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

October 18, 2009
May 3, 2010
June 2009
April 2010   (final data collection date for primary outcome measure)
amount of transfused red blood cell concentrates [ Time Frame: 24 h after begin of surgical intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00997841 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Conventional Versus Point-of-care Based Coagulation Management
Conventional Versus Point-of-care Based Coagulation Management in Cardiac Surgery Patients Suffering From Increased Bleeding Tendency - a Prospective and Randomized Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
  • Cardiac Surgery
  • Coagulation Management
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: 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • none
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00997841
POC-9509
No
Dr. Christian Weber, Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany
Goethe University
University Hospital, Essen
Principal Investigator: Christian F Weber, Dr. Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology, Intensive Care Medicine and Pain Therapy
Goethe University
October 2009

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