Heart DiseasesPhase 4NCT01457586
Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
A Phase 4 study testing Blood transfusion and No blood transfusion in people with Heart Diseases, run by Hospital Pitangueiras at 1 site in Brazil.
Trial summary
Observational Study of Hemoderivative Transfusion Imputable Complications in Initial Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Blood transfusion and No blood transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2011to Oct 2013
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with acquired heart disease with indication for surgery and who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day.
Who cannot join
- Patients who received blood transfusion previous to the heart surgery.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Pitangueiras
Jundiaí, São Paulo, 1295
Ricardo De Mola, MD, 55-11-45276226, ricardo_485@terra.com.br
Ricardo De Mola, MD
About this study
Official title: Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
Observational Study of Hemoderivative Transfusion Imputable Complications in Initial Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day.
Blood transfusion might be only a marker of the patient severity.
Read the detailed description
Criteria for blood transfusion during extra corporeal circulation (if used) is volume expansion need leading to a predictable hematocrit lower than 25%.
Criteria for blood transfusion after extra corporeal circulation or in the postoperative period is a hematocrit below 30% with signs of low cardiac output due to hypovolemia.
- Conditions
- Heart Diseases
- Being tested
- Blood transfusion, No blood transfusion
- Keywords
- Heart Surgery, Blood Transfusion, Postoperative Complications
- Medical subject headings
- Heart Diseases, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood transfusionBiological
Blood transfusion in perioperative period.
No blood transfusionBiological
No transfusion in the perioperative period.
| Study group | Role | What they receive |
|---|---|---|
| Transfusion | Active comparator | Patient who received blood transfusion in the perioperative period Receives: Biological: Blood transfusion |
| No Transfusion | No intervention | Patients who did not receive blood transfusion in the perioperative period Receives: Biological: No blood transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any postoperative complication
Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Pitangueiras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Rocha e Silva, Hospital Pitangueiras
- Investigators
- ROBERTO R Silva, MD PHD, Principal investigator, Hospital Pitangueiras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457586
- Sponsor's protocol ID
- Heart surgery hemoderivatives
- Status last verified
- Oct 2011
- First submitted
- 19 Oct 2011
- Last updated
- 24 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ranucci M, Pavesi M, Mazza E, Bertucci C, Frigiola A, Menicanti L, Ditta A, Boncilli A, Conti D. Risk factors for renal dysfunction after coronary surgery: the role of cardiopulmonary bypass technique. Perfusion. 1994;9(5):319-26. doi: 10.1177/026765919400900503.
PubMed 7833539Leal-Noval SR, Marquez-Vacaro JA, Garcia-Curiel A, Camacho-Larana P, Rincon-Ferrari MD, Ordonez-Fernandez A, Flores-Cordero JM, Loscertales-Abril J. Nosocomial pneumonia in patients undergoing heart surgery. Crit Care Med. 2000 Apr;28(4):935-40. doi: 10.1097/00003246-200004000-00004.
PubMed 10809262Zacharias A, Habib RH. Factors predisposing to median sternotomy complications. Deep vs superficial infection. Chest. 1996 Nov;110(5):1173-8. doi: 10.1378/chest.110.5.1173.
PubMed 8915216Michalopoulos A, Stavridis G, Geroulanos S. Severe sepsis in cardiac surgical patients. Eur J Surg. 1998 Mar;164(3):217-22. doi: 10.1080/110241598750004670.
PubMed 9562283Michalopoulos A, Tzelepis G, Dafni U, Geroulanos S. Determinants of hospital mortality after coronary artery bypass grafting. Chest. 1999 Jun;115(6):1598-603. doi: 10.1378/chest.115.6.1598.
PubMed 10378555Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002 Oct;74(4):1180-6. doi: 10.1016/s0003-4975(02)03766-9.
PubMed 12400765Hung M, Besser M, Sharples LD, Nair SK, Klein AA. The prevalence and association with transfusion, intensive care unit stay and mortality of pre-operative anaemia in a cohort of cardiac surgery patients. Anaesthesia. 2011 Sep;66(9):812-8. doi: 10.1111/j.1365-2044.2011.06819.x. Epub 2011 Jul 25.
PubMed 21790520Dardashti A, Ederoth P, Algotsson L, Bronden B, Luhrs C, Bjursten H. Blood transfusion after cardiac surgery: is it the patient or the transfusion that carries the risk? Acta Anaesthesiol Scand. 2011 Sep;55(8):952-61. doi: 10.1111/j.1399-6576.2011.02445.x. Epub 2011 May 16.
