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Conventional Versus Point-of-care Based Coagulation Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00997841
First Posted: October 19, 2009
Last Update Posted: May 4, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Essen
Information provided by:
Goethe University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


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 ]

Secondary Outcome Measures:
  • other transfused blood products including FFP, platelet concentrates and coagulation factor concentrates [ Time Frame: 24h after surgical intervention ]
  • rate of rethoracotomy for bleeding [ Time Frame: 24h after surgical intervention ]
  • ventilation time on ICU [ Time Frame: till discharge from ICU ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

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
First Submitted: October 18, 2009
First Posted: October 19, 2009
Last Update Posted: May 4, 2010
Last Verified: October 2009

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