Blood Products Transfusion in Cardiac Surgery After the Implementation of a Coagulation Monitoring System at Patient Bedside: Thromboelastometry Versus Standard Transfusion Protocol (ROTEM-2010)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status and phase: Terminated; Phase 4

Conditions: Hemostatic Disorders

Treatments: Procedure: Group ROTEM; Other: Group C

Study type: Interventional

Funder types: Other

Identifiers

NCT01919840

IIBSP-ROT-2010-15

Details and patient eligibility

About

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).

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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49 participants in 2 patient groups

Group C

Active Comparator group

Description:

• conventional protocol, volume replacement with massive bleeding.

Treatment:

Other: Group C

Group ROTEM

Experimental group

Description:

• Protocol according to the different tests to be performed with thromboelastography

Treatment:

Procedure: Group ROTEM