PubMed 21574966
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
- ClinicalTrials.gov ID
- NCT01457586
- Acronym / sponsor ID
- Heart surgery hemoderivatives
- Conditions
- Heart Diseases
- Keywords
- Heart Surgery, Blood Transfusion, Postoperative Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hospital PitangueirasUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 24 Oct 2011 (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.
Observational Study of Hemoderivative Transfusion Imputable Complications in Initial Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day.
Blood transfusion might be only a marker of the patient severity.
Detailed description
Criteria for blood transfusion during extra corporeal circulation (if used) is volume expansion need leading to a predictable hematocrit lower than 25%.
Criteria for blood transfusion after extra corporeal circulation or in the postoperative period is a hematocrit below 30% with signs of low cardiac output due to hypovolemia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfusion | Active comparator | Biological: Blood transfusionPatient who received blood transfusion in the perioperative period |
| No Transfusion | No intervention | Biological: No blood transfusionPatients who did not receive blood transfusion in the perioperative period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with acquired heart disease with indication for surgery and who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day.
Key exclusion criteria (1 listed)
- Patients who received blood transfusion previous to the heart 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 |
|---|---|---|
| Blood transfusionBlood transfusion in perioperative period. | Biological | Transfusion |
| No blood transfusionNo transfusion in the perioperative period. | Biological | No Transfusion |
Primary outcome
Any postoperative complication
Time frame: 1 month
Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2011.
- Background: PubMed 7833539Ranucci M, Pavesi M, Mazza E, Bertucci C, Frigiola A, Menicanti L, Ditta A, Boncilli A, Conti D. Risk factors for renal dysfunction after coronary surgery: the role of cardiopulmonary bypass technique. Perfusion. 1994;9(5):319-26. doi: 10.1177/026765919400900503.
- Background: PubMed 10809262Leal-Noval SR, Marquez-Vacaro JA, Garcia-Curiel A, Camacho-Larana P, Rincon-Ferrari MD, Ordonez-Fernandez A, Flores-Cordero JM, Loscertales-Abril J. Nosocomial pneumonia in patients undergoing heart surgery. Crit Care Med. 2000 Apr;28(4):935-40. doi: 10.1097/00003246-200004000-00004.
- Background: PubMed 8915216Zacharias A, Habib RH. Factors predisposing to median sternotomy complications. Deep vs superficial infection. Chest. 1996 Nov;110(5):1173-8. doi: 10.1378/chest.110.5.1173.
- Background: PubMed 9562283Michalopoulos A, Stavridis G, Geroulanos S. Severe sepsis in cardiac surgical patients. Eur J Surg. 1998 Mar;164(3):217-22. doi: 10.1080/110241598750004670.
- Background: PubMed 10378555Michalopoulos A, Tzelepis G, Dafni U, Geroulanos S. Determinants of hospital mortality after coronary artery bypass grafting. Chest. 1999 Jun;115(6):1598-603. doi: 10.1378/chest.115.6.1598.
- Background: PubMed 12400765Engoren MC, Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ. Effect of blood transfusion on long-term survival after cardiac operation. Ann Thorac Surg. 2002 Oct;74(4):1180-6. doi: 10.1016/s0003-4975(02)03766-9.
- Background: PubMed 21790520Hung M, Besser M, Sharples LD, Nair SK, Klein AA. The prevalence and association with transfusion, intensive care unit stay and mortality of pre-operative anaemia in a cohort of cardiac surgery patients. Anaesthesia. 2011 Sep;66(9):812-8. doi: 10.1111/j.1365-2044.2011.06819.x. Epub 2011 Jul 25.
- Background: PubMed 21574966Dardashti A, Ederoth P, Algotsson L, Bronden B, Luhrs C, Bjursten H. Blood transfusion after cardiac surgery: is it the patient or the transfusion that carries the risk? Acta Anaesthesiol Scand. 2011 Sep;55(8):952-61. doi: 10.1111/j.1399-6576.2011.02445.x. Epub 2011 May 16.
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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.
ROBERTO R Silva, MD PHD principal investigator
Hospital Pitangueiras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood transfusion and No blood transfusion in people with Heart Diseases, run by Hospital Pitangueiras at 1 site in Brazil.
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 1 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 24 Oct 2011. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact ROBERTO R Silva, MD PHD (55-11-45215757, rochaesilva@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any postoperative complication (time frame: 1 month). 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 NCT01457586, which also lists 8 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 24 Oct 2011.