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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
  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 4

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

U.S. FDA Resources

Further study details as provided by 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
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: POC algorithm
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
Other Names:
  • ROTEM
  • Multiplate
  • Point-of-Care
Active Comparator: conventional algorithm
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
Other Names:
  • ROTEM
  • Multiplate
  • Point-of-Care

  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

Locations
Germany
University Hospital Essen, Clinic for Anesthesiology and Intensive Care Medicine
Essen, Germany, 45473
Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology
Frankfurt/Main, Germany, 60590
Sponsors and Collaborators
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, 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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Christian Weber, Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany
ClinicalTrials.gov Identifier: NCT00997841     History of Changes
Other Study ID Numbers: POC-9509
Study First Received: October 18, 2009
Last Updated: May 3, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Goethe University:
POC
ROTEM
Multiplate
bleeding tendency
coagulation management
 amount of transfused red blood cell concentrates,
FFP
platelet concentrates
rate of rethoracotomy
ventilation time

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
 Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 19, 2013