Blood Loss, SurgicalPhase 3NCT00668031
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement
A Phase 3 study testing Trasylol (Aprotinin, BAYA0128) in people with Blood Loss, Surgical, run by Bayer at 40 sites in 3 countries.
Trial summary
The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. 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
- 359 participants
- Where
- 40 sitesin 3 countries
- Study dates
- Feb 2005to Jan 2006
- 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 primary total hip replacement surgery
- 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. 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, subject should be excluded. If during cardiac surgery in the last 6 months, there is a record of aprotinin administration, subject should be excluded
- Subjects with a known or suspected allergy to aprotinin - Subjects with impaired renal function (serum creatinine > 3.5 mg/dl or 309 micromoles/liter)
- 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
Trial locations and contacts
40 sites in 3 countries.
40 sites in 3 countries
United States27 sites
Study site
Aurora, Colorado, 80012
Study site
Baltimore, Maryland, 21215
Study site
Bay Pines, Florida, 33744
Study site
Bend, Oregon, 97701
Study site
Birmingham, Alabama, 35205
Study site
Boise, Idaho, 83702
Study site
Dallas, Texas, 75231
Study site
Durham, North Carolina, 27710
Study site
Farmington, Connecticut, 06032
Study site
Greensboro, North Carolina, 27401
Study site
Indianapolis, Indiana, 46260
Study site
Iowa City, Iowa, 52242-1089
Study site
Jacksonville Beach, Florida, 32250
Study site
Kalamazoo, Michigan, 49009
Study site
La Jolla, California, 92037
Study site
Lubbock, Texas, 79410
Study site
Mobile, Alabama, 36608
Study site
Mooresville, Indiana, 46158
Study site
Philadelphia, Pennsylvania, 19107
Study site
Phoenix, Arizona, 85023
Study site
Pittsburgh, Pennsylvania, 15213-2592
Study site
San Antonio, Texas, 78233
Study site
San Diego, California, 92123
Study site
Sarasota, Florida, 34239
Study site
St. Petersburg, Florida, 33703
Study site
Worcester, Massachusetts, 01655
Study site
Ypsilanti, Michigan, 48197
Canada12 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
Fredericton, New Brunswick, E3B 5N5
Study site
Guelph, Ontario, N1E 4J4
Study site
Halifax, Nova Scotia, B3H 3A7
Study site
Kelowna, British Columbia, V1Y 1T2
Study site
Kitchener, Ontario, N2G 1G3
Study site
London, Ontario, N6A 5A5
Study site
Oshawa, Ontario, L1G 2B9
Study site
Oshawa, Ontario, L1J 2J2
Study site
Québec, Quebec, G1L 3L5
Study site
Richmond Hill, Ontario, L4C 4Z3
Study site
Vancouver, British Columbia, V6Z 1Y6
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 and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery
The purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. Because of this, there is a need for drugs that will help slow the amount of bleeding during surgery.
- Conditions
- Blood Loss, Surgical
- Being tested
- Trasylol (Aprotinin, BAYA0128), Placebo
- Keywords
- Transfusion requirements, Hip replacement surgery, Prevention of blood loss, Bloodloss
- 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
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump
PlaceboDrug
A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump
| 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 subjects requiring a blood transfusion (predonated blood or packed red blood cells, autologous or allogenic) anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Measured: intra-op tp discharge
Secondary outcomes (8)
The percent of subjects 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 subjects 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
The estimated blood loss during surgery, drainage (in milliliters) from the operative site in the first six hours post-operatively, and total drainage until removal of drains.
Measured: surgery to discharge
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusion
Measured: pre-operative through day 2
Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.
Measured: surgery
Changes in blood markers related to inflammation and blood coagulation
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 posted28 Apr 2008 (estimated)
- Study startFeb 2005
- Primary completionJan 2006
- Study completionJan 2006
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
- 359 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
- NCT00668031
- Sponsor's protocol ID
- 11694
- Status last verified
- Dec 2014
- First submitted
- 22 Apr 2008
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 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 and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT00668031
- Acronym / sponsor ID
- 11694
- Conditions
- Blood Loss, Surgical
- Keywords
- Transfusion requirements, Hip replacement surgery, Prevention of blood loss, Bloodloss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 28 Apr 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 purpose of this study is to assess if aprotinin (BAY A0128), given intravenously during surgery, is safe and can help reduce the amount of bleeding and the need for a blood transfusion during hip replacement surgery. Patients undergoing major surgery are at risk for significant blood loss. Because of this, there is a need for drugs that will help slow the amount of bleeding during surgery.
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 (2 listed)
- Subjects requiring elective primary total hip replacement surgery
- Documented, signed, dated informed consent obtained prior to any study specific procedures being performed
Key exclusion criteria (5 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, subject should be excluded. If during cardiac surgery in the last 6 months, there is a record of aprotinin administration, subject should be excluded
- Subjects with a known or suspected allergy to aprotinin - Subjects with impaired renal function (serum creatinine > 3.5 mg/dl or 309 micromoles/liter)
- 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
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)A loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of aprotinin using an IV infusion pump | Drug | Arm 1 |
| PlaceboA loading dose IV infusion of 2,000,000 KIU (200 mL) followed by 500,000 KIU (50 mL) IV per hour until the end of surgery of of placebo using an IV infusion pump | Drug | Arm 2 |
Primary outcome
Percent of subjects requiring a blood transfusion (predonated blood or packed red blood cells, autologous or allogenic) anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge)
Time frame: intra-op tp discharge
8 secondary outcomes
The percent of subjects 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 subjects 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
The estimated blood loss during surgery, drainage (in milliliters) from the operative site in the first six hours post-operatively, and total drainage until removal of drains.
Time frame: surgery to discharge
The change from preoperative hemoglobin concentration to postoperative hemoglobin concentration (obtained in the morning of postoperative Day 2, or, if transfused earlier, prior to transfusion
Time frame: pre-operative through day 2
Surgeon's assessment of the degree to which bleeding obscures his/her view of the surgical field, relative to past, similar procedures.
Time frame: surgery
Changes in blood markers related to inflammation and blood coagulation
Time frame: surgery to discharge
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 30 Dec 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
40 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, run by Bayer at 40 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 2 inclusion and 5 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 30 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 40 sites in United States, Canada, Puerto Rico. 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 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?
Percent of subjects requiring a blood transfusion (predonated blood or packed red blood cells, autologous or allogenic) anytime in the intra-operative or post-operative period (up to the earlier of Day 7 or discharge) (time frame: intra-op tp 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 30 Dec 2014.