Blood Loss, SurgicalPhase 3NCT00306150
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy
A Phase 3 study testing Trasylol (Aprotinin, BAYA0128) in people with Blood Loss, Surgical and Postoperative Hemorrhage, run by Bayer at 37 sites in 7 countries.
Trial summary
The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical, Postoperative Hemorrhage
- What is being tested?
- Trasylol (Aprotinin, BAYA0128)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 37 sitesin 7 countries
- Study dates
- Dec 2005to Mar 2007
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 years of age and older
- Subjects requiring elective radical or total cystectomy for bladder cancer
- Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Who cannot join
- Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin
- Subjects with sepsis or undergoing laparoscopic surgery
- Subjects with impaired renal function (serum creatinine >2.5 mg/dL or 221 micromoles/liter)
- Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have
- Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of <24% or hemoglobin of <8 g/dl)
- Subjects who have participated in an investigational drug study within the past 30 days
Show all 9Show fewer
- Subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception
- Planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid
- Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)
Trial locations and contacts
37 sites in 7 countries.
37 sites in 7 countries
United States18 sites
Study site
Ann Arbor, Michigan, 48109-0330
Study site
Baltimore, Maryland, 21224
Study site
Burlington, Vermont, 05401-1420
Study site
Chapel Hill, North Carolina, 27599-7065
Study site
Chicago, Illinois, 60612
Study site
Chicago, Illinois, 60637
Study site
Cleveland, Ohio, 44106-2602
Study site
Columbus, Ohio, 43214-1419
Study site
Denver, Colorado, 80262
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90095
Study site
Miami, Florida, 33125
Study site
Nashville, Tennessee, 37232
Study site
Oklahoma City, Oklahoma, 73104
Study site
Philadelphia, Pennsylvania, 19107
Study site
Pittsburgh, Pennsylvania, 15213-2592
Study site
Portland, Maine, 04102
Study site
Rochester, Minnesota, 55905
Germany7 sites
Study site
Dresden, Saxony, 01307
Study site
Fulda, Hesse, 36043
Study site
Homburg, Saarland, 66421
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
München, Bavaria, 81377
Study site
Regensburg, Bavaria, 93053
Study site
Tübingen, Baden-Wurttemberg, 72076
Sweden4 sites
Study site
Linköping, 581 85
Study site
Lund, 221 85
Study site
Stockholm, 171 76
Study site
Uppsala, 751 85
Netherlands2 sites
Study site
Maastricht, 6229 HX
Study site
Nijmegen, 6525 GA
United Kingdom2 sites
Study site
Cambridge, Cambridgeshire, CB2 0QQ
Study site
Newcastle upon Tyne, Tyne and Wear, NE7 7DN
About this study
Official title: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.
The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.
- Conditions
- Blood Loss, Surgical, Postoperative Hemorrhage
- Being tested
- Trasylol (Aprotinin, BAYA0128), Placebo
- Keywords
- Prevention of blood loss, Blood Loss, Surgical, Blood Loss, Postoperative
- Medical subject headings
- Blood Loss, Surgical, Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trasylol (Aprotinin, BAYA0128)Drug
Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued.
PlaceboDrug
Placebo is used according to the description of Arm 1
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Trasylol (Aprotinin, BAYA0128) |
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Measured: Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Secondary outcomes (11)
The number of units of blood or packed red cells transfused. There will be an analysis for the combination of autologous and allogenic transfusion and for allogenic alone
Measured: Intra- and postoperative
The number of units of blood or packed red cells transfused per patient requiring transfusion
Measured: Intra- and postoperative
The intraoperative blood loss determined as follow: a) by surgeon estimate b) summing weight of the blood in gauze and other materials and the suction drainage volume
Measured: Intraoperative
The drainage volume (in milliliters) from the operative site
Measured: In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes first
Transfusion of platelets, colloids, plasma and number of patients requiring these products
Measured: Intra- and postoperative
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration
Measured: Obtained in the morning of postoperative Day 3, or, if transfused earlier, prior to transfusion
Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures
Measured: Intraoperative
Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7
Measured: Several measurements from baseline up to 6 weeks
Time to discontinuing of mechanical ventilation
Measured: Not specifed
Changes in FEV1
Measured: Baseline until Discharge or day7
Changes in the patients health related quality of life (HRQoL) (at baseline and 6+-2 weeks post surgery) using the Functional Assessment Cancer Therapy for patients with Bladder cancer (FACT-Bl) questionnaire
Measured: At baseline and 6+-2 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startDec 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306150
- Sponsor's protocol ID
- 12002
- Other IDs
- 2005-004055-35, 2005
- Status last verified
- Dec 2014
- First submitted
- 21 Mar 2006
- Last updated
- 17 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.
