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Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

NCT ID: NCT01457586

Last Updated: 2011-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-10-31

Brief Summary

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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

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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

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Heart Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Transfusion

Patient who received blood transfusion in the perioperative period

Group Type ACTIVE_COMPARATOR

Blood transfusion

Intervention Type BIOLOGICAL

Blood transfusion in perioperative period.

No Transfusion

Patients who did not receive blood transfusion in the perioperative period

Group Type NO_INTERVENTION

No blood transfusion

Intervention Type BIOLOGICAL

No transfusion in the perioperative period.

Interventions

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Blood transfusion

Blood transfusion in perioperative period.

Intervention Type BIOLOGICAL

No blood transfusion

No transfusion in the perioperative period.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patients who received blood transfusion previous to the heart surgery.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Pitangueiras

OTHER

Sponsor Role lead

Responsible Party

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Roberto Rocha e Silva

MD PHD in Cardiac Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ROBERTO R Silva, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Hospital Pitangueiras

Locations

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Hospital Pitangueiras

Jundiaí, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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ROBERTO R Silva, MD PHD

Role: CONTACT

[email protected]
55-11-45215757

Facility Contacts

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Ricardo De Mola, MD

Role: primary

[email protected]
55-11-45276226

References

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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.

Reference Type BACKGROUND
PMID: 7833539 (View on PubMed)

Leal-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.

Reference Type BACKGROUND
PMID: 10809262 (View on PubMed)

Zacharias 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.

Reference Type BACKGROUND
PMID: 8915216 (View on PubMed)

Michalopoulos A, Stavridis G, Geroulanos S. Severe sepsis in cardiac surgical patients. Eur J Surg. 1998 Mar;164(3):217-22. doi: 10.1080/110241598750004670.

Reference Type BACKGROUND
PMID: 9562283 (View on PubMed)

Michalopoulos 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.

Reference Type BACKGROUND
PMID: 10378555 (View on PubMed)

Engoren 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.

Reference Type BACKGROUND
PMID: 12400765 (View on PubMed)

Hung 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.

Reference Type BACKGROUND
PMID: 21790520 (View on PubMed)

Dardashti 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.

Reference Type BACKGROUND
PMID: 21574966 (View on PubMed)

Other Identifiers

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Heart surgery hemoderivatives

Identifier Type: -

Identifier Source: org_study_id