Study of the Glycocalyx in Abdominal Aortic Aneurysm

Not Applicable

• Conditions: Abdominal Aortic Aneurism; Surgery; Ischemic Reperfusion Injury
• Interventions: Other: Plasma

• Registration Number: NCT01834092
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-13
• Study First Submitted QC: 2013-04-16
• Last Update Submitted: 2013-04-16
• Study First Posted: 2013-04-17
• Last Update Posted: 2013-04-17
• Primary Completion: 2014-06
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• above 18 years

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fresh frozen plasma	Plasma	2 portions of FFP will be transfused prior to reperfusion
Fresh non-frozen plasma	Plasma	2 portions of non-frozen plasma will be transfused prior to reperfusion

Primary Outcome Measures

Name	Time	Method
Endothelial dysfunction	24 hours	Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1

Secondary Outcome Measures

Name	Time	Method
Fluid balance	24 hours	Perioperative and postoperative first 24 hours

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Østerbro, Denmark