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Completed

NCT Number: NCT00998647

Modified Ultrafiltration in Cardiac Surgery

The purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.

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Key information

Conditions

Coagulopathy Blood Loss Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Rethoracotomy Transfusion Requirements Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Goethe University hospital, Clinic for Anaesthesioloy

Frankfurt am Main, 60590, Germany

About this study

The impact of modified ultrafiltration following extracorporeal circulation on primary and secondary hemostasis is controversial. In this study we intend to assess both, primary and secondary hemostasis prior to and after the usage of modified ultrafiltration. Primary hemostasis is assessed using Multiple Electrode Aggregometry (Multiplate) and secondary hemostasis is assessed performing thrombelastometry using the ROTEM device. Patients are preoperatively randomized to receive either modified ultrafiltration or no filtration.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing complex cardiac surgery procedures

Exclusion criteria

  • none

Treatment and study plan

modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus

Device

usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids

Other names: Maquet haemoconcentrator, BC 20 plus

Primary outcomes

  1. ex vivo platelet aggregation (TRAPtest)

    Time frame: 20 min after filtration

Secondary outcomes

  1. secondary hemostasis assessed by ROTEM

    Time frame: 20 min before and after filtration

  2. blood loss

    Time frame: 24 h after filtration

  3. kind and number of transfused blood products

    Time frame: 24h after filtration

  4. conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration)

    Time frame: 20 min before and after filtration

  5. rate of rethoracotomy for bleeding

    Time frame: 24h after filtration

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Assessment of the Influence of Modified Ultrafiltration on Primary and Secondary Hemostasis in Cardiac Surgery Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 20, 2009
Registry last updated
Apr 23, 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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