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 transfusionales A randomized, double-blind, controlled trial on efficacy of priming the cardiopulmonary bypass with albumin and mannitol to reduce postoperative bleeding and transfusional requirements

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-008009-23-ES

Enrollment

134

Registered

2010-04-30

Start date

2009-03-23

Completion date

Unknown

Last updated

2013-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: human albumin Product Name: human albumin Pharmaceutical Form: Intravenous infusion Other descriptive name: HUMAN ALBUMIN SOLUTION Concentration unit: % percent Concentration type: equal C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To examine de effect of a priming solution in cardiopulmonary bypass pump containing albumin, Ringer lactate and mannitol vs Ringer lactate (control) on postoperative bleeding and blood product requirements ;Secondary Objective: To examine the effect of this priming on: - Fluid balance - Coagulation and hematology parameters - Reexploration because bleeding - Stay on ICU and hospital;Primary end point(s): - Blood volume drainage in the first 24 h - Rate of patients who required any blood product in the first 48 h - Number of units of packed reed blood cells, plasma or platelets administered in the first 48 h	—

Measure

Time frame

Main Objective: To examine de effect of a priming solution in cardiopulmonary bypass pump containing albumin, Ringer lactate and mannitol vs Ringer lactate (control) on postoperative bleeding and blood product requirements ;Secondary Objective: To examine the effect of this priming on: - Fluid balance - Coagulation and hematology parameters - Reexploration because bleeding - Stay on ICU and hospital;Primary end point(s): - Blood volume drainage in the first 24 h - Rate of patients who required any blood product in the first 48 h - Number of units of packed reed blood cells, plasma or platelets administered in the first 48 h

—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026