Blood Loss, SurgicalPhase 3NCT00327379
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
A Phase 3 study testing Trasylol (Aprotinin, BAYA0128) in people with Blood Loss, Surgical and Postoperative Hemorrhage, run by Bayer at 14 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation 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
- 54 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 27 Feb 2006to 1 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 requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces.
Who cannot join
- Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.- Subjects with a known or suspected allergy to aprotinin.
- Subjects with sepsis or a known bone infection.- Subjects with known bone malignancy.
- Subjects with a creatinine clearance less than 30mL/min as calculated by the Cockcroft-Gault formula.
- Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
- Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Subjects who refuse to receive allogenic blood products for religious or other reasons.
Show all 14Show fewer
- Subjects whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit or hemoglobin values <24% or <8 g/dl, respectively).
- Subjects who have participated in an investigational drug study within the past 30 days
- Subjects with a history of deep vein thrombosis or pulmonary embolism.
- Subjects who are pregnant or breast feeding.
- Women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative serum pregnancy test at screening.
- Women of childbearing potential who are not using a reliable method of contraception.
- Planned use of other antifibrinolytic agents.
- Subjects on chronic anticoagulant treatment with Vit K antagonists that cannot be temporarily discontinued for the surgical procedure (as per local practices).
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
Spain6 sites
Study site
Barcelona, 08003
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Madrid, 28034
Study site
Pamplona, 31008
Study site
Valencia, 46010
Germany5 sites
Study site
Berlin, 13086
Study site
Berlin, 13353
Study site
Karlsbad, Baden-Wurttemberg, 76307
Study site
Münster, North Rhine-Westphalia, 48149
Study site
Neustadt, Schleswig-Holstein, 23730
Canada3 sites
Study site
Montreal, Quebec, H3A 2B4
Study site
Oshawa, Ontario, L1G 2B9
Study site
Windsor, Ontario, N9A 1E1
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 Elective Spinal Fusion Surgery
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation
- Conditions
- Blood Loss, Surgical, Postoperative Hemorrhage
- Being tested
- Trasylol (Aprotinin, BAYA0128), Placebo
- Keywords
- Bloodloss, Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
- 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
Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
PlaceboDrug
Infusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery)
| 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 (blood or packed red blood cells, autologous or allogenic)
Measured: anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge).
Secondary outcomes (11)
The percent of patients receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge
Measured: surgery to discharge
The percent of patients who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge
Measured: surgery to discharge
The number of units of blood or packed red cells transfused. There will be analyses for the combination of autologous and allogenic transfusion and for allogenic alone
Measured: surgery to discharge
The number of units of blood or packed red cells transfused per patient requiring transfusion
Measured: surgery to discharge
Drainage (in milliliters) from the operative site in the first 8 hours postoperatively, and total drainage until removal of drains or until hospital discharge (whichever is earlier)
Measured: surgery to discharge
Blood loss during surgery, based on qualitative and quantitative estimates
Measured: surgery
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).
Measured: pre-op and day 3 post surgery
Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures
Measured: surgery to discharge
The percent of patients receiving colloid or other blood products, and the number of units transfused
Measured: surgery to discharge
Changes in blood markers related to inflammation and blood coagulation
Measured: surgery to discharge
Changes in FEV1
Measured: surgery to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2006 (estimated)
- Study start27 Feb 2006
- Primary completion1 Mar 2007
- Study completion1 Mar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 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
- NCT00327379
- Sponsor's protocol ID
- 11799
- Other IDs
- 2005-003999-38, 2005
- Status last verified
- Jun 2019
- First submitted
- 16 May 2006
- Last updated
- 4 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. 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 Elective Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT00327379
- Acronym / sponsor ID
- 11799
- Conditions
- Blood Loss, Surgical, Postoperative Hemorrhage
- Keywords
- Bloodloss, Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2006 (actual)
- Primary completion
- 1 Mar 2007 (actual)
- Study completion
- 1 Mar 2007 (actual)
- First posted
- 18 May 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 objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation
Study design
- Primary purpose
- Prevention
- 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 (1 listed)
- Subjects requiring elective spinal fusion surgery involving 3 to 7 vertebral levels with instrumentation. One vertebral level is defined as encompassing two vertebral bodies and one inter-vertebral disc space, so that a contiguous spinal fusion involving 3 vertebral levels would include 4 vertebral bodies and 3 inter-vertebral disc spaces.
Key exclusion criteria (14 listed)
- Subjects with previous exposure to aprotinin in the last 6 months. If the subject has undergone cardiac surgery in the last 6 months, all attempts should be made to ascertain if aprotinin was administered during cardiac surgery. If no records are available, or if the subject received aprotinin, the subject should be excluded.- Subjects with a known or suspected allergy to aprotinin.
- Subjects with sepsis or a known bone infection.- Subjects with known bone malignancy.
- Subjects with a creatinine clearance less than 30mL/min as calculated by the Cockcroft-Gault formula.
- Subjects with a history of bleeding diathesis or known coagulation factor deficiency.
- Subjects with failure of a major organ system or any active significant medical illness that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
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)Infusion of aprotinin (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery) | Drug | Arm 1 |
| PlaceboInfusion of placebo (loading dose of 2 million KIU (Kallikrein Inhibitor Units) followed by 500,000 KIU/hour until the end of surgery) | Drug | Arm 2 |
Primary outcome
Percent of patients requiring a blood transfusion (blood or packed red blood cells, autologous or allogenic)
Time frame: anytime in the intra-operative or postoperative period (up to the earlier of Day 7 or discharge).
11 secondary outcomes
The percent of patients receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge
Time frame: surgery to discharge
The percent of patients who did and did not predonate blood receiving an allogenic transfusion of blood or packed red cells during surgery and up to the earlier of Day 7 or discharge
Time frame: surgery to discharge
The number of units of blood or packed red cells transfused. There will be analyses for the combination of autologous and allogenic transfusion and for allogenic alone
Time frame: surgery to discharge
The number of units of blood or packed red cells transfused per patient requiring transfusion
Time frame: surgery to discharge
Drainage (in milliliters) from the operative site in the first 8 hours postoperatively, and total drainage until removal of drains or until hospital discharge (whichever is earlier)
Time frame: surgery to discharge
Blood loss during surgery, based on qualitative and quantitative estimates
Time frame: surgery
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of Day 3, or, if transfused earlier, prior to transfusion).
Time frame: pre-op and day 3 post surgery
Surgeons assessment of the degree to which bleeding obscured his/her view of the surgical field, relative to past, similar procedures
Time frame: surgery to discharge
The percent of patients receiving colloid or other blood products, and the number of units transfused
Time frame: surgery to discharge
Changes in blood markers related to inflammation and blood coagulation
Time frame: surgery to discharge
Changes in FEV1
Time frame: surgery to discharge
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 4 Jun 2019.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink 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
14 sites in 3 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 14 sites in 3 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 1 inclusion and 14 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 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, Germany, Canada. 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 (blood or packed red blood cells, autologous or allogenic) (time frame: anytime in the intra-operative or postoperative 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 4 Jun 2019.