Response of Continuous Recombinant Antithrombin Infusion... | NCT03090893

Studies
Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients

NCT03090893

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Sep 10, 2018Actual

Enrollment

0Actual

Phase

Early Phase 1

Conditions

Antithrombin Deficiency Type 2

Interventions

ATryn continuous infusion

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

Sep 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI passed away

Expanded Access Info

Start Date

Jun 1, 2018Estimated

Primary Completion Date

Jun 2019Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Mar 21, 2017

First Submission Date that Met QC Criteria

Mar 21, 2017

First Posted Date

Mar 27, 2017Actual

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

Sep 6, 2018

Last Update Posted Date

Sep 10, 2018Actual

Name	Class
rEVO Biologics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.

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

Early Phase 1

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
Infusion group	Experimental	Subjects will receive ATryn continuous infusion for maintaining serum antithrombin III levels between 80 - 100	Drug: ATryn continuous infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATryn continuous infusion	Drug	replenish serum thrombin levels	Infusion group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of time within the serum AT level target range of 80-100%	Target value of Antithrombin is recorded as %	72 hour infusion period

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completed cardiac surgery with Cardiopulmonary Bypass and subsequently placed on venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) support at any point during the ongoing hospitalization
Serum Antithrombin < 60%.

Exclusion Criteria:

Heart transplantation during ongoing hospitalization
Excessive bleeding (300 ml/hr of chest tube drainage for 2 consecutive hours)
Weight < 40 kg
Allergy to goat products
Anticoagulation with a direct thrombin inhibitor
Religious exception to blood products
Hypothermia (< 34°C)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
William C. Oliver, Jr., MD	Mayo Clinic	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

will not share individual patient data

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C537779	Antithrombin deficiency type 2

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided