Study of the Glycocalyx in Abdominal Aortic Aneurysm (Endo_eAAA)

This study is currently recruiting participants.
Verified April 2013 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Thomas Bech Jorgensen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01834092
First received: April 13, 2013
Last updated: April 16, 2013
Last verified: April 2013

April 13, 2013
April 16, 2013
April 2013
June 2014   (final data collection date for primary outcome measure)
Endothelial dysfunction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1
Same as current
Complete list of historical versions of study NCT01834092 on ClinicalTrials.gov Archive Site
Fluid balance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Perioperative and postoperative first 24 hours
Same as current
Postoperative organ failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Development of kidney- and respiratory failure and sepsis
Same as current
 
Study of the Glycocalyx in Abdominal Aortic Aneurysm
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Abdominal Aortic Aneurism
  • Surgery
  • Ischemic Reperfusion Injury
Other: Plasma
2 Units of plasma transfused equvilant to 2 times 275ml
Other Name: Fresh frozen plasma versus fresh non-frozen plasma
  • Active Comparator: Fresh frozen plasma
    2 portions of FFP will be transfused prior to reperfusion
    Intervention: Other: Plasma
  • Experimental: Fresh non-frozen plasma
    2 portions of non-frozen plasma will be transfused prior to reperfusion
    Intervention: Other: Plasma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
July 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • above 18 years

Exclusion Criteria:

  • prior engagement in scientific study within the last 30 days.
Both
18 Years and older
No
Contact: Thomas B Jørgensen, MD +4535458734 thomas.bech.aaa@gmail.com
Denmark
 
NCT01834092
H-4-2012-085
No
Thomas Bech Jorgensen, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Study Chair: Per I Johansson, MD Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.
Rigshospitalet, Denmark
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP