Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2005-07-31
2007-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Hemospan (MP4OX)
4.3 g/dL MalPEG-Hb solution
Hemospan (MP4OX)
250 mL or 500 mL Hemospan (MP4OX)
Control
Ringer's lactate
Ringer's lactate
250 mL or 500 mL Ringer's lactate USP
Interventions
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Hemospan (MP4OX)
250 mL or 500 mL Hemospan (MP4OX)
Ringer's lactate
250 mL or 500 mL Ringer's lactate USP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Sangart
INDUSTRY
Responsible Party
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Principal Investigators
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John Ulatowski, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Peter E. Keipert, Ph.D.
Role: STUDY_DIRECTOR
Sangart, Inc.
Locations
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Johns Hopkins Medical Institutions
Baltimore, Maryland, United States
Countries
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References
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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.
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.
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.
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.
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.
Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.
Related Links
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Click here for more information about Sangart, Inc.
Other Identifiers
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6012
Identifier Type: -
Identifier Source: org_study_id