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The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

Primary Purpose

Ischemia-Reperfusion

Status
Unknown status
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Antioxidant
Placebo
Anti-inflammatory drug
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemia-Reperfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing breast reconstruction

Exclusion Criteria:

  • Diabetes mellitus
  • Kidney or liver disease
  • Use of immunosuppressants

Sites / Locations

  • Maastricht University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Placebo tablet and iv

Placebo tablet and intervention iv

Intervention tablet and placebo iv

Outcomes

Primary Outcome Measures

Antioxidant concentrations

Secondary Outcome Measures

Full Information

First Posted
January 12, 2009
Last Updated
January 12, 2009
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00821158
Brief Title
The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
Official Title
The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia-Reperfusion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo tablet and iv
Arm Title
2
Arm Type
Experimental
Arm Description
Placebo tablet and intervention iv
Arm Title
3
Arm Type
Experimental
Arm Description
Intervention tablet and placebo iv
Intervention Type
Drug
Intervention Name(s)
Antioxidant
Intervention Description
Antioxidant iv bolus
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet and iv
Intervention Type
Drug
Intervention Name(s)
Anti-inflammatory drug
Intervention Description
Anti-inflammatory tablet
Primary Outcome Measure Information:
Title
Antioxidant concentrations
Time Frame
0,5-24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing breast reconstruction Exclusion Criteria: Diabetes mellitus Kidney or liver disease Use of immunosuppressants
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marieke van den Heuvel, M.D.
Phone
0031-43-3875496
Email
m.vandenheuvel@ah.unimaas.nl
First Name & Middle Initial & Last Name or Official Title & Degree
R. van der Hulst, M.D., Phd
Phone
0031-43-3877481
Email
r.vander.hulst@mumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. van der Hulst, M.D., Phd
Organizational Affiliation
Maastricht Universtity Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marieke van den Heuvel, M.D.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
P.O. Box 5800, 6202 AZ
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marieke van den Heuvel, M.D.
Phone
0031-43-3875496
Email
m.vandenheuvel@ah.unimaas.nl
First Name & Middle Initial & Last Name & Degree
Marieke van den Heuvel, M.D.

12. IPD Sharing Statement

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The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study

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