Estudio aleatorizado, doble ciego y controlado sobre la eficacia de la albúmina y manitol en el cebado del sistema de circulación extracorpórea en cirugía cardiaca para reducir el sangrado postoperatorio y las necesidades transfusionalesA randomized, double-blind, controlled trial on efficacy of priming the cardiopulmonary bypass with albumin and mannitol to reduce postoperative bleeding and transfusional requirements

• Conditions: Cardiac surgery with cardiopulmonary bypass. Postoperative bleeding and requirements of blood products; MedDRA version: 9.1Level: LLTClassification code 10066123Term: Cardiopulmonary bypass; MedDRA version: 9.1Level: LLTClassification code 10036277Term: Postoperative bleeding; MedDRA version: 9.1Level: LLTClassification code 10005765Term: Blood product transfusion

• Registration Number: EUCTR2008-008009-23-ES
• Lead Sponsor: Servicio de Anestesia-Reanimación

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-30
• Last Update Posted: 18 March 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Programmed cardiac surgery, age over 18 years, patients given full informed consent, stay at ICU at least 48 h.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Thoracic aortic surgery
- Severe hepatic failure (Child grades B-C)
- Severe renal failure (basal serum creatinine >2 mg/dL, glomerular filtration rate <30 mL/min/m2)
- Coagulopathy or platetlet count <150.000/mm3
- Antiagregant platelet treatment in the 72 h before surgery
- Treatment with low molecular weight heparin in the 12 h before surgery or unfracttionated heparin in the 4 h before surgery
- Preoperative anemia (hemoglobin below 12 g/dL in women and 13 g/dL in men)
- Use of inotropes or intraaortic contrapulsation in preoperative period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified