Study of the Glycocalyx in Abdominal Aortic Aneurysm (Endo_eAAA)

April 16, 2013 updated by: Thomas Bech Jorgensen, Rigshospitalet, Denmark

Measurement of the Endothelial Function in Patients With a Abdominal Aortic Aneurism.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Østerbro
      • Copenhagen, Østerbro, Denmark, 2000
        • Recruiting
        • Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Thomas B Jørgensen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • above 18 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fresh frozen plasma
2 portions of FFP will be transfused prior to reperfusion
Other: Plasma
2 Units of plasma transfused equvilant to 2 times 275ml
Other Names:
  • Fresh frozen plasma versus fresh non-frozen plasma
Experimental: Fresh non-frozen plasma
2 portions of non-frozen plasma will be transfused prior to reperfusion
Other: Plasma
2 Units of plasma transfused equvilant to 2 times 275ml
Other Names:
  • Fresh frozen plasma versus fresh non-frozen plasma

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Per I Johansson, MD, Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

April 13, 2013

First Submitted That Met QC Criteria

April 16, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

April 17, 2013

Last Update Submitted That Met QC Criteria

April 16, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2012-085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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