NCT00425334

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

2.3 years

First QC Date

January 18, 2007

Last Update Submit

August 15, 2013

Conditions

Blood Loss, SurgicalProstate CancerSurgery

Keywords

Blood lossIschemiaHemoglobinBlood SubstitutesPlasma Expanders

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    One month

Secondary Outcomes (7)

  • Changes in oxygenation, perfusion and cardiovascular status

    3 days

  • Number and type of cardiac rhythm disturbances

    3 days

  • Number and duration of intraoperative hypotensive episodes

    6 hours

  • Incidence of pharmacologic interventions for cardiovascular support

    3 days

  • Duration of supplemental oxygen use

    3 days

  • +2 more secondary outcomes

Study Arms (2)

Hemospan (MP4OX)

EXPERIMENTAL

4.3 g/dL MalPEG-Hb solution

Drug: Hemospan (MP4OX)

Control

ACTIVE COMPARATOR

Ringer's lactate

Drug: Ringer's lactate

Interventions

Hemospan (MP4OX)DRUG

250 mL or 500 mL Hemospan (MP4OX)

Also known as: MP4OX solution, 4.3 g/dL MalPEG Hb, PEGylated Hb
Hemospan (MP4OX)
Ringer's lactateDRUG

250 mL or 500 mL Ringer's lactate USP

Also known as: Lactated Ringers, Ringers solution, Hartmann's solution
Control

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Related Publications (6)

  • Bjorkholm M, Fagrell B, Przybelski R, Winslow N, Young M, Winslow RM. A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica. 2005 Apr;90(4):505-15.

    PMID: 15820947BACKGROUND

  • Young MA, Riddez L, Kjellstrom BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804. doi: 10.1097/01.ccm.0000172648.55309.13.

    PMID: 16096458BACKGROUND

  • Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. doi: 10.1182/blood-2006-02-005272. Epub 2006 Jul 20.

    PMID: 16857991BACKGROUND

  • Winslow RM. Current status of oxygen carriers ('blood substitutes'): 2006. Vox Sang. 2006 Aug;91(2):102-10. doi: 10.1111/j.1423-0410.2006.00789.x.

    PMID: 16907870BACKGROUND

  • Olofsson C, Ahl T, Johansson T, Larsson S, Nellgard P, Ponzer S, Fagrell B, Przybelski R, Keipert P, Winslow N, Winslow RM. A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology. 2006 Dec;105(6):1153-63. doi: 10.1097/00000542-200612000-00015.

    PMID: 17122578BACKGROUND

  • Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.

    PMID: 17198847BACKGROUND

Related Links

MeSH Terms

Conditions

Blood Loss, SurgicalProstatic NeoplasmsHemorrhageIschemia

Interventions

maleimide-polyethylene glycol-modified hemoglobin, MP4Ringer's LactateRinger's Solution

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative ComplicationsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • John Ulatowski, M.D., Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Peter E. Keipert, Ph.D.

    Sangart, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2007

First Posted

January 22, 2007

Study Start

July 1, 2005

Primary Completion

October 1, 2007

Study Completion

November 1, 2007

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

US(1)