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Status unknownNCT01457586Updated Oct 24, 2011

Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

A Phase 4 interventional study of Blood transfusion and No blood transfusion in Heart Diseases, sponsored by Hospital Pitangueiras. Status unknown at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2011-10-24.

Sponsored by Hospital Pitangueiras · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Diseases

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Keywords

  • Heart Surgery
  • Blood Transfusion
  • Postoperative Complications
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 1,778 interventional studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Hospital Pitangueiras is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients who received blood transfusion previous to the heart surgery.
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Transfusion

    Patient who received blood transfusion in the perioperative period

    Biological: Blood transfusion

  • No intervention
    No Transfusion

    Patients who did not receive blood transfusion in the perioperative period

    Biological: No blood transfusion

Interventions

  • BiologicalBlood transfusion

    Blood transfusion in perioperative period.

  • BiologicalNo blood transfusion

    No transfusion in the perioperative period.

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What researchers measure

Primary outcomes

  1. Any postoperative complication

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

    Time frame: 1 month

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Study locations

1 of 1 sites recruiting
  • Hospital Pitangueiras
    Jundiai, Sao Paulo 1295, Brazil
    Recruiting
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References and documents

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. doi: 10.1177/026765919400900503. PubMed 7833539 ↗
  • 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. PubMed 10809262 ↗
  • 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. PubMed 8915216 ↗
  • 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. PubMed 9562283 ↗
  • 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. PubMed 10378555 ↗
  • 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. PubMed 12400765 ↗
  • 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. PubMed 21790520 ↗
  • 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. PubMed 21574966 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01457586
Lead sponsor
Hospital Pitangueiras
Responsible party
Roberto Rocha e Silva (MD PHD in Cardiac Surgery, Hospital Pitangueiras) — Principal investigator
First posted
Oct 24, 2011
Start date
Sep 2011
Primary completion
Sep 2013 (estimated)
Completion
Oct 2013 (estimated)
Last update
Oct 24, 2011

Study contacts

ROBERTO R Silva, MD PHD
Contact
rochaesilva@incor.usp.br
55-11-45215757
ROBERTO R Silva, MD PHD
principal investigator · Hospital Pitangueiras

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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