A Clinical Study of Lyophilized Plasma in Patients on War... | NCT01541098

Studies
A Clinical Study of Lyophilized Plasma in Patients on Warfarin

NCT01541098

Sponsor

HemCon Medical Technologies, Inc

Status

Withdrawn

Last Update Posted

Mar 18, 2015Estimated

Enrollment

0Actual

Phase

Phase 2

Conditions

Anticoagulant Therapy

Interventions

Lyophilized Plasma
Licensed Plasma

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Feb 16, 2012

First Submission Date that Met QC Criteria

Feb 28, 2012

First Posted Date

Feb 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 17, 2015

Last Update Posted Date

Mar 18, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a multi center, phase 2 randomized controlled study to determine the effect of lyophilized plasma in patients on warfarin therapy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Licensed Plasma	Active Comparator		Biological: Licensed Plasma
Lyophilized Plasma	Experimental		Biological: Lyophilized Plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lyophilized Plasma	Biological	Licensed plasma that has been lyophilized.	Lyophilized Plasma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess and Compare Adverse Events	The primary safety objective is to assess the adverse events after infusion of lyophilized plasma compared to control.	Duration of Study (Less than or equal to 72 hours)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patients receiving oral anticoagulation with warfarin derived agents.
Patients who have need for urgent surgery, an invasive procedure or identification of a patient with active bleeding where oral or parenteral vitamin K therapy is deemed too slow in its action for reversal of warfarin anticoagulant effects.
Patients with an elevated international normalized ratio.

Exclusion Criteria

Patients who are clinically unstable.
Patients who have congenital or acquired coagulopathies (other than warfarin therapy).
Patients who have received medications that could interfere with the results of laboratory testing.
Pregnant or nursing women.
Patients participating in another clinical treatment study currently or during the past 1 month prior to study inclusion.
Patients previously enrolled in this study.
Active illicit drug use.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided