Conventional Versus Point-of-care Based Coagulation Management

NCT ID: NCT00997841

Last Updated: 2010-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-04-30

Brief Summary

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The purpose of the study is to determine the efficacy of two different algorithms for coagulation management in patients undergoing cardiac surgery suffering from increased bleeding tendency. Algorithm 1 is based on conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration,...) and Algorithm 2 is based on thrombelastometry using the ROTEM-device and impedance aggregometry using the Multiplate device.

Detailed Description

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Conditions

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Cardiac Surgery Coagulation Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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POC algorithm

cardiac surgery patients suffering from increased perioperative bleeding and being treated following Point of Care based algorithm

Group Type ACTIVE_COMPARATOR

Point-of-Care versus conventional coagulation management

Intervention Type PROCEDURE

Patients are randomized to receive either point-of-care based or conventional coagulation measurements based coagulation therapy in the case of increased perioperative bleeding tendency

conventional algorithm

cardiac surgery patients suffering from increased perioperative bleeding and being treated following conventional coagulation management algorithm

Group Type ACTIVE_COMPARATOR

Point-of-Care versus conventional coagulation management

Intervention Type PROCEDURE

Patients are randomized to receive either point-of-care based or conventional coagulation measurements based coagulation therapy in the case of increased perioperative bleeding tendency

Interventions

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Point-of-Care versus conventional coagulation management

Patients are randomized to receive either point-of-care based or conventional coagulation measurements based coagulation therapy in the case of increased perioperative bleeding tendency

Intervention Type PROCEDURE

Other Intervention Names

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ROTEM Multiplate Point-of-Care

Eligibility Criteria

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Inclusion Criteria

* age \> 18 years, combined surgical procedures (ACB \& valve surgery), double valve surgery, aortic surgery, Re-Dos

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany

Principal Investigators

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Christian F Weber, Dr.

Role: PRINCIPAL_INVESTIGATOR

Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology, Intensive Care Medicine and Pain Therapy

Locations

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University Hospital Essen, Clinic for Anesthesiology and Intensive Care Medicine

Essen, , Germany

Site Status

Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology

Frankfurt am Main, , Germany

Site Status

Countries

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Germany

References

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Görlinger K, Jambor C, Hanke A, Adamzik M, Hartmann M, Rahe-Meyer N. Thrombelastometry and impedance aggregometry based algorithm for coagulation management in cardiac surgery. Intensive Care Med 33: 196, 2007.

Reference Type BACKGROUND

Görlinger K, Jambor C, Hanke A, Adamzik M, Hartmann M, Rahe-Meyer N. Perioperative coagulation management and controll of platelet transfusion by point-of-care platelet function analysis. Transfus Med Hemother 34: 396-411, 2007.

Reference Type BACKGROUND

Görlinger K, Bergmann L, Hartmann M, Marggraf G, Kamler M, Müller-Beißenhirtz H. Reduction of blood transfusion rate by thrombelastometry and impedance aggregometry based point-of-care coagulation management in thoracic and cardiovascular surgery. Appl Cardiopulmon Pathophysiol 13: 174-7, 2009.

Reference Type BACKGROUND

Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.

Reference Type DERIVED
PMID: 22914710 (View on PubMed)

Other Identifiers

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POC-9509

Identifier Type: -

Identifier Source: org_study_id

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