Postoperative; Dysfunction Following Cardiac SurgeryCGRCardNCT01915654
Impact of RBC Transfusion Less Than 14 Days on Morbidity and Mortality in Cardiac Surgical Patients
An observational study of Postoperative; Dysfunction Following Cardiac Surgery and Transfusion Related Complication, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The purpose of the transfusion of packed red blood cell is to overcome acute or chronic anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase oxygen delivery to peripheral tissues. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative; Dysfunction Following Cardiac Surgery, Transfusion Related Complication
- What is being tested?
- study population
- Type of treatment
- Surgery or procedure
- How many people
- 459 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Dec 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study involves patients operated in the cardiothoracic and ardio-vascular surgery department of Besançon University Hospital between December 2008 and May 2009 (study population) or from December 2007 to May 2008 and from December 2009 to May 2010 (reference population).
Who may be able to join
- Patients male or female over the age of 18 years
- Patients able to understand the benefits and risks of testing
- For the study population: patients who underwent cardiac surgery (all surgery combined) scheduled or emergency December 2008 to May 2009, having been transfused intraoperatively and until the seventh postoperative day .
- For the reference population: patients who have undergone elective or emergency cardiac surgery from December 2007 to May 2008 and from December 2009 to May 2010, having been transfused intraoperatively and until the seventh postoperative day.
Who cannot join
- Inability to understand the advantages and disadvantages of the study, psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study.
- Patients who have expressed opposition to his participation in the study.
- For the study population: patients were transfused within seven days before the start of the observation period.
- For the study population: patients with transfusion of red blood cell more than 14 days
- For the reference population: patients were transfused within seven days before surgery.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Besançon
Besançon, France, Besançon
About this study
Official title: Impact de la Transfusion de Culots Globulaires de Moins de 14 Jours Sur la Morbi-mortalité Chez Des Patients en Chirurgie Cardiaque
The purpose of the transfusion of packed red blood cell is to overcome acute or chronic anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field particularly favorable to the development of tissue hypoxia, which is associated with increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues at the preoperative period is accompanied by a significant reduction of these major complications.
Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious effect of transfusion, especially in patients with poor condition, related to storage time. Indeed, during storage, impaired blood-related storage is created. It is metabolic, biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery where patients are suitable for transfusion RBC, have focused on the effect of transfusions on consumption and the transport of oxygen to demonstrate the impact of conservation lesions on their role in vivo. In particular, a single-center retrospective American study showed reduction of postoperative complications in patients who received RBC under 14 days.
However one of the confounding factors present is that all transfused RBCs are not leukoreduced (unlike the French transfusion policy). In addition, the greater part of the clinical studies are controversial. That is why we aim to assess, through a retrospective study of data, the impact of transfusion of red red blood cells within 14 days of post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac surgery patients.
- Being tested
- study population
- Keywords
- Cardiac surgery, Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study populationProcedure or surgery
Population of patients undergoing cardiac surgery between December 2008 and May 2009, with pellets transfused RBCs stored for less than 14 days
| Study group | Role | What they receive |
|---|---|---|
| Study population | The study involves patients operated in the cardiothoracic and cardio-vascular surgery department of Besançon University Hospital between December 2008 and May 2009 (study population) or between December 2007 and May 2008 and between December 2009 and May 2010 (reference population). Receives: Procedure: study population | |
| Reference population | The study involves patients operated in the cardiothoracic and cardio-vascular surgery department of Besançon University Hospital between December 2008 and May 2009 (study population) or between December 2007 and May 2008 and between December 2009 and May 2010 (reference population). |
What is being measured
The primary outcome is the main question the study is designed to answer.
death / acute renal failure / operating / stroke / postoperative ischemia post infection
The primary endpoint was the occurrence of death and / or acute renal failure and / or operating and / or stroke and / or postoperative ischemia post infection, in-beyond the 48th hour of the transfusion.
