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Study of the Glycocalyx in Abdominal Aortic Aneurysm (Endo_eAAA)

Primary Purpose

Abdominal Aortic Aneurism, Surgery, Ischemic Reperfusion Injury

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Plasma
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Aortic Aneurism focused on measuring Abdominal Aortic Aneurism, Endothelia, Glycocalyx, Reperfusion, Plasma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • above 18 years

Exclusion Criteria:

  • prior engagement in scientific study within the last 30 days.

Sites / Locations

  • RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fresh frozen plasma

Fresh non-frozen plasma

Arm Description

2 portions of FFP will be transfused prior to reperfusion

2 portions of non-frozen plasma will be transfused prior to reperfusion

Outcomes

Primary Outcome Measures

Endothelial dysfunction
Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1

Secondary Outcome Measures

Fluid balance
Perioperative and postoperative first 24 hours

Full Information

First Posted
April 13, 2013
Last Updated
April 16, 2013
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01834092
Brief Title
Study of the Glycocalyx in Abdominal Aortic Aneurysm
Acronym
Endo_eAAA
Official Title
Measurement of the Endothelial Function in Patients With a Abdominal Aortic Aneurism.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurism, Surgery, Ischemic Reperfusion Injury
Keywords
Abdominal Aortic Aneurism, Endothelia, Glycocalyx, Reperfusion, Plasma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fresh frozen plasma
Arm Type
Active Comparator
Arm Description
2 portions of FFP will be transfused prior to reperfusion
Arm Title
Fresh non-frozen plasma
Arm Type
Experimental
Arm Description
2 portions of non-frozen plasma will be transfused prior to reperfusion
Intervention Type
Other
Intervention Name(s)
Plasma
Other Intervention Name(s)
Fresh frozen plasma versus fresh non-frozen plasma
Intervention Description
2 Units of plasma transfused equvilant to 2 times 275ml
Primary Outcome Measure Information:
Title
Endothelial dysfunction
Description
Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Fluid balance
Description
Perioperative and postoperative first 24 hours
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Postoperative organ failure
Description
Development of kidney- and respiratory failure and sepsis
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: above 18 years Exclusion Criteria: prior engagement in scientific study within the last 30 days.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas B Jørgensen, MD
Phone
+4535458734
Email
thomas.bech.aaa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per I Johansson, MD
Organizational Affiliation
Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Østerbro
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas B Jørgensen, MD
Phone
+4535458734
Email
thomas.bech.aaa@gmail.com
First Name & Middle Initial & Last Name & Degree
Thomas B Jørgensen, MD

12. IPD Sharing Statement

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Study of the Glycocalyx in Abdominal Aortic Aneurysm

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