Clinical Details
Official title: Indicación de transfusión de Hemoderivados en el Postoperatorio de cirugía Cardiaca Tras la implantación de un Sistema de monitorización de la coagulación a la Cabecera Del Paciente: Tromboelastometría Versus Protocolo Habitual de transfusión
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: median transfusion of packed red cells per patient
Secondary outcome: rate transfusion of platelets pool and plasma pool
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female patients
- over 18 years
- undergoing cardiac surgery
- with cardiopulmonary bypass
- bleed excessively
As it is not possible to predict in advance who will bleed, informed consent will be
required for all patients over 18 who are to undergo cardiac surgery with CPB.
Will be randomized to either group
1. Those patients with diffuse bleeding after protamine administration. and / or
2. They bleed excessively after surgery. Are excessive bleeding criteria: the debit ≥
300ml drains in the first hour; ≥ 250ml in the second hour or ≥ 150ml at any later
time. Consider that the patient is bleeding excessively when the drains debit is
<150ml.
Exclusion Criteria:
- Patients <18 years
- Extracorporeal circulation surgery
- Surgery with Mini extracorporeal circulation (MECC)
- Refuse to participate in the study.
Locations and Contacts
Additional Information
Starting date: February 2010
Last updated: August 8, 2013