NCT02189512

Brief Summary

The aim of this study is to study the impact of brain death and surgical small bowel manipulation on the release of different types of monocytes.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

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

May 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 14, 2014

Status Verified

May 1, 2014

Enrollment Period

1.7 years

First QC Date

May 27, 2014

Last Update Submit

July 10, 2014

Conditions

Intestinal Manipulation

Keywords

brain-death organ donorsintestinal manipulationmonocytes

Outcome Measures

Primary Outcomes (2)

  • subtypes of monocytes

    evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection

    1 day

  • evaluate effect of intestinal manipulation

    evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines

    1 day

Study Arms (2)

brain death organ donors

OTHER

cases - blood sampling

Other: blood sampling

abdominal aortic aneurysm repair

OTHER

controls - blood sampling

Other: blood sampling

Interventions

blood samplingOTHER

cases - blood sampling controles - blood sampling

abdominal aortic aneurysm repairbrain death organ donors

Eligibility Criteria

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

You may qualify if:

  • patients who are brain death
  • patients who undergo an elective abdominal aortic aneurysm repair

You may not qualify if:

  • \< 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jacques Pirenne, MD,PhD

    Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurens Ceulemans, MD

CONTACT

+32 16 341545Ceulemans.laurens@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2014

First Posted

July 14, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

July 14, 2014

Record last verified: 2014-05

Locations

BE(1)