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

Hemostatic Disorders Clinical Trial

— ROTEM-2010  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01919840
• Other study ID #: IIBSP-ROT-2010-15
• Status: Terminated
• Phase: Phase 4
• First received: April 12, 2013
• Last updated: August 8, 2013
• Start date: February 2010
• Est. completion date: September 2011

Study information

• Verified date: August 2013
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Procedure:
• Group ROTEM
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.

Other:
• Group C
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median transfusion of packed red cells per patient		24 hours	No
Secondary	rate transfusion of platelets pool and plasma pool		24 hours	No