Postoperative HemorrhageNCT00611845
Aprotinin US Special Access Protocol
A study testing Aprotinin (Trasylol, BAYA0128) in people with Postoperative Hemorrhage, run by Bayer at 17 sites in United States.
Trial summary
This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) who are at increased risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Hemorrhage
- What is being tested?
- Aprotinin (Trasylol, BAYA0128)
- How many people
- Not given
- Where
- 17 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
Who may be able to join
- Patients 18 years of age and older
- Patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. These patients may include the following:
- Patients receiving preoperative antithrombotic drugs (e.g., clopidogrel, aspirin),
- Patients undergoing repeat CABG or complex CABG procedures,
- Patients undergoing urgent or emergent CABG procedures,
- Patients who refuse to receive allogeneic blood products for religious or other reasons,
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- Patients undergoing primary CABG with advanced age or multiple comorbidities such as preoperative anemia, coagulopathies, diabetes mellitus, and peripheral vascular disease
- The physician has determined that no acceptable alternative comparable therapy is available for the patient and that there is a clearly favorable benefit-risk for the drug in that individual patient
- Documented, signed, dated informed consent obtained prior to entry into the study
Who cannot join
- Patients with a known or suspected previous aprotinin exposure during the last 12 months. Aprotinin may also be a component of some fibrin sealant products, and the use of these products should be considered when evaluating previous aprotinin exposure
- Patients with a known or suspected allergy to aprotinin.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Asheville, North Carolina, 28805
Study site
Decatur, Alabama, 35601
Study site
Edgewood, Kentucky, 41017
Study site
Fort Wayne, Indiana, 46804
Study site
Glendale, California, 91206
Study site
Knoxville, Tennessee, 37917
Study site
Lynchburg, Virginia, 24501
Study site
Medford, Oregon, 97504
Study site
Milwaukee, Wisconsin, 53215
Study site
New Brunswick, New Jersey, 08903
Study site
Philadelphia, Pennsylvania, 19107
Study site
Pismo Beach, California, 93449
Study site
Portland, Oregon, 97210
Study site
Portland, Oregon, 97225
Study site
Santa Monica, California, 90404
Study site
Ventura, California, 93003
Study site
Wausau, Wisconsin, 54401
About this study
Official title: Aprotinin US Special Access Protocol: An Open Label, Non-Comparative Treatment Protocol for the Use of Aprotinin in Patients Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass Who Are at Increased Risk of Blood Loss and Transfusion
This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of the treating physician, the patients require it, there is no acceptable alternative therapy, and when there is a clearly favorable benefit-risk for the drug in that individual patient.
- Conditions
- Postoperative Hemorrhage
- Being tested
- Aprotinin (Trasylol, BAYA0128)
- Keywords
- CABG surgery requiring CPB and at increased risk of bleeding and blood transfusion
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aprotinin (Trasylol, BAYA0128)Drug
Trasylol at either 1,000,000 KIU or 2,000,000 KIU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative HemorrhageStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611845
- Sponsor's protocol ID
- 13087
- Status last verified
- Jun 2014
- First submitted
- 29 Jan 2008
- Last updated
- 23 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprotinin US Special Access Protocol: An Open Label, Non-Comparative Treatment Protocol for the Use of Aprotinin in Patients Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass Who Are at Increased Risk of Blood Loss and Transfusion
- ClinicalTrials.gov ID
- NCT00611845
- Acronym / sponsor ID
- 13087
- Conditions
- Postoperative Hemorrhage
- Keywords
- CABG surgery requiring CPB and at increased risk of bleeding and blood transfusion
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- First posted
- 11 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.
This is a special access protocol that will allow physicians access to aprotinin during the temporary marketing suspension. The program will provide aprotinin for treatment of surgical patients undergoing coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) who are at increased risk of bleeding and transfusion when, in the opinion of the treating physician, the patients require it, there is no acceptable alternative therapy, and when there is a clearly favorable benefit-risk for the drug in that individual patient.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients 18 years of age and older
- Patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion. These patients may include the following:
- The physician has determined that no acceptable alternative comparable therapy is available for the patient and that there is a clearly favorable benefit-risk for the drug in that individual patient
- Documented, signed, dated informed consent obtained prior to entry into the study
Key exclusion criteria (2 listed)
- Patients with a known or suspected previous aprotinin exposure during the last 12 months. Aprotinin may also be a component of some fibrin sealant products, and the use of these products should be considered when evaluating previous aprotinin exposure
- Patients with a known or suspected allergy to aprotinin.
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 |
|---|---|---|
| Aprotinin (Trasylol, BAYA0128)Trasylol at either 1,000,000 KIU or 2,000,000 KIU | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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.
Bayer Study Director study director
Bayer
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aprotinin (Trasylol, BAYA0128) in people with Postoperative Hemorrhage, run by Bayer at 17 sites 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 9 inclusion and 2 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 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
Results are not available in the source record.
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.
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 23 Jun 2014.