Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

This study is currently recruiting participants.

Verified October 2011 by Hospital Pitangueiras

Sponsor:

Information provided by (Responsible Party):

Roberto Rocha e Silva, Hospital Pitangueiras

ClinicalTrials.gov Identifier:

NCT01457586

First received: October 19, 2011

Last updated: October 21, 2011

Last verified: October 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Heart Diseases	Biological: Blood transfusion Biological: No blood transfusion	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Resource links provided by NLM:

MedlinePlus related topics: Blood Transfusion and Donation Heart Diseases Heart Surgery

U.S. FDA Resources

Further study details as provided by Hospital Pitangueiras:

Primary Outcome Measures:

Any postoperative complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.

Estimated Enrollment:	200
Study Start Date:	September 2011
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Transfusion Patient who received blood transfusion in the perioperative period	Biological: Blood transfusion Blood transfusion in perioperative period.
No Intervention: No Transfusion Patients who did not receive blood transfusion in the perioperative period	Biological: No blood transfusion No transfusion in the perioperative period.

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457586

Contacts

Contact: ROBERTO R Silva, MD PHD

55-11-45215757

rochaesilva@incor.usp.br

Locations

Brazil
Hospital Pitangueiras	Recruiting
Jundiai, Sao Paulo, Brazil, 1295
Contact: Ricardo De Mola, MD 55-11-45276226 ricardo_485@terra.com.br
Sub-Investigator: Ricardo De Mola, MD

Sponsors and Collaborators

Hospital Pitangueiras

Investigators

Principal Investigator:

ROBERTO R Silva, MD PHD

Hospital Pitangueiras

More Information

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.

Leal-Noval SR, Marquez-Vácaro JA, García-Curiel A, Camacho-Laraña P, Rincón-Ferrari MD, Ordoñez-Fernández A, Flores-Cordero JM, Loscertales-Abril J. Nosocomial pneumonia in patients undergoing heart surgery. Crit Care Med. 2000 Apr;28(4):935-40.

Zacharias A, Habib RH. Factors predisposing to median sternotomy complications. Deep vs superficial infection. Chest. 1996 Nov;110(5):1173-8.

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

Michalopoulos A, Tzelepis G, Dafni U, Geroulanos S. Determinants of hospital mortality after coronary artery bypass grafting. Chest. 1999 Jun;115(6):1598-603.

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.

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. Epub 2011 Jul 25.

Dardashti A, Ederoth P, Algotsson L, Brondén B, Lührs C, Bjursten H. Blood transfusion after cardiac surgery: is it the patient or the transfusion that carries the risk? Acta Anaesthesiol Scand. 2011 May 16; [Epub ahead of print]

Responsible Party:	Roberto Rocha e Silva, MD PHD in Cardiac Surgery, Hospital Pitangueiras
ClinicalTrials.gov Identifier:	NCT01457586 History of Changes
Other Study ID Numbers:	Heart surgery hemoderivatives
Study First Received:	October 19, 2011
Last Updated:	October 21, 2011
Health Authority:	Brazil: Ethics Committee

Keywords provided by Hospital Pitangueiras:

Heart Surgery
Blood Transfusion
Postoperative Complications

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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