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Blood Loss, SurgicalPhase 2NCT00425334

Safety Study of Hemospan® in Prostatectomy Patients

A Phase 2 study testing Hemospan (MP4OX) and Ringer's lactate in people with Blood Loss, Surgical and Prostate Cancer, run by Sangart at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Blood Loss, Surgical, Prostate Cancer, Surgery
What is being tested?
Hemospan (MP4OX) and Ringer's lactate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2005to Nov 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Medical Institutions

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Clinical Safety (Phase II) Increasing Dose Study of MP4 (Hemospan®) in Total Prostatectomy Surgical Patients

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.

Read the 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.

Being tested
Hemospan (MP4OX), Ringer's lactate
Keywords
Blood loss, Ischemia, Hemoglobin, Blood Substitutes, Plasma Expanders
Medical subject headings
Blood Loss, Surgical, Prostatic Neoplasms, Hemorrhage, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hemospan (MP4OX)Drug

    Also called MP4OX solution, 4.3 g/dL MalPEG Hb, PEGylated Hb

    250 mL or 500 mL Hemospan (MP4OX)

  • Ringer's lactateDrug

    Also called Lactated Ringers, Ringers solution, Hartmann's solution

    250 mL or 500 mL Ringer's lactate USP

Study groups in NCT00425334
Study groupRoleWhat they receive
Hemospan (MP4OX)Experimental4.3 g/dL MalPEG-Hb solution
Receives: Drug: Hemospan (MP4OX)
ControlActive comparatorRinger's lactate
Receives: Drug: Ringer's lactate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Measured: One month

Secondary outcomes (7)

  1. Changes in oxygenation, perfusion and cardiovascular status

    Measured: 3 days

  2. Number and type of cardiac rhythm disturbances

    Measured: 3 days

  3. Number and duration of intraoperative hypotensive episodes

    Measured: 6 hours

  4. Incidence of pharmacologic interventions for cardiovascular support

    Measured: 3 days

  5. Duration of supplemental oxygen use

    Measured: 3 days

  6. Volume of intravenous fluid administered

    Measured: 3 days

  7. Blood products administered

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2007 (estimated)
  2. Study startJul 2005
  3. Primary completionOct 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00425334
Sponsor's protocol ID
6012
Status last verified
Aug 2013
First submitted
18 Jan 2007
Last updated
19 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15820947

  • 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.

    PubMed 16096458

  • 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.

    PubMed 16857991

  • 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.

    PubMed 16907870

  • 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.

    PubMed 17122578

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

    PubMed 17198847

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hemospan (MP4OX) and Ringer's lactate in people with Blood Loss, Surgical and Prostate Cancer, run by Sangart at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: One month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00425334, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2013.

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