Conventional Versus Point-of-care Based Coagulation Management - Full Text View

Sponsor:	Johann Wolfgang Goethe University
Collaborator:	University Hospital, Essen
Information provided by:	Johann Wolfgang Goethe University
ClinicalTrials.gov Identifier:	NCT00997841

Purpose

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.

Condition	Intervention	Phase
Cardiac Surgery Coagulation Management	Procedure: Point-of-Care versus conventional coagulation management	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Conventional Versus Point-of-care Based Coagulation Management in Cardiac Surgery Patients Suffering From Increased Bleeding Tendency - a Prospective and Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Surgery

U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
POC algorithm: Active Comparator cardiac surgery patients suffering from increased perioperative bleeding and being treated following Point of Care based algorithm	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
conventional algorithm: Active Comparator cardiac surgery patients suffering from increased perioperative bleeding and being treated following conventional coagulation management algorithm	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997841

Contacts

Contact: Christian F Weber, Dr.	+4969630187466	christian.weber@kgu.de
Contact: Dirk Meininger, PhD	+496963015858	dirk.meininger@kgu.de

Locations

Germany
Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology	Recruiting
Frankfurt/Main, Germany, 60590
Contact: Christian F Weber, Dr. +4969630187466 christian.weber@kgu.de
Contact: Dirk Meininger, PhD +4969630187629 dirk.meininger@kgu.de
Principal Investigator: Christian F Weber, Dr.
University Hospital Essen, Clinic for Anesthesiology and Intensive Care Medicine	Active, not recruiting
Essen, Germany, 45473

Sponsors and Collaborators

Johann Wolfgang Goethe University

University Hospital, Essen

Investigators

Principal Investigator:

Christian F Weber, Dr.

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

More Information

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, 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.

Responsible Party:	Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany ( Dr. Christian Weber )
Study ID Numbers:	POC-9509
Study First Received:	October 18, 2009
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00997841 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University:

POC
ROTEM
Multiplate
bleeding tendency
coagulation management

amount of transfused red blood cell concentrates,
FFP
platelet concentrates
rate of rethoracotomy
ventilation time

ClinicalTrials.gov processed this record on February 08, 2010