Measured: in-beyond the 48th hour of the transfusion
Secondary outcomes (1)
Mortality / average length of stay in intensive care / resuscitation (> 48 hours) / the average length of stay in cardiac surgery
The secondary endpoints were mortality at 30 days, the average length of stay in intensive care / resuscitation (> 48 hours) and (> 15 days).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionDec 2013
Why it stopped: Retrospective study from December 2007 to May 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative; Dysfunction Following Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Flicoteaux, Principal investigator, CHRU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915654
- Sponsor's protocol ID
- P/2013/194
- Acronym
- CGRCard
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2013
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact de la Transfusion de Culots Globulaires de Moins de 14 Jours Sur la Morbi-mortalité Chez Des Patients en Chirurgie Cardiaque
- ClinicalTrials.gov ID
- NCT01915654
- Acronym / sponsor ID
- CGRCard / P/2013/194
- Keywords
- Cardiac surgery, Transfusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Retrospective study from December 2007 to May 2010
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Aug 2013 (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 the transfusion of packed red blood cell is to overcome acute or chronic anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field particularly favorable to the development of tissue hypoxia, which is associated with increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues at the preoperative period is accompanied by a significant reduction of these major complications.
Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious effect of transfusion, especially in patients with poor condition, related to storage time. Indeed, during storage, impaired blood-related storage is created. It is metabolic, biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery where patients are suitable for transfusion RBC, have focused on the effect of transfusions on consumption and the transport of oxygen to demonstrate the impact of conservation lesions on their role in vivo. In particular, a single-center retrospective American study showed reduction of postoperative complications in patients who received RBC under 14 days.
However one of the confounding factors present is that all transfused RBCs are not leukoreduced (unlike the French transfusion policy). In addition, the greater part of the clinical studies are controversial. That is why we aim to assess, through a retrospective study of data, the impact of transfusion of red red blood cells within 14 days of post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac surgery patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Procedure: study populationThe study involves patients operated in the cardiothoracic and cardio-vascular surgery department of Besançon University Hospital between December 2008 and May 2009 (study population) or between December 2007 and May 2008 and between December 2009 and May 2010 (reference population). |
| Reference population | – | –The study involves patients operated in the cardiothoracic and cardio-vascular surgery department of Besançon University Hospital between December 2008 and May 2009 (study population) or between December 2007 and May 2008 and between December 2009 and May 2010 (reference population). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study involves patients operated in the cardiothoracic and ardio-vascular surgery department of Besançon University Hospital between December 2008 and May 2009 (study population) or from December 2007 to May 2008 and from December 2009 to May 2010 (reference population).
Key inclusion criteria (4 listed)
- Patients male or female over the age of 18 years
- Patients able to understand the benefits and risks of testing
- For the study population: patients who underwent cardiac surgery (all surgery combined) scheduled or emergency December 2008 to May 2009, having been transfused intraoperatively and until the seventh postoperative day .
- For the reference population: patients who have undergone elective or emergency cardiac surgery from December 2007 to May 2008 and from December 2009 to May 2010, having been transfused intraoperatively and until the seventh postoperative day.
Key exclusion criteria (5 listed)
- Inability to understand the advantages and disadvantages of the study, psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study.
- Patients who have expressed opposition to his participation in the study.
- For the study population: patients were transfused within seven days before the start of the observation period.
- For the study population: patients with transfusion of red blood cell more than 14 days
- For the reference population: patients were transfused within seven days before surgery.
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 |
|---|---|---|
| study populationPopulation of patients undergoing cardiac surgery between December 2008 and May 2009, with pellets transfused RBCs stored for less than 14 days | Procedure or surgery | Study population |
Primary outcome
death / acute renal failure / operating / stroke / postoperative ischemia post infection
Time frame: in-beyond the 48th hour of the transfusion
The primary endpoint was the occurrence of death and / or acute renal failure and / or operating and / or stroke and / or postoperative ischemia post infection, in-beyond the 48th hour of the transfusion.
1 secondary outcome
Mortality / average length of stay in intensive care / resuscitation (> 48 hours) / the average length of stay in cardiac surgery
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Retrospective study from December 2007 to May 2010). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
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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.
Guillaume Flicoteaux principal investigator
CHRU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative; Dysfunction Following Cardiac Surgery and Transfusion Related Complication, run by Centre Hospitalier Universitaire de Besancon at 1 site 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 4 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: stopped early, as of the sponsor's last update on 22 Jul 2016. 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 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 was stopped early (reason given: Retrospective study from December 2007 to May 2010). 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?
death / acute renal failure / operating / stroke / postoperative ischemia post infection (time frame: in-beyond the 48th hour of the transfusion). 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 22 Jul 2016.