Clinical trial NCT01919840: Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hemostatic Disorders
Keywords: hemostatic disorders
ardiac surgery
cardiopulmonary bypass
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Main objective:

Determine whether by introducing thromboelastograph, the investigators reduced the number of packed red cells received by each patient (median) compared to the usual protocol, in which the indication for transfusion is based on laboratory tests: Prothrombin time, time activated partial thromboplastin time, thrombin, reptilase, fibrinogen and platelet contage.

Design:

Prospective randomized controlled trial and single blinded.

Disease or disorder under study:

Study of coagulopathy in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB).

Primary endpoint:

median transfusion of packed red blood cells per patient. Study population Male and female patients over 18 years undergoing cardiac surgery with cardiopulmonary bypass to bleed excessively.

Duration of treatment:

The coagulation monitoring methods tested are made from protamine administration to CEC output if a) the patient bleeds diffusely, or b) from arrival in the unit if not satisfied critics a) bleed excessively drains and until the patient stops bleeding (debit drains \<a 150ml / h).


Eligibility 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.

Primary outcomes:
measure: median transfusion of packed red cells per patient
timeFrame: 24 hours
Secondary outcomes:
measure: rate transfusion of platelets pool and plasma pool
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Pilar Paniagua, MD
role: PRINCIPAL_INVESTIGATOR
References: