NCT01837758

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

April 16, 2013

Last Update Submit

March 2, 2017

Conditions

Platelet Function

Keywords

Platelet functionhemofiltrationMultiplate

Outcome Measures

Primary Outcomes (1)

  • ASPItest

    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.

    Baseline, 6, 12, 24 and 48 hours

Secondary Outcomes (4)

  • ADPtest

    Baseline, 6, 12, 24 and 48 hours

  • TRAPtest

    Baseline, 6, 12, 24, 48 hours

  • CT-INTEM

    Baseline, 6, 12, 24 and 48 hours

  • MCF-INTEM

    Baseline, 6, 12, 24 and 48hours

Other Outcomes (8)

  • Age

    Baseline

  • Height

    Baseline

  • Weight

    Baseline