- ClinicalTrials.gov ID
- NCT00306150
- Acronym / sponsor ID
- 12002
- Conditions
- Blood Loss, Surgical, Postoperative Hemorrhage
- Keywords
- Prevention of blood loss, Blood Loss, Surgical, Blood Loss, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 57 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 23 Mar 2006 (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 purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Trasylol (Aprotinin, BAYA0128) |
| Arm 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects 18 years of age and older
- Subjects requiring elective radical or total cystectomy for bladder cancer
- Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Key exclusion criteria (9 listed)
- Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin
- Subjects with sepsis or undergoing laparoscopic surgery
- Subjects with impaired renal function (serum creatinine >2.5 mg/dL or 221 micromoles/liter)
- Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have
- Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of <24% or hemoglobin of <8 g/dl)
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 |
|---|---|---|
| Trasylol (Aprotinin, BAYA0128)Subjects will be randomized to receive an infusion of aprotinin (a test dose followed by a loading dose of 2 million KIU before skin incision followed by 500,000 KIU/hour until the end of surgery) or matching placebo. The maximal dose of aprotinin, that can be administered is 7,000,000 KIU, regardless of the duration of the operation. When a total of 7 million has been reached the administration of aprotinin must be discontinued. | Drug | Arm 1 |
| PlaceboPlacebo is used according to the description of Arm 1 | Drug | Arm 2 |
Primary outcome
The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Time frame: Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
11 secondary outcomes
The number of units of blood or packed red cells transfused. There will be an analysis for the combination of autologous and allogenic transfusion and for allogenic alone
Time frame: Intra- and postoperative
The number of units of blood or packed red cells transfused per patient requiring transfusion
Time frame: Intra- and postoperative
The intraoperative blood loss determined as follow: a) by surgeon estimate b) summing weight of the blood in gauze and other materials and the suction drainage volume
Time frame: Intraoperative
The drainage volume (in milliliters) from the operative site
Time frame: In the first 8 hours post-operatively, and daily total drainage until removal of drains or until discharge, whichever comes first
Transfusion of platelets, colloids, plasma and number of patients requiring these products
Time frame: Intra- and postoperative
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration
Time frame: Obtained in the morning of postoperative Day 3, or, if transfused earlier, prior to transfusion
Surgeon s assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures
Time frame: Intraoperative
Changes in blood markers related to inflammation and blood coagulation; baseline until Discharge or day 7
Time frame: Several measurements from baseline up to 6 weeks
Time to discontinuing of mechanical ventilation
Time frame: Not specifed
Changes in FEV1
Time frame: Baseline until Discharge or day7
Changes in the patients health related quality of life (HRQoL) (at baseline and 6+-2 weeks post surgery) using the Functional Assessment Cancer Therapy for patients with Bladder cancer (FACT-Bl) questionnaire
Time frame: At baseline and 6+-2 weeks post surgery
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Click here and search for information of Bayer products for EuropeLink provided by the sponsor.
Related trials for Blood Loss, Surgical
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
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
37 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trasylol (Aprotinin, BAYA0128) in people with Blood Loss, Surgical and Postoperative Hemorrhage, run by Bayer at 37 sites in 7 countries.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Germany, Sweden, Belgium, France and 2 more countries. 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?
The study was stopped early. 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.
What does the primary outcome measure?
The primary criterion for efficacy is the percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge) (time frame: Anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)). 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 17 Dec 2014.