Conventional Versus Point-of-care Based Coagulation Management

Study Overview
=================
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.

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

Conditions
-----------------
Cardiac Surgery, Coagulation Management

Intervention / Treatment
-----------------
* Procedure: Point-of-Care versus conventional coagulation management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years, combined surgical procedures (ACB & valve surgery), double valve surgery, aortic surgery, Re-Dos Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: POC algorithm<br>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<br>* 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<br>* Other names: Point-of-Care;|
| Active Comparator: conventional algorithm<br>cardiac surgery patients suffering from increased perioperative bleeding and being treated following conventional coagulation management algorithm | Procedure: Point-of-Care versus conventional coagulation management<br>* 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<br>* Other names: Point-of-Care;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
POC, ROTEM, Multiplate, bleeding tendency, coagulation management, amount of transfused red blood cell concentrates,, FFP, platelet concentrates, rate of rethoracotomy, ventilation time