Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425334
Status:
COMPLETED
Last Update Posted:
2013-08-19
First Post:
2007-01-18
Brief Title:
Safety Study of Hemospan in Prostatectomy Patients
Sponsor:
Sangart
Organization:
Sangart
Study Overview
Official Title:
A Clinical Safety Phase II Increasing Dose Study of MP4 Hemospan in Total Prostatectomy Surgical Patients
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a progressive dose escalation study designed to evaluate the safety of Hemospan compared to a standard crystalloid solution Ringers 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
Detailed Description:
Donor allogeneic blood transfusions are often required during andor 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 Ringers 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
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 Ringers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None