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

NCT ID: NCT00821158

Last Updated: 2009-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Brief Summary

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

Detailed Description

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Conditions

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Ischemia-Reperfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Placebo tablet and iv

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablet and iv

2

Placebo tablet and intervention iv

Group Type EXPERIMENTAL

Antioxidant

Intervention Type DRUG

Antioxidant iv bolus

3

Intervention tablet and placebo iv

Group Type EXPERIMENTAL

Anti-inflammatory drug

Intervention Type DRUG

Anti-inflammatory tablet

Interventions

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Antioxidant

Antioxidant iv bolus

Intervention Type DRUG

Placebo

Placebo tablet and iv

Intervention Type OTHER

Anti-inflammatory drug

Anti-inflammatory tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing breast reconstruction

Exclusion Criteria

* Diabetes mellitus
* Kidney or liver disease
* Use of immunosuppressants
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Maastricht University Medical Center

Principal Investigators

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R. van der Hulst, M.D., Phd

Role: STUDY_CHAIR

Maastricht Universtity Medical Center

Marieke van den Heuvel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Medical Center

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Marieke van den Heuvel, M.D.

Role: CONTACT

0031-43-3875496

R. van der Hulst, M.D., Phd

Role: CONTACT

0031-43-3877481

Facility Contacts

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Marieke van den Heuvel, M.D.

Role: primary

0031-43-3875496

Other Identifiers

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MEC 25-11-2008

Identifier Type: -

Identifier Source: org_study_id

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