Ischemia-ReperfusionPhase 3NCT00821158
The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
A Phase 3 study testing Antioxidant and Anti-inflammatory drug in people with Ischemia-Reperfusion, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ischemia-Reperfusion
- What is being tested?
- Antioxidant and Anti-inflammatory drug
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2009to Feb 2011
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing breast reconstruction
Who cannot join
- Diabetes mellitus
- Kidney or liver disease
- Use of immunosuppressants
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, P.O. Box 5800, 6202 AZ
Marieke van den Heuvel, M.D., 0031-43-3875496, m.vandenheuvel@ah.unimaas.nl
Marieke van den Heuvel, M.D.
About this study
The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.
- Conditions
- Ischemia-Reperfusion
- Being tested
- Antioxidant, Placebo, Anti-inflammatory drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntioxidantDrug
Antioxidant iv bolus
PlaceboOther
Placebo tablet and iv
Anti-inflammatory drugDrug
Anti-inflammatory tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo tablet and iv Receives: Other: Placebo |
| 2 | Experimental | Placebo tablet and intervention iv Receives: Drug: Antioxidant |
| 3 | Experimental | Intervention tablet and placebo iv Receives: Drug: Anti-inflammatory drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant concentrations
Measured: 0,5-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-ReperfusionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- R. van der Hulst, M.D., Phd, Study chair, Maastricht Universtity Medical CenterMarieke van den Heuvel, M.D., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821158
- Sponsor's protocol ID
- MEC 25-11-2008
- Status last verified
- Jan 2009
- First submitted
- 12 Jan 2009
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
- ClinicalTrials.gov ID
- NCT00821158
- Acronym / sponsor ID
- MEC 25-11-2008
- Conditions
- Ischemia-Reperfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (estimated)
- First posted
- 13 Jan 2009 (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 will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: PlaceboPlacebo tablet and iv |
| 2 | Experimental | Drug: AntioxidantPlacebo tablet and intervention iv |
| 3 | Experimental | Drug: Anti-inflammatory drugIntervention tablet and placebo iv |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing breast reconstruction
Key exclusion criteria (3 listed)
- Diabetes mellitus
- Kidney or liver disease
- Use of immunosuppressants
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 |
|---|---|---|
| AntioxidantAntioxidant iv bolus | Drug | 2 |
| PlaceboPlacebo tablet and iv | Other | 1 |
| Anti-inflammatory drugAnti-inflammatory tablet | Drug | 3 |
Primary outcome
Antioxidant concentrations
Time frame: 0,5-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
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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.
R. van der Hulst, M.D., Phd study chair
Maastricht Universtity Medical Center
Marieke van den Heuvel, M.D. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antioxidant and Anti-inflammatory drug in people with Ischemia-Reperfusion, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 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 13 Jan 2009. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Marieke van den Heuvel, M.D. (0031-43-3875496, m.vandenheuvel@ah.unimaas.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant concentrations (time frame: 0,5-24 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 13 Jan 2009.