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OpenTrials
Completed

NCT Number: NCT00997841

Conventional Versus Point-of-care Based Coagulation Management

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.

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Key information

Conditions

Cardiac Surgery Cardiovascular Diseases Coagulation Management Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Point-of-Care versus conventional coagulation management

Procedure

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

Other names: ROTEM, Multiplate, Point-of-Care

Primary outcomes

  1. amount of transfused red blood cell concentrates

    Time frame: 24 h after begin of surgical intervention

Secondary outcomes

  1. other transfused blood products including FFP, platelet concentrates and coagulation factor concentrates

    Time frame: 24h after surgical intervention

  2. rate of rethoracotomy for bleeding

    Time frame: 24h after surgical intervention

  3. ventilation time on ICU

    Time frame: till discharge from ICU

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • University Hospital, Essen

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2009
Registry last updated
May 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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