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

NCT ID: NCT01919840

Last Updated: 2013-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-09-30

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).

Conditions

Hemostatic Disorders

Keywords

hemostatic disorders; ardiac surgery; cardiopulmonary bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group C

• conventional protocol, volume replacement with massive bleeding.

Group Type: ACTIVE_COMPARATOR

Group C

Intervention Type: OTHER

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.

Group ROTEM

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

Group Type: EXPERIMENTAL

Group ROTEM

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pilar Paniagua, MD

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

IIBSP-ROT-2010-15

Identifier Type: -

Identifier Source: org_study_id