Cardiac SurgeryNCT00617955
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
An observational study of Cardiac Surgery, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The dept. of Anesthesiology currently has a database of subjects whom had surgery and received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is more harmful than Amicard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Aprotinin and Amicar
- How many people
- 462 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 2009
- Phase
- Observational
- 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
Study population: Cardiac Surgery patients
Who may be able to join
- Subjects must be 18 years of age or older
- Subjects must have received either Aprotinin or Amicar during cardiac surgery
Who cannot join
- Cardiac surgery and did not receive Aprotinin or Amicar
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates
The dept. of Anesthesiology currently has a database of subjects whom had surgery and received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is more harmful than Amicard. In an effort to see what the long term outcomes were for subjects whom had surgery here at Upstate, it was decided to look at long term death rates to see if any differences. A student t-test will be used to determine statistical significance where a p value of <0.05 will be deemed significant. Using data from 462 subjects that had undergone cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality rate from the Mangano, et.al. publications, the unadjusted mortality for the two drugs are Aprotinin 5.4% and Amicar 1.2%. A power analysis was performed using the hospital mortality rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05. The result was a power of 81.7%.
Read the detailed description
Charts for 462 subjects will be reviewed from 2002-2005 based on the surgery performed. From each chart, the subject name, date of birth,and social security number will be recorded along with the state of residence and year of surgery. This information will be transferred to a CD that is encrypted and password protected. The CD will be sent via FedEx overnight to the Center for Disease Control(CDC), National Death Registry. The CDC will use the information on the CD to extract death outcomes for each subject's information provided. Once all information is complete, the CDC will transfer on to a CD that is encrypted and password protected and return to our office via FexEx overnight. The information on the CD will then be used to determine what the long term death rates were for subjects here at SUNY Upstate Medical University and stored in an anonymous database. Once the information is verified as accurate, the CD will be destroyed and no identifying information will be kept. The CDC will also destroy the information after 60 days, with no links to the identifying information.
- Conditions
- Cardiac Surgery
- Being tested
- Aprotinin, Amicar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AprotininDrug
compare outcomes of Aprotinin versus Amicar
AmicarDrug
compare outcomes of Aprotinin versus Amicar
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Cardiac surgery patients that received Aprotinin or Amicar Receives: Drug: Aprotinin; Drug: Amicar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term death rates
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Nancy A Nussmeier, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617955
- Sponsor's protocol ID
- Aprotinin
- Other IDs
- IRB Exempt #10-06, IRB #5571, NDI Y7-X070
- Status last verified
- Dec 2009
- First submitted
- 6 Feb 2008
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates
- ClinicalTrials.gov ID
- NCT00617955
- Acronym / sponsor ID
- Aprotinin
- Conditions
- Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Feb 2008 (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 dept. of Anesthesiology currently has a database of subjects whom had surgery and received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is more harmful than Amicard. In an effort to see what the long term outcomes were for subjects whom had surgery here at Upstate, it was decided to look at long term death rates to see if any differences. A student t-test will be used to determine statistical significance where a p value of <0.05 will be deemed significant. Using data from 462 subjects that had undergone cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality rate from the Mangano, et.al. publications, the unadjusted mortality for the two drugs are Aprotinin 5.4% and Amicar 1.2%. A power analysis was performed using the hospital mortality rates of 5.4% and 1.2% with the sample size in the propensity data and a p-value of 0.05. The result was a power of 81.7%.
Detailed description
Charts for 462 subjects will be reviewed from 2002-2005 based on the surgery performed. From each chart, the subject name, date of birth,and social security number will be recorded along with the state of residence and year of surgery. This information will be transferred to a CD that is encrypted and password protected. The CD will be sent via FedEx overnight to the Center for Disease Control(CDC), National Death Registry. The CDC will use the information on the CD to extract death outcomes for each subject's information provided. Once all information is complete, the CDC will transfer on to a CD that is encrypted and password protected and return to our office via FexEx overnight. The information on the CD will then be used to determine what the long term death rates were for subjects here at SUNY Upstate Medical University and stored in an anonymous database. Once the information is verified as accurate, the CD will be destroyed and no identifying information will be kept. The CDC will also destroy the information after 60 days, with no links to the identifying information.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | Drug: Aprotinin, Drug: AmicarCardiac surgery patients that received Aprotinin or Amicar |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac Surgery patients
Key inclusion criteria (2 listed)
- Subjects must be 18 years of age or older
- Subjects must have received either Aprotinin or Amicar during cardiac surgery
Key exclusion criteria (1 listed)
- Cardiac surgery and did not receive Aprotinin or Amicar
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 |
|---|---|---|
| Aprotinincompare outcomes of Aprotinin versus Amicar | Drug | Surgical |
| Amicarcompare outcomes of Aprotinin versus Amicar | Drug | Surgical |
Primary outcome
Long term death rates
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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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.
Nancy A Nussmeier, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by State University of New York - Upstate Medical University at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 19 Apr 2016. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term death rates (time frame: 4 years). 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 19 Apr 2016.