Conventional Versus Point-of-care Based Coagulation Management

Goethe University

Status and phase: Completed; Phase 4

Conditions: Cardiac Surgery; Coagulation Management

Treatments: Procedure: Point-of-Care versus conventional coagulation management

Study type: Interventional

Funder types: Other

Identifiers

NCT00997841

POC-9509

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• none

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

POC algorithm

Active Comparator group

Description:

cardiac surgery patients suffering from increased perioperative bleeding and being treated following Point of Care based algorithm

Treatment:

Procedure: Point-of-Care versus conventional coagulation management

conventional algorithm

Active Comparator group

Description:

cardiac surgery patients suffering from increased perioperative bleeding and being treated following conventional coagulation management algorithm

Treatment:

Procedure: Point-of-Care versus conventional coagulation management