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Pentaspan

Phase 2

Cardiac Surgery | Unknown | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Sep 18, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment240

FDA Designations

No designations recorded

Clinical trial landscape

Pentaspan · 1 trial · 1 indication

Phase 2 1
NCT00337805Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac SurgeryCardiac Surgery
COMPLETED240 Analytics
PHASE2COMPLETED
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
Cardiac SurgeryUnlock trial analytics

Study Endpoints

Primary Endpoints

Use of catecholamines at 8:00 the morning after surgery
first post operative day

Secondary Endpoints

Total use of catecholamines
Time in ICU
Time in the ICU
Time in ICU
Post-operative complications
Hospital stay or 28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1 colloidACTIVE_COMPARATORBoluses of fluids are a pentastarch (up to 1000 ml)
2. CrytalloidACTIVE_COMPARATORBoluses are given as normal saline

Interventions

NameTypeDescription
PentaspanOTHERWhen fluids are indicated either pentaspan or saline are given in a double blind randomized assignment
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * status post cardiac surgery * pulmonary artery occlusion catheter in place * informed consent * morning case (must be out of OR by 2:00 PM Exclusion Criteria: * excessive bleeding (\> 200 cc/hr) * intraaortic balloon pump * refusal by treating team * emergency cases * patien...

Countries:Canada
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Frequently asked questions about Pentaspan

What is Pentaspan used for in cardiac surgery?

Pentaspan is an investigational drug being studied for use in cardiac surgery. It is being evaluated as a resuscitation fluid after cardiac surgery, as part of a double-blind randomized trial comparing it to saline. The drug is in Phase 2 clinical development for this indication.

Who makes Pentaspan?

Pentaspan is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this drug for use in cardiac surgery, with the drug currently in Phase 2 development.

What phase is Pentaspan in?

Pentaspan is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for use in cardiac surgery, specifically for resuscitation after the procedure.

What clinical trials is Pentaspan in?

Pentaspan has one completed clinical trial registered under NCT00337805, titled "Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery." This Phase 2 trial enrolled 240 participants in Canada and was a randomized, double-blind, active-controlled study.

Is Pentaspan the same as saline?

No, Pentaspan is not the same as saline. In the clinical trial NCT00337805, Pentaspan was compared directly against saline for resuscitation after cardiac surgery. The trial was designed to evaluate the effects of Pentaspan relative to the saline control in this patient population.