Safety Study of Hemospan® in Prostatectomy Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00425334
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : August 19, 2013
Information provided by (Responsible Party):

Brief Summary:
This is a progressive dose escalation study designed to evaluate the safety of Hemospan compared to a standard crystalloid solution (Ringer's lactate) in elective surgery patients undergoing total prostatectomy procedures with anticipated blood loss of more than 500 mL. Secondary objectives of this study are to observe possible activity of Hemospan for tissue oxygenation, perfusion and cardiovascular support.

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Prostate Cancer Surgery Drug: Hemospan (MP4OX) Drug: Ringer's lactate Phase 2

Detailed Description:

Donor (allogeneic) blood transfusions are often required during and/or after elective surgery to maintain adequate hemoglobin concentration, prevent tissue ischemia (inadequate perfusion), treat hypotension (low blood pressure), and compensate for fluid shifts. Hemospan is a novel hemoglobin-based oxygen carrier and plasma expander specifically developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia (insufficient oxygenation). As a result of the molecular size and oxygen dissociation characteristics, Hemospan selectively off-loads oxygen in tissues predisposed to low oxygen tension.

In preclinical studies Hemospan has been found to be free of significant toxicity in a variety of animal species. These studies have also demonstrated that Hemospan may be ideally suited for this application, and may even perform better than blood in certain situations. Hemospan has been evaluated in three clinical studies, including a 90-patient multi-center Phase II orthopedic surgery trial completed in Sweden in 2005. No serious adverse events attributable to Hemospan have been noted in any of these trials.

Sangart is developing Hemospan as an oxygen-carrying plasma expander and hemodiluent for patients undergoing elective surgical procedures. In the current Phase II study in prostatectomy patients, the administration of Hemospan (Treatment) or Ringer's lactate (Controls) occurs after approximately 250 mL of surgical blood loss has occurred. Study evaluations include clinical observations, subjective symptoms, vital signs, ECG, pulmonary hemodynamics (by TEE), serum chemistry, hematology, urinalysis, renal function, and oxygenation measurements, as well as a safety follow-up assessment at 4-6 weeks after surgery. An independent Data Safety Monitoring Board (DSMB) will review the safety data following completion of each dosing cohort.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Clinical Safety (Phase II) Increasing Dose Study of MP4 (Hemospan®) in Total Prostatectomy Surgical Patients
Study Start Date : July 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hemospan (MP4OX)
4.3 g/dL MalPEG-Hb solution
Drug: Hemospan (MP4OX)
250 mL or 500 mL Hemospan (MP4OX)
Other Names:
  • MP4OX solution
  • 4.3 g/dL MalPEG Hb
  • PEGylated Hb

Active Comparator: Control
Ringer's lactate
Drug: Ringer's lactate
250 mL or 500 mL Ringer's lactate USP
Other Names:
  • Lactated Ringers
  • Ringers solution
  • Hartmann's solution

Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: One month ]

Secondary Outcome Measures :
  1. Changes in oxygenation, perfusion and cardiovascular status [ Time Frame: 3 days ]
  2. Number and type of cardiac rhythm disturbances [ Time Frame: 3 days ]
  3. Number and duration of intraoperative hypotensive episodes [ Time Frame: 6 hours ]
  4. Incidence of pharmacologic interventions for cardiovascular support [ Time Frame: 3 days ]
  5. Duration of supplemental oxygen use [ Time Frame: 3 days ]
  6. Volume of intravenous fluid administered [ Time Frame: 3 days ]
  7. Blood products administered [ Time Frame: 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult male ASA class I or II patients over the age of 18 scheduled for elective total prostatectomy surgery with anticipated blood loss greater than 500 mL
  • Patients must be in good health (other than the indication for prostatectomy surgery) as determined by medical history, physical examination, clinical laboratory studies and electrocardiogram (ECG)
  • At screening (within 2 weeks of the scheduled surgery) the blood chemistry and hematology (Hb, Hct, RBC, WBC, platelets, PT, PTT, plasma fibrinogen, fibrin split products and haptoglobin) must be within the laboratory normal limits
  • Patients must test negative for HIV and hepatitis screens
  • Patients must sign an Informed Consent Form (see Appendix II) for the study, which has been reviewed and approved by the Institutional Review Board, prior to screening and entry into the study
  • Patients must be available within the continental United States for the period of this study, and willing to complete the follow-up at 4-6 weeks
  • Patients must be able to understand and read English

Exclusion Criteria:

  • Any acute or chronic condition which would limit the patient's ability to complete the study or jeopardize the safety of the patient
  • History or clinical manifestations of a significant cardiovascular or pulmonary disorder
  • Clinically significant psychiatric disorder requiring active treatment
  • History of diabetes requiring active treatment
  • History or clinical manifestation of significant renal or hepatic disorder
  • History of thyroid disease or clinical symptoms consistent with thyroid disease
  • History of bleeding disorder
  • History or family history of a hemoglobinopathy
  • Patients with contraindications to TEE probe insertion
  • Patients who have received any other investigational drugs within 30 days prior to administration of the study drug
  • Professional or ancillary personnel involved with this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00425334

United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Principal Investigator: John Ulatowski, M.D., Ph.D. Johns Hopkins University
Study Director: Peter E. Keipert, Ph.D. Sangart, Inc.

Additional Information:
Responsible Party: Sangart Identifier: NCT00425334     History of Changes
Other Study ID Numbers: 6012
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013

Keywords provided by Sangart:
Blood loss
Blood Substitutes
Plasma Expanders

Additional relevant MeSH terms:
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Pharmaceutical Solutions