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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery; Coagulation Management
• Intervention / Treatment: Procedure: Point-of-Care versus conventional coagulation management

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
amount of transfused red blood cell concentrates	24 h after begin of surgical intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: University Hospital, Essen
• Investigators: Principal Investigator: Christian F Weber, Dr., Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology, Intensive Care Medicine and Pain Therapy

Publications and helpful links

General 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, Gorlinger 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. doi: 10.1097/ALN.0b013e318264c644.

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: October 18, 2009
• First Submitted That Met QC Criteria: October 18, 2009
• First Posted (Estimate): October 19, 2009

Study Record Updates

• Last Update Posted (Estimate): May 4, 2010
• Last Update Submitted That Met QC Criteria: May 3, 2010
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: platelet concentrates; ROTEM; Multiplate; FFP; POC; ventilation time; bleeding tendency; coagulation management; amount of transfused red blood cell concentrates,; rate of rethoracotomy
• Other Study ID Numbers: POC-9509