Conventional Versus Point-of-care Based Coagulation Management

Phase 4

Completed

• Conditions: Cardiac Surgery; Coagulation Management
• Interventions: Procedure: Point-of-Care versus conventional coagulation management

• Registration Number: NCT00997841
• Lead Sponsor: Goethe University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Status Verified: 2009-10
• Study First Submitted: 2009-10-18
• Study First Submitted QC: 2009-10-18
• Study First Posted: 2009-10-19
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Last Update Submitted: 2010-05-03
• Last Update Posted: 2010-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POC algorithm	Point-of-Care versus conventional coagulation management	cardiac surgery patients suffering from increased perioperative bleeding and being treated following Point of Care based algorithm
conventional algorithm	Point-of-Care versus conventional coagulation management	cardiac surgery patients suffering from increased perioperative bleeding and being treated following conventional coagulation management algorithm

Primary Outcome Measures

Name	Time	Method
amount of transfused red blood cell concentrates	24 h after begin of surgical intervention

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University Hospital Essen, Clinic for Anesthesiology and Intensive Care Medicine; 🇩🇪 Essen, Germany

Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology; 🇩🇪 Frankfurt/Main, Germany