Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 24, 2011
October 1, 2011
2 years
October 19, 2011
October 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Any postoperative complication
Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.
1 month
Study Arms (2)
Transfusion
ACTIVE COMPARATORPatient who received blood transfusion in the perioperative period
No Transfusion
NO INTERVENTIONPatients who did not receive blood transfusion in the perioperative period
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients who received blood transfusion previous to the heart surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Pitangueiras
Jundiaí, São Paulo, 1295, Brazil
Related Publications (8)
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.
PMID: 7833539BACKGROUNDLeal-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.
PMID: 10809262BACKGROUNDZacharias 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.
PMID: 8915216BACKGROUNDMichalopoulos A, Stavridis G, Geroulanos S. Severe sepsis in cardiac surgical patients. Eur J Surg. 1998 Mar;164(3):217-22. doi: 10.1080/110241598750004670.
PMID: 9562283BACKGROUNDMichalopoulos 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.
PMID: 10378555BACKGROUNDEngoren 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.
PMID: 12400765BACKGROUNDHung 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.
PMID: 21790520BACKGROUNDDardashti 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.
PMID: 21574966BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ROBERTO R Silva, MD PHD
Hospital Pitangueiras
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PHD in Cardiac Surgery
Study Record Dates
First Submitted
October 19, 2011
First Posted
October 24, 2011
Study Start
September 1, 2011
Primary Completion
September 1, 2013
Study Completion
October 1, 2013
Last Updated
October 24, 2011
Record last verified: 2011-10