Cardiac SurgeryAPACHENCT04804345
AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
An observational study of Cardiac Surgery and Cardiopulmonary Bypass, run by University Hospital, Bordeaux at 7 sites in France.
Trial summary
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Cardiopulmonary Bypass, High Risk Bleeding
- Type of treatment
- Injection or infusion
- How many people
- 693 participants
- Where
- 7 sitesFrance
- Study dates
- 31 Mar 2021to 31 Aug 2021
- Phase
- Observational
- 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
Study population: consecutive patients undergoing cardiac surgery with a high risk of hemorrhage who have received a prophylactic infusion of either tranexamic acid or aprotinin and meeting the protocol criteria between july 2017 and october 2020 in seven university hospital centers.
Who may be able to join
- patients undergoing cardiac on pump surgery at high risk for bleeding defined by :
- Aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (Primary or redo)
- Heart transplant (Primary or Redo)
- Infectious endocarditis (Primary or Redo)
- Ascending acute aortic dissection (Primary or Redo)
- Artificial heart / LVAD under CEC (Primary or Redo)
- Combined surgery, Redo
- Ascending aorta surgery, Redo
Who cannot join
- Off pump cardiac surgery
- Patient not meeting the inclusion criteria
- Patient not receiving antifibrinolytic therapy
- Patient with absolute contraindication to antifibrinolytics,
- Patient refusing to give access to their medical chart,
- Patient not meeting the inclusion criteria
- Patient protected by the law, under guardianship or trusteeship,
- Patient deprived of liberty
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Grenoble University Hospital
La Tronche, 38700
Lyon University Hospital
Lyon, 69500
Montpellier University Hospital
Montpellier, 34295
Nantes University Hospital
Nantes, 44093
North Val de Seine Paris University Hospital
Paris, 75877
Georges Pompidou European University Hospital
Paris, 75908
Bordeaux University Hospital
Pessac, 33604
About this study
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.
Read the detailed description
Perioperative bleeding remains a real challenge for physicians managing cardiac surgical patients. In patients at high risk for excessive bleeding the prophylactic use of antifibrinolytics may be useful. This study propose to compare the efficacity and innocuity of aprotinin and tranexamic acid to reduce the proportion of patient presenting severe peri-operative bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification.
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, High Risk Bleeding
- Being tested
- standard of care
- Keywords
- cardiac surgery, cardiopulmonary bypass, massive peri-operative bleeding, antifibrinolytics, blood products transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
retrospective study: standard of care
| Study group | Role | What they receive |
|---|---|---|
| The aprotinin group, | all patients receiving a first infusion 1M KIU before surgical incision followed by a steady dose of 250 000 KIU/h with an additional dose of 1M KIU added to the cardiopulmonary bypass unit. Receives: Other: standard of care | |
| The tranexamic acid group | all patient receiving tranexamic acid following each local center standarded protocol Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with severe peri-operative bleeding
Proportion of patients with severe peri-operative bleeding defined by an UDPB (the Universal Definition of Perioperative Bleeding ) classification of 3 and 4.
Measured: day 30 after surgery
Secondary outcomes (21)
distribution of patients by UDPB classification category
proportion of patients with category 0 UDPB.
Measured: day 30 after surgery
distribution of patients by UDPB classification category
proportion of patients with category 1 UDPB.
Measured: day 30 after surgery
distribution of patients by UDPB classification category
proportion of patients with category 2 UDPB.
Measured: day 30 after surgery
distribution of patients by UDPB classification category
proportion of patients with category 3 UDPB.
Measured: day 30 after surgery
distribution of patients by UDPB classification category
proportion of patients with category 4 UDPB.
Measured: day 30 after surgery
blood loss
post operative chest tube blood loss
Measured: 24 hours after chest closure
rescue surgery for bleeding
proportion of rescue surgery for bleeding
Measured: day 30 after surgery
length of stay
intensive care unit length of stay
Measured: through intensive care unit discharge, an average of 30 days
length of stay
hospital length of stay
Measured: through hospital discharge, an average of 30 days
KDIGO score greater than or equal to 2
acute kidney injury defined by KDIGO score greater than or equal to 2
Measured: day 7 after surgery
mechanical ventilation time
duration of artificial ventilation (hours)
Measured: through intensive care unit discharge, an average of 30 days
mechanical ventilation
need to use mechanical ventilation for more than 48 hours
Measured: 48 hours after surgery
need for transfusion
need for labil blood products and medicinal products derived from blood
Measured: up to 48 hours after surgery
need for transfusion
need for labil blood products and medicinal products derived from blood
Measured: up to seven day after surgery
need for vasopressors/inotropes
need for use postoperative vasopressors/inotropes for more than 24 hours
Measured: beyond 24 hours after surgery
vital status
mortality after surgery
Measured: 30 days after surgery
new renal replacement therapy
need for renal replacement therapy
Measured: up to day 30 after surgery
short term mechanical circulatory support
need for short term mechanical circulatory support (extra corporeal life support, Impella TM pump, intra aortic balloon pump)
Measured: up to 30 day after surgery
myocardial infarction
occurrence of myocardial infarction
Measured: up to 30 day after surgery
embolic or thrombotic event
occurrence of embolic or thrombotic event
Measured: up to 30 day after surgery
stroke
occurrence of stroke
Measured: up to 30 day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start31 Mar 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre OUATTARA, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804345
- Sponsor's protocol ID
- CHUBX 2020/67
- Acronym
- APACHE
- Status last verified
- Mar 2022
- First submitted
- 10 Mar 2021
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AProtinin Versus Tranexamic Acid in Cardiac Surgery Patients With High-risk for Excessive Bleeding
- ClinicalTrials.gov ID
- NCT04804345
- Acronym / sponsor ID
- APACHE / CHUBX 2020/67
- Conditions
- Cardiac Surgery, Cardiopulmonary Bypass, High Risk Bleeding
- Keywords
- cardiac surgery, cardiopulmonary bypass, massive peri-operative bleeding, antifibrinolytics, blood products transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- 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.
