NCT01834092

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 17, 2013

Status Verified

April 1, 2013

Enrollment Period

1.2 years

First QC Date

April 13, 2013

Last Update Submit

April 16, 2013

Conditions

Abdominal Aortic AneurismSurgeryIschemic Reperfusion Injury

Keywords

Abdominal Aortic AneurismEndotheliaGlycocalyxReperfusionPlasma

Outcome Measures

Primary Outcomes (1)

  • Endothelial dysfunction

    Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1

    24 hours

Secondary Outcomes (1)

  • Fluid balance

    24 hours

Other Outcomes (1)

  • Postoperative organ failure

    30 days

Study Arms (2)

Fresh frozen plasma

ACTIVE COMPARATOR

2 portions of FFP will be transfused prior to reperfusion

Other: Plasma

Fresh non-frozen plasma

EXPERIMENTAL

2 portions of non-frozen plasma will be transfused prior to reperfusion

Other: Plasma

Interventions

PlasmaOTHER

2 Units of plasma transfused equvilant to 2 times 275ml

Also known as: Fresh frozen plasma versus fresh non-frozen plasma
Fresh frozen plasmaFresh non-frozen plasma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • above 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Østerbro, 2000, Denmark

RECRUITING

Study Officials

  • Per I Johansson, MD

    Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.

    STUDY CHAIR

Central Study Contacts

Thomas B Jørgensen, MD

CONTACT

+4535458734thomas.bech.aaa@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 13, 2013

First Posted

April 17, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

April 17, 2013

Record last verified: 2013-04

Locations

DK(1)