gerson Greenburg, MD, Ph.D

    Biopure Corporation

    STUDY DIRECTOR

Central Study Contacts

Tiana Gorham

CONTACT

tgorham@biopure.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 9, 2006

First Posted

March 13, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2008

Study Completion

September 1, 2008

Last Updated

May 16, 2008

Record last verified: 2008-05

Locations

GR(1)ZA(1)GB(1)