Bleeding and Cardiac SurgeryPhase 3NCT00396760
Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery
A Phase 3 study testing aprotinin or tranexamic acid in people with Bleeding and Cardiac Surgery and Allogeneic Blood Transfusion, run by German Heart Center at 1 site in Germany.
Trial summary
The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.Only patients undergoing first time CABG or first time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding and Cardiac Surgery, Allogeneic Blood Transfusion, Aortic Valve Replacement
- What is being tested?
- aprotinin or tranexamic acid
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Jul 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
- informed consent
- Patients undergoing primary CABG or Aortic valve replacement surgery
Who cannot join
- Previous sternotomy
- OPCAB surgery
- urgent/emergency operation
- Coumadin treatment
- previous aprotinin exposure
- preoperative renal impairment (Creatinine > 2 mg/dL)
- patients refusing blood transfusions
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of High-Dose Aprotinin and Tranexamic Acid on Bleeding Tendency and Allogeneic Blood Transfusion in Patients Undergoing Primary Aortic Valve Replacement or Coronary Artery Revascularization
The hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.Only patients undergoing first time CABG or first time aortic valve replacement are included in this study.
Read the detailed description
Excessive bleeding during and after cardiac surgery is a serious complication. It exposes patients to the risk of allogeneic blood transfusion or other blood products and the risk of mediastinal re-exploration.Antifibrinolytic drugs like aprotinin and tranexamic acid are proven to reduce bleeding tendency and transfusion requirement in cardiac surgery. The efficacy of these drugs is proven, especially for the unspecific proteinase inhibitor aprotinin, however, there are concerns about the safety and the high costs of this drug. There are only limited head-to-head comparisons of these two drugs.
In this double-blind, prospective, controlled study the efficacy of aprotinin and tranexamic acid is compared. Primary outcome is the 24 hours postoperative drainage blood loss and the percentage of patients requiring allogeneic blood transfusion during the hospital stay. Subgroups of patients undergoing CABG surgery or aortic valve replacement are predefined for combined and separate data analysis.The power of the study is calculated for this subgroup-analysis.
Secondary outcome measurements are molecular marker of activation of hemostasis up to the 5th postoperative day.
- Conditions
- Bleeding and Cardiac Surgery, Allogeneic Blood Transfusion, Aortic Valve Replacement, Coronary Artery Bypass Graft Surgery
- Being tested
- aprotinin or tranexamic acid
- Keywords
- cardiac surgery, blood transfusion, antifibrinolytics, aprotinin, tranexamic acid
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprotinin or tranexamic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours postoperative drainage blood loss
incidence of allogeneic blood transfusion
Secondary outcomes (2)
activation of fibrinolysis and hemostasis
impairment of renal function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startJan 2005
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bleeding and Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- German Heart Center
- Sponsor type
- University, hospital or other
- Investigators
- Wulf Dietrich, MD, PhD, Principal investigator, Department of Anesthesiology, German Heart Center Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396760
- Sponsor's protocol ID
- 1172/04
- Status last verified
- Nov 2006
- First submitted
- 6 Nov 2006
- Last updated
- 7 Nov 2006
- Results posted
- No
Publications
Diprose P, Herbertson MJ, O'Shaughnessy D, Deakin CD, Gill RS. Reducing allogeneic transfusion in cardiac surgery: a randomized double-blind placebo-controlled trial of antifibrinolytic therapies used in addition to intra-operative cell salvage. Br J Anaesth. 2005 Mar;94(3):271-8. doi: 10.1093/bja/aei044. Epub 2004 Dec 10.
PubMed 15591329Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. doi: 10.1002/14651858.CD001886.
PubMed 11279735Royston D, Levy JH, Fitch J, Dietrich W, Body SC, Murkin JM, Spiess BD, Nadel A. Full-dose aprotinin use in coronary artery bypass graft surgery: an analysis of perioperative pharmacotherapy and patient outcomes. Anesth Analg. 2006 Nov;103(5):1082-8. doi: 10.1213/01.ane.0000238447.74029.f5.
PubMed 17056936Dietrich W, Busley R, Kriner M. High-dose aprotinin in cardiac surgery: is high-dose high enough? An analysis of 8281 cardiac surgical patients treated with aprotinin. Anesth Analg. 2006 Nov;103(5):1074-81. doi: 10.1213/01.ane.0000238446.30034.c8.
PubMed 17056935Lison S, Dietrich W, Braun S, Boehm J, Schuster T, Englhard A, Perchuc A, Spannagl M, Busley R. Enhanced thrombin generation after cardiopulmonary bypass surgery. Anesth Analg. 2011 Jan;112(1):37-45. doi: 10.1213/ANE.0b013e3181fc6df0. Epub 2010 Dec 2.
PubMed 21127274Dietrich W, Spannagl M, Boehm J, Hauner K, Braun S, Schuster T, Busley R. Tranexamic acid and aprotinin in primary cardiac operations: an analysis of 220 cardiac surgical patients treated with tranexamic acid or aprotinin. Anesth Analg. 2008 Nov;107(5):1469-78. doi: 10.1213/ane.0b013e318182252b.
