Conventional Versus Point-of-care Based Coagulation Management

This study has been completed.

Sponsor:

Collaborator:

University Hospital, Essen

Information provided by:

Goethe University

ClinicalTrials.gov Identifier:

NCT00997841

First received: October 18, 2009

Last updated: May 3, 2010

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2009

Last Updated Date

May 3, 2010

Start Date ^ICMJE

June 2009

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

amount of transfused red blood cell concentrates [ Time Frame: 24 h after begin of surgical intervention ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00997841 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

other transfused blood products including FFP, platelet concentrates and coagulation factor concentrates [ Time Frame: 24h after surgical intervention ] [ Designated as safety issue: No ]
rate of rethoracotomy for bleeding [ Time Frame: 24h after surgical intervention ] [ Designated as safety issue: No ]
ventilation time on ICU [ Time Frame: till discharge from ICU ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Conventional Versus Point-of-care Based Coagulation Management

Official Title ^ICMJE

Conventional Versus Point-of-care Based Coagulation Management in Cardiac Surgery Patients Suffering From Increased Bleeding Tendency - a Prospective and Randomized Study

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic

Condition ^ICMJE

Cardiac Surgery
Coagulation Management

Intervention ^ICMJE

Procedure: 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

Other Names:

ROTEM
Multiplate
Point-of-Care

Study Arm (s)

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

Intervention: Procedure: Point-of-Care versus conventional coagulation management
Active Comparator: conventional algorithm
cardiac surgery patients suffering from increased perioperative bleeding and being treated following conventional coagulation management algorithm

Intervention: Procedure: Point-of-Care versus conventional coagulation management

Publications *

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.
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.
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.
Weber CF, Görlinger 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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

none

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00997841

Other Study ID Numbers ^ICMJE

POC-9509

Has Data Monitoring Committee

Responsible Party

Dr. Christian Weber, Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany

Study Sponsor ^ICMJE

Goethe University

Collaborators ^ICMJE

University Hospital, Essen

Investigators ^ICMJE

Principal Investigator:

Christian F Weber, Dr.

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

Information Provided By

Goethe University

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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