Clinical trial NCT00997841: Conventional Versus Point-of-care Based Coagulation Management
Official title: Conventional Versus Point-of-care Based Coagulation Management in Cardiac Surgery Patients Suffering From Increased Bleeding Tendency - a Prospective and Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Surgery
Coagulation Management
Keywords: POC
ROTEM
Multiplate
bleeding tendency
coagulation management
amount of transfused red blood cell concentrates,
FFP
platelet concentrates
rate of rethoracotomy
ventilation time
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: University Hospital, Essen
First posted: 2009-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: amount of transfused red blood cell concentrates
timeFrame: 24 h after begin of surgical intervention
Secondary outcomes:
measure: other transfused blood products including FFP, platelet concentrates and coagulation factor concentrates
timeFrame: 24h after surgical intervention
measure: rate of rethoracotomy for bleeding
timeFrame: 24h after surgical intervention
measure: ventilation time on ICU
timeFrame: till discharge from ICU
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen, Clinic for Anesthesiology and Intensive Care Medicine
city: Frankfurt/Main
country: Germany
facility: Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology
Study officials:
affiliation: Johann Wolfgang Goethe University Frankfurt, Clinic for Anaesthesiology, Intensive Care Medicine and Pain Therapy
name: Christian F Weber, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.