CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Hemospan (MP4OX) +1 moredrug
Likely dose
Hemospan (MP4OX) 250 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00425334
NCT00425334Phase 2Completed
CompareCT.gov

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

Sangart·interventional·Posted Jan 22, 2007·Updated Aug 19, 2013

In Brief

A Phase 2 clinical trial evaluating Hemospan (MP4OX) and Ringer's lactate for Blood Loss, Surgical and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Loss, Surgical, Prostate Cancer, Surgery
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 22, 2007
Enrollment StartJul 1, 2005
Primary CompletionOct 1, 2007
Study CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.4 years ago

Interventions

Hemospan (MP4OX)drug

250 mL or 500 mL Hemospan (MP4OX)

Ringer's lactatedrug

250 mL or 500 mL Ringer's lactate USP