Conventional Versus Point-of-care Based Coagulation Management

Cardiac Surgery Clinical Trial

Official title:

Conventional Versus Point-of-care Based Coagulation Management in Cardiac Surgery Patients Suffering From Increased Bleeding Tendency - a Prospective and Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997841
• Other study ID #: POC-9509
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2009
• Last updated: May 3, 2010
• Start date: June 2009
• Est. completion date: April 2010

Study information

• Verified date: October 2009
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Coagulation Management

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Essen, Clinic for Anesthesiology and Intensive Care Medicine	Essen
Germany	Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology	Frankfurt/Main

Sponsors (2)

Lead Sponsor	Collaborator
Goethe University	University Hospital, Essen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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.

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, 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of transfused red blood cell concentrates		24 h after begin of surgical intervention	No
Secondary	other transfused blood products including FFP, platelet concentrates and coagulation factor concentrates		24h after surgical intervention	No
Secondary	rate of rethoracotomy for bleeding		24h after surgical intervention	No
Secondary	ventilation time on ICU		till discharge from ICU	No