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

NCT01919840 | Terminated Phase 4

• 1 other identifier: IIBSP-ROT-2010-15
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• median transfusion of packed red cells per patient

  24 hours

Secondary Outcomes (1)

• rate transfusion of platelets pool and plasma pool

  24 hours

Study Arms (2)

Group C

ACTIVE COMPARATOR

• conventional protocol, volume replacement with massive bleeding.

Other: Group C

Group ROTEM

EXPERIMENTAL

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

Procedure: Group ROTEM

Interventions

Group ROTEM 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.

Group ROTEM

Group C 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 C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients \<18 years
• Extracorporeal circulation surgery
• Surgery with Mini extracorporeal circulation (MECC)
• Refuse to participate in the study.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Pilar Paniagua, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: August 9, 2013
• Study Start: February 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 9, 2013

Record last verified: 2013-08