Study of the Glycocalyx in Abdominal Aortic Aneurysm (Endo_eAAA)

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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
Surgery
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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Endothelial dysfunction [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1


Secondary Outcome Measures:
  • Fluid balance [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Perioperative and postoperative first 24 hours


Other Outcome Measures:
  • Postoperative organ failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • above 18 years

Exclusion Criteria:

  • prior engagement in scientific study within the last 30 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834092

Contacts
Contact: Thomas B Jørgensen, MD +4535458734 thomas.bech.aaa@gmail.com

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

No publications provided

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

Keywords provided by Rigshospitalet, Denmark:
Abdominal Aortic Aneurism
Endothelia
Glycocalyx
Reperfusion
Plasma

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aneurysm
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014