PubMed 18931201
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of High-Dose Aprotinin and Tranexamic Acid on Bleeding Tendency and Allogeneic Blood Transfusion in Patients Undergoing Primary Aortic Valve Replacement or Coronary Artery Revascularization
- ClinicalTrials.gov ID
- NCT00396760
- Acronym / sponsor ID
- 1172/04
- Conditions
- Bleeding and Cardiac Surgery, Allogeneic Blood Transfusion, Aortic Valve Replacement, Coronary Artery Bypass Graft Surgery
- Keywords
- cardiac surgery, blood transfusion, antifibrinolytics, aprotinin, tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants
- Lead sponsor
- German Heart CenterUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jul 2006
- First posted
- 7 Nov 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 hypothesis of this study is that the antifibrinolytic drugs aprotinin and tranexamic acid equally influence bleeding tendency and transfusion requirement in patients undergoing first time cardiac procedures with a low risk of increased postoperative bleeding.Only patients undergoing first time CABG or first time aortic valve replacement are included in this study.
Detailed description
Excessive bleeding during and after cardiac surgery is a serious complication. It exposes patients to the risk of allogeneic blood transfusion or other blood products and the risk of mediastinal re-exploration.Antifibrinolytic drugs like aprotinin and tranexamic acid are proven to reduce bleeding tendency and transfusion requirement in cardiac surgery. The efficacy of these drugs is proven, especially for the unspecific proteinase inhibitor aprotinin, however, there are concerns about the safety and the high costs of this drug. There are only limited head-to-head comparisons of these two drugs.
In this double-blind, prospective, controlled study the efficacy of aprotinin and tranexamic acid is compared. Primary outcome is the 24 hours postoperative drainage blood loss and the percentage of patients requiring allogeneic blood transfusion during the hospital stay. Subgroups of patients undergoing CABG surgery or aortic valve replacement are predefined for combined and separate data analysis.The power of the study is calculated for this subgroup-analysis.
Secondary outcome measurements are molecular marker of activation of hemostasis up to the 5th postoperative day.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent
- Patients undergoing primary CABG or Aortic valve replacement surgery
Key exclusion criteria (8 listed)
- Previous sternotomy
- OPCAB surgery
- urgent/emergency operation
- Coumadin treatment
- previous aprotinin exposure
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 or tranexamic acid | Drug | – |
Primary outcome
24 hours postoperative drainage blood loss
incidence of allogeneic blood transfusion
2 secondary outcomes
activation of fibrinolysis and hemostasis
impairment of renal function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2006.
- Background: PubMed 15591329Diprose P, Herbertson MJ, O'Shaughnessy D, Deakin CD, Gill RS. Reducing allogeneic transfusion in cardiac surgery: a randomized double-blind placebo-controlled trial of antifibrinolytic therapies used in addition to intra-operative cell salvage. Br J Anaesth. 2005 Mar;94(3):271-8. doi: 10.1093/bja/aei044. Epub 2004 Dec 10.
- Background: PubMed 11279735Henry DA, Moxey AJ, Carless PA, O'Connell D, McClelland B, Henderson KM, Sly K, Laupacis A, Fergusson D. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2001;(1):CD001886. doi: 10.1002/14651858.CD001886.
- Background: PubMed 17056936Royston D, Levy JH, Fitch J, Dietrich W, Body SC, Murkin JM, Spiess BD, Nadel A. Full-dose aprotinin use in coronary artery bypass graft surgery: an analysis of perioperative pharmacotherapy and patient outcomes. Anesth Analg. 2006 Nov;103(5):1082-8. doi: 10.1213/01.ane.0000238447.74029.f5.
- Background: PubMed 17056935Dietrich W, Busley R, Kriner M. High-dose aprotinin in cardiac surgery: is high-dose high enough? An analysis of 8281 cardiac surgical patients treated with aprotinin. Anesth Analg. 2006 Nov;103(5):1074-81. doi: 10.1213/01.ane.0000238446.30034.c8.
- Derived from this study: PubMed 21127274Lison S, Dietrich W, Braun S, Boehm J, Schuster T, Englhard A, Perchuc A, Spannagl M, Busley R. Enhanced thrombin generation after cardiopulmonary bypass surgery. Anesth Analg. 2011 Jan;112(1):37-45. doi: 10.1213/ANE.0b013e3181fc6df0. Epub 2010 Dec 2.
- Derived from this study: PubMed 18931201Dietrich W, Spannagl M, Boehm J, Hauner K, Braun S, Schuster T, Busley R. Tranexamic acid and aprotinin in primary cardiac operations: an analysis of 220 cardiac surgical patients treated with tranexamic acid or aprotinin. Anesth Analg. 2008 Nov;107(5):1469-78. doi: 10.1213/ane.0b013e318182252b.
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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.
Wulf Dietrich, MD, PhD principal investigator
Department of Anesthesiology, German Heart Center Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aprotinin or tranexamic acid in people with Bleeding and Cardiac Surgery and Allogeneic Blood Transfusion, run by German Heart Center at 1 site in Germany.
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 8 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 7 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
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?
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?
24 hours postoperative drainage blood loss. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396760, which also lists 6 linked publications.
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 7 Nov 2006.