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Study of the Glycocalyx in Abdominal Aortic Aneurysm (Endo_eAAA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Thomas Bech Jorgensen, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Thomas Bech Jorgensen, Rigshospitalet, Denmark Identifier:
First received: April 13, 2013
Last updated: April 16, 2013
Last verified: April 2013
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.

Condition Intervention
Abdominal Aortic Aneurism
Ischemic Reperfusion Injury
Other: Plasma

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Measurement of the Endothelial Function in Patients With a Abdominal Aortic Aneurism.

Resource links provided by NLM:

Further study details as provided by Thomas Bech Jorgensen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Endothelial dysfunction [ Time Frame: 24 hours ]
    Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1

Secondary Outcome Measures:
  • Fluid balance [ Time Frame: 24 hours ]
    Perioperative and postoperative first 24 hours

Other Outcome Measures:
  • Postoperative organ failure [ Time Frame: 30 days ]
    Development of kidney- and respiratory failure and sepsis

Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Fresh frozen plasma versus fresh non-frozen plasma

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • above 18 years

Exclusion Criteria:

  • prior engagement in scientific study within the last 30 days.
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Please refer to this study by its identifier: NCT01834092

Contact: Thomas B Jørgensen, MD +4535458734

Rigshospitalet Recruiting
Copenhagen, Østerbro, Denmark, 2000
Contact: Thomas B Jørgensen, MD    +4535458734   
Principal Investigator: Thomas B Jørgensen, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Study Chair: Per I Johansson, MD Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.
  More Information

Responsible Party: Thomas Bech Jorgensen, MD, Rigshospitalet, Denmark Identifier: NCT01834092     History of Changes
Other Study ID Numbers: H-4-2012-085
Study First Received: April 13, 2013
Last Updated: April 16, 2013

Keywords provided by Thomas Bech Jorgensen, Rigshospitalet, Denmark:
Abdominal Aortic Aneurism

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Postoperative Complications
Pathologic Processes processed this record on May 25, 2017