Blood Loss, SurgicalPhase 3NCT00306137
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer
A Phase 3 study testing Trasylol (Aprotinin, BAYA0128) in people with Blood Loss, Surgical, run by Bayer at 21 sites in 10 countries.
Trial summary
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical
- 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
- 104 participants
- Where
- 21 sitesin 10 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
- Men or women 18 years of age and older
- Subjects requiring protocol specified oncological surgery. Subjects must have histological confirmation of malignancy in lung or esophagus
- Documented, signed and 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 undergoing laparoscopic surgery
- Subjects with sepsis or mesothelioma
- 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)
Show all 10Show fewer
- Subjects who have participated in an investigational drug study within the past 30 days
- 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
21 sites in 10 countries.
21 sites in 10 countries
United States12 sites
Study site
Atlanta, Georgia, 30322
Study site
Augusta, Georgia, 30912
Study site
Boston, Massachusetts, 02115-6195
Study site
Charlottesville, Virginia, 22908
Study site
Cleveland, Ohio, 44106-2602
Study site
Durham, North Carolina, 27710
Study site
Houston, Texas, 77030
Study site
Indianapolis, Indiana, 46202
Study site
Indianapolis, Indiana, 46260
Study site
Pittsburgh, Pennsylvania, 15213-2592
Study site
Salt Lake City, Utah, 84108
Study site
St Louis, Missouri, 63110-1094
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
- Conditions
- Blood Loss, Surgical
- Being tested
- Trasylol (Aprotinin, BAYA0128), Placebo
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trasylol (Aprotinin, BAYA0128)Drug
Subjects successfully meeting all screening criteria 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 aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride.
Subjects will be stratified into one of the 4 following strata:
- Stratum 1: complete primary pneumonectomy
- Stratum II: decortication or completion pneumonectomy
- Stratum III: esophagectomy by transhiatal approach
- Stratum IV: esophagectomy by transthoracic approach
PlaceboDrug
Placebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride.
| 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.
Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period
Measured: Up to the end of follow up visit (4 to 8 weeks)
Secondary outcomes (10)
Number of units of blood or packed red cells transfused
Measured: Up to the end of follow up visit (4 to 8 weeks)
Number of units transfused per patient
Measured: Up to the end of follow up visit (4 to 8 weeks)
Intra-operative blood loss
Measured: Intra-operative
Drainage volume
Measured: Until removal of drains
Transfusion of platelets, colloids and plasma
Measured: Up to the end of follow up visit (4 to 8 weeks)
Change from pre-operative to post-operative hemoglobin concentration
Measured: At day 3 or earlyer prior to transfusion
Surgeon's assessment of obscurement of operative field by bleeding
Measured: Up to the end of follow up visit (4 to 8 weeks)
Blood markers of inflammation and coagulation
Measured: Up to the end of follow up visit (4 to 8 weeks)
Time to discontinuation of mechanical ventilation
Measured: Until removal of mechanical ventilation
Health related quality of life measurements
Measured: Up to the end of follow up visit (4 to 8 weeks)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
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
- NCT00306137
- Sponsor's protocol ID
- 11800
- Other IDs
- EudraCT: 2005-004689-18
- Status last verified
- Dec 2014
- First submitted
- 21 Mar 2006
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 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, Parallel Design, 2-Arm Study to Investigate the Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung Cancer or Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00306137
- Acronym / sponsor ID
- 11800
- Conditions
- Blood Loss, Surgical
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 104 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.
Study to Investigate the Effect of Aprotinin of Transfusion Requirements in Patients Undergoing Surgical Procedures for Lung or Esophageal Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- 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)
- Men or women 18 years of age and older
- Subjects requiring protocol specified oncological surgery. Subjects must have histological confirmation of malignancy in lung or esophagus
- Documented, signed and dated informed consent obtained prior to any study specific procedures being performed
Key exclusion criteria (10 listed)
- Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin
- Subjects undergoing laparoscopic surgery
- Subjects with sepsis or mesothelioma
- 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.
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 successfully meeting all screening criteria 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 aprotinin was supplied in infusion vials of 200mL solution containing 2,000,000 KIU (10,000 KIU/mL) in 0.9% sodium chloride. Subjects will be stratified into one of the 4 following strata: * Stratum 1: complete primary pneumonectomy * Stratum II: decortication or completion pneumonectomy * Stratum III: esophagectomy by transhiatal approach * Stratum IV: esophagectomy by transthoracic approach | Drug | Arm 1 |
| PlaceboPlacebo solution was supplied in identical vials and will consist of 200mL of 0.9% sodium chloride. | Drug | Arm 2 |
Primary outcome
Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period
Time frame: Up to the end of follow up visit (4 to 8 weeks)
10 secondary outcomes
Number of units of blood or packed red cells transfused
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Number of units transfused per patient
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Intra-operative blood loss
Time frame: Intra-operative
Drainage volume
Time frame: Until removal of drains
Transfusion of platelets, colloids and plasma
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Change from pre-operative to post-operative hemoglobin concentration
Time frame: At day 3 or earlyer prior to transfusion
Surgeon's assessment of obscurement of operative field by bleeding
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Blood markers of inflammation and coagulation
Time frame: Up to the end of follow up visit (4 to 8 weeks)
Time to discontinuation of mechanical ventilation
Time frame: Until removal of mechanical ventilation
Health related quality of life measurements
Time frame: Up to the end of follow up visit (4 to 8 weeks)
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 9 Dec 2014.
- Click here and search for product information provided by EMALink provided by the sponsor.
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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
21 sites in 10 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, run by Bayer at 21 sites in 10 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 10 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 9 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 21 sites in United States, Australia, Austria, Belgium, Canada and 5 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?
Percent of patients requiring a blood transfusion anytime in the intra-operative or post-operative period (time frame: Up to the end of follow up visit (4 to 8 weeks)). 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 9 Dec 2014.