search
Back to results

Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Primary Purpose

Heart Diseases

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Blood transfusion
No blood transfusion
Sponsored by
Hospital Pitangueiras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Diseases focused on measuring Heart Surgery, Blood Transfusion, Postoperative Complications

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital PitangueirasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Transfusion

No Transfusion

Arm Description

Patient who received blood transfusion in the perioperative period

Patients who did not receive blood transfusion in the perioperative period

Outcomes

Primary Outcome Measures

Any postoperative complication
Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2011
Last Updated
October 21, 2011
Sponsor
Hospital Pitangueiras
search

1. Study Identification

Unique Protocol Identification Number
NCT01457586
Brief Title
Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
Official Title
Observational Study of Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Pitangueiras

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases
Keywords
Heart Surgery, Blood Transfusion, Postoperative Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transfusion
Arm Type
Active Comparator
Arm Description
Patient who received blood transfusion in the perioperative period
Arm Title
No Transfusion
Arm Type
No Intervention
Arm Description
Patients who did not receive blood transfusion in the perioperative period
Intervention Type
Biological
Intervention Name(s)
Blood transfusion
Intervention Description
Blood transfusion in perioperative period.
Intervention Type
Biological
Intervention Name(s)
No blood transfusion
Intervention Description
No transfusion in the perioperative period.
Primary Outcome Measure Information:
Title
Any postoperative complication
Description
Postoperative complication up to 1 month. Comparison between patients who did or did not receive blood transfusion.
Time Frame
1 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ROBERTO R Silva, MD PHD
Phone
55-11-45215757
Email
rochaesilva@incor.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ROBERTO R Silva, MD PHD
Organizational Affiliation
Hospital Pitangueiras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pitangueiras
City
Jundiai
State/Province
Sao Paulo
ZIP/Postal Code
1295
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo De Mola, MD
Phone
55-11-45276226
Email
ricardo_485@terra.com.br
First Name & Middle Initial & Last Name & Degree
Ricardo De Mola, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
7833539
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. doi: 10.1177/026765919400900503.
Results Reference
background
PubMed Identifier
10809262
Citation
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.
Results Reference
background
PubMed Identifier
8915216
Citation
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.
Results Reference
background
PubMed Identifier
9562283
Citation
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.
Results Reference
background
PubMed Identifier
10378555
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. doi: 10.1378/chest.115.6.1598.
Results Reference
background
PubMed Identifier
12400765
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. doi: 10.1016/s0003-4975(02)03766-9.
Results Reference
background
PubMed Identifier
21790520
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.
Results Reference
background
PubMed Identifier
21574966
Citation
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.
Results Reference
background

Learn more about this trial

Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

We'll reach out to this number within 24 hrs