Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hemostatic Disorders

Intervention / Treatment
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* Procedure: Group ROTEM
* Other: Group C


Participation Criteria
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Eligibility Criteria
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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 Those patients with diffuse bleeding after protamine administration. and / or 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group C<br>• conventional protocol, volume replacement with massive bleeding. | Other: Group C<br>* 10 min. after protamine administration, if there is a significant diffuse microvascular bleeding or when the patient departure from surgery if bleeds excessively will be a TCA and routed the following analytical results: prothrombin time, activated partial thromboplastin time, platelet count and fibrinogen. If any of the determinations altered and the patient still bleeding, apply the standard protocol of the unit. 10 minutes after each treatment was performed new laboratory tests to analyze the result.<br>|
| Experimental: Group ROTEM<br>• Protocol according to the different tests to be performed with thromboelastography | Procedure: Group ROTEM<br>* 10 min after administration of protamine, if there is a large diffuse microvascular bleeding or bleed excessively at the exit of surgery then will check an Intem, a Heptem a Extem and Fibtem. If any of the determinations altered and the patient leaves still bleeding apply the proposed treatment algorithm for Rotem. 10 minutes after each treatment will take the test again indicated that treatment, to ensure that the defect has been corrected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median transfusion of packed red cells per patient |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate transfusion of platelets pool and plasma pool |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemostatic disorders, ardiac surgery, cardiopulmonary bypass