Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Heart Diseases Clinical Trial

Official title:

Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01457586
• Other study ID #: Heart surgery hemoderivatives
• Status: Recruiting
• Phase: Phase 4
• First received: October 19, 2011
• Last updated: October 21, 2011
• Start date: September 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2011
• Source: Hospital Pitangueiras
• Contact: ROBERTO R Silva, MD PHD
• Phone: 55-11-45215757
• Email: rochaesilva[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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 day.

Blood transfusion might be only a marker of the patient severity.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Biological:
• Blood transfusion
Blood transfusion in perioperative period.
• No blood transfusion
No transfusion in the perioperative period.

Locations

Country	Name	City	State
Brazil	Hospital Pitangueiras	Jundiai	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Pitangueiras

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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 Sep;55(8):952-61. doi: 10.1111/j.1399-6576.2011.02445.x. Epub 2011 May 16. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any postoperative complication	Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.	1 month	Yes