Study of the Glycocalyx in Abdominal Aortic Aneurysm | NCT01834092

Studies
Study of the Glycocalyx in Abdominal Aortic Aneurysm

NCT01834092

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Apr 17, 2013Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Abdominal Aortic Aneurism
Surgery
Ischemic Reperfusion Injury

Interventions

Plasma

Countries

Denmark

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

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jun 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Apr 13, 2013

First Submission Date that Met QC Criteria

Apr 16, 2013

First Posted Date

Apr 17, 2013Estimated

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

Apr 16, 2013

Last Update Posted Date

Apr 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The investigators want to measure the degradation of the endothelial glycocalyx before and after clamping the aorta, in patients operated for a abdominal aortic aneurism.

Detailed Description

50 patients is scheduled for enrollment. Blood samples will be up taken before surgery, 10 min after reperfusion, at the end of surgery and the following morning. In addition the investigators are placing a renal venous catheter where blood samples will be up taken as mentioned above for the analysis of endothelial markers together with markers for kidney damage.

The first 10 patient will act as part of a pilot study, where only measurement of the endothelial and renal failure markers will be performed.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fresh frozen plasma	Active Comparator	2 portions of FFP will be transfused prior to reperfusion	Other: Plasma
Fresh non-frozen plasma	Experimental	2 portions of non-frozen plasma will be transfused prior to reperfusion	Other: Plasma

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasma	Other	2 Units of plasma transfused equvilant to 2 times 275ml	Fresh frozen plasma Fresh non-frozen plasma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endothelial dysfunction	Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Fluid balance	Perioperative and postoperative first 24 hours	24 hours

Other Outcomes

Measure	Description	Time Frame
Postoperative organ failure	Development of kidney- and respiratory failure and sepsis	30 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

above 18 years

Exclusion Criteria:

prior engagement in scientific study within the last 30 days.

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

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas B Jørgensen, MD	Contact	+4535458734		thomas.bech.aaa@gmail.com

Overall Officials

Name	Affiliation	Role
Per I Johansson, MD	Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet	Recruiting	Copenhagen	Østerbro	2000	Denmark