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OpenTrials
Completed

NCT Number: NCT01837758

Monitoring Platelet Function During Continuous Hemodialysis

Aim of the study is a description of changes in platelet function during continuous veno-venous hemodialysis or hemofiltration in patients on an intensive care unit using the Multiplate system.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Johann Wolfgang Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Need for a continuous renal replacement therapy
  • Platelet Count >100.000/nl

Exclusion criteria

  • Pregnancy
  • Age <18 years
  • Renal replacement therapy within the 7 days prior to enrollment

Treatment and study plan

Primary outcomes

  1. ASPItest

    Time frame: Baseline, 6, 12, 24 and 48 hours

    Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.

Secondary outcomes

  1. ADPtest

    Time frame: Baseline, 6, 12, 24 and 48 hours

    Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.

  2. TRAPtest

    Time frame: Baseline, 6, 12, 24, 48 hours

    Area under the aggregation curve (AUC) after platelet stimulation with thrombin-receptor-activating peptide 6 (TRAP-6) at baseline and 6, 12, 24 and 48 hours after the start of the continuous hemofiltration.

  3. CT-INTEM

    Time frame: Baseline, 6, 12, 24 and 48 hours

    Clotting time (CT) in the intrinsically activated rotational thrombelastometry (ROTEM) recorded in seconds at baseline and 6, 12, 24 and 48 hours after the start of continuous veno-venous hemofiltration.

  4. MCF-INTEM

    Time frame: Baseline, 6, 12, 24 and 48hours

    Maximum clot firmness (MCF) in the intrinsically activated rotational thrombelastometry (ROTEM) recorded in millimeters at baseline and 6, 12, 24 and 48 hours after the start of continuous veno-venous hemofiltration.

Other outcomes

  1. Age

    Time frame: Baseline

    Age of the patient at the point of enrollment

  2. Height

    Time frame: Baseline

    Height of the patient measured in centimeters.

  3. Weight

    Time frame: Baseline

    Weight of the patient measured in kilograms.

  4. Gender

    Time frame: Baseline

  5. ASA-Classification

    Time frame: Baseline

    The ASA-Classification will be determined preoperatively.

  6. Antiaggregatory Premedication

    Time frame: Baseline

    Antiaggregatory medication taken prior to enrollment wil be recorded in the categories aspirin, clopidogrel, ticagrelor, cumarins and others.

  7. Dialysis filter

    Time frame: Basline

    The brand of filter used for the hemofiltration or hemodialysis will be registered.

  8. Anticoagulation for hemofiltration

    Time frame: Baseline

    The anticoagulation used for hemofiltration will be recorded in the categories heparin and calcium citrate.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Official study title

Changes in Platelet Function During Continuous Veno-venous Hemodialysis Using the Multiplate Device

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2013
Registry last updated
Mar 3, 2017

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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