In this before-after multicenter study the authors tested the hypothesis that the prophylactic use of aprotinin compared to tranexamic acid could reduce the proportion of patients presenting severe perioperative bleeding.
Detailed description
Perioperative bleeding remains a real challenge for physicians managing cardiac surgical patients. In patients at high risk for excessive bleeding the prophylactic use of antifibrinolytics may be useful. This study propose to compare the efficacity and innocuity of aprotinin and tranexamic acid to reduce the proportion of patient presenting severe peri-operative bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The aprotinin group, | – | Other: standard of careall patients receiving a first infusion 1M KIU before surgical incision followed by a steady dose of 250 000 KIU/h with an additional dose of 1M KIU added to the cardiopulmonary bypass unit. |
| The tranexamic acid group | – | Other: standard of careall patient receiving tranexamic acid following each local center standarded protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients undergoing cardiac surgery with a high risk of hemorrhage who have received a prophylactic infusion of either tranexamic acid or aprotinin and meeting the protocol criteria between july 2017 and october 2020 in seven university hospital centers.
Key inclusion criteria (8 listed)
- Aorto-coronary bypasses surgery (2 or more) under dual platelet aggregation therapy (Primary or redo)
- Heart transplant (Primary or Redo)
- Infectious endocarditis (Primary or Redo)
- Ascending acute aortic dissection (Primary or Redo)
- Artificial heart / LVAD under CEC (Primary or Redo)
Key exclusion criteria (8 listed)
- Off pump cardiac surgery
- Patient not meeting the inclusion criteria
- Patient not receiving antifibrinolytic therapy
- Patient with absolute contraindication to antifibrinolytics,
- Patient refusing to give access to their medical chart,
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 |
|---|---|---|
| standard of careretrospective study: standard of care | Other | The aprotinin group,, The tranexamic acid group |
Primary outcome
Proportion of patients with severe peri-operative bleeding
Time frame: day 30 after surgery
Proportion of patients with severe peri-operative bleeding defined by an UDPB (the Universal Definition of Perioperative Bleeding ) classification of 3 and 4.
21 secondary outcomes
distribution of patients by UDPB classification category
Time frame: day 30 after surgery
distribution of patients by UDPB classification category
Time frame: day 30 after surgery
distribution of patients by UDPB classification category
Time frame: day 30 after surgery
distribution of patients by UDPB classification category
Time frame: day 30 after surgery
distribution of patients by UDPB classification category
Time frame: day 30 after surgery
blood loss
Time frame: 24 hours after chest closure
rescue surgery for bleeding
Time frame: day 30 after surgery
length of stay
Time frame: through intensive care unit discharge, an average of 30 days
length of stay
Time frame: through hospital discharge, an average of 30 days
KDIGO score greater than or equal to 2
Time frame: day 7 after surgery
mechanical ventilation time
Time frame: through intensive care unit discharge, an average of 30 days
mechanical ventilation
Time frame: 48 hours after surgery
need for transfusion
Time frame: up to 48 hours after surgery
need for transfusion
Time frame: up to seven day after surgery
need for vasopressors/inotropes
Time frame: beyond 24 hours after surgery
vital status
Time frame: 30 days after surgery
new renal replacement therapy
Time frame: up to day 30 after surgery
short term mechanical circulatory support
Time frame: up to 30 day after surgery
myocardial infarction
Time frame: up to 30 day after surgery
embolic or thrombotic event
Time frame: up to 30 day after surgery
stroke
Time frame: up to 30 day after surgery
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 3 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Cardiac Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
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
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
Alexandre OUATTARA, MD, PhD principal investigator
University Hospital, Bordeaux
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Cardiopulmonary Bypass, run by University Hospital, Bordeaux at 7 sites in France.
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 8 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: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. 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.
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?
Proportion of patients with severe peri-operative bleeding (time frame: day 30 after surgery). 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 3 Mar 2022.