Abdominal Aortic AneurismEndo_eAAANCT01834092
Study of the Glycocalyx in Abdominal Aortic Aneurysm
A study testing Plasma in people with Abdominal Aortic Aneurism and Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurism, Surgery, Ischemic Reperfusion Injury
- What is being tested?
- Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- above 18 years
Who cannot join
- prior engagement in scientific study within the last 30 days.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, Østerbro, 2000
Thomas B Jørgensen, MD, +4535458734, thomas.bech.aaa@gmail.com
Thomas B Jørgensen, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Plasma
- Keywords
- Abdominal Aortic Aneurism, Endothelia, Glycocalyx, Reperfusion, Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlasmaOther
Also called Fresh frozen plasma versus fresh non-frozen plasma
2 Units of plasma transfused equvilant to 2 times 275ml
| Study group | Role | What they receive |
|---|---|---|
| Fresh frozen plasma | Active comparator | 2 portions of FFP will be transfused prior to reperfusion Receives: Other: Plasma |
| Fresh non-frozen plasma | Experimental | 2 portions of non-frozen plasma will be transfused prior to reperfusion Receives: Other: Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial dysfunction
Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1
Measured: 24 hours
Secondary outcomes (1)
Fluid balance
Perioperative and postoperative first 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurismStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Bech Jorgensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Per I Johansson, MD, Study chair, Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834092
- Sponsor's protocol ID
- H-4-2012-085
- Acronym
- Endo_eAAA
- Status last verified
- Apr 2013
- First submitted
- 13 Apr 2013
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of the Endothelial Function in Patients With a Abdominal Aortic Aneurism.
- ClinicalTrials.gov ID
- NCT01834092
- Acronym / sponsor ID
- Endo_eAAA / H-4-2012-085
- Keywords
- Abdominal Aortic Aneurism, Endothelia, Glycocalyx, Reperfusion, Plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh frozen plasma | Active comparator | Other: Plasma2 portions of FFP will be transfused prior to reperfusion |
| Fresh non-frozen plasma | Experimental | Other: Plasma2 portions of non-frozen plasma will be transfused prior to reperfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- above 18 years
Key exclusion criteria (1 listed)
- prior engagement in scientific study within the last 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlasmaAlso: Fresh frozen plasma versus fresh non-frozen plasma2 Units of plasma transfused equvilant to 2 times 275ml | Other | Fresh frozen plasma, Fresh non-frozen plasma |
Primary outcome
Endothelial dysfunction
Time frame: 24 hours
Measurement of endothelial markers peri- and postoperative: thrombomodulin, E-selectin and syndecan-1
1 secondary outcome
Fluid balance
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per I Johansson, MD study chair
Section for Transfusion Medicine, Capital Region Blood Bank, Rigshospitalet, Copenhagen, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma in people with Abdominal Aortic Aneurism and Surgery, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas B Jørgensen, MD (+4535458734, thomas.bech.aaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial dysfunction (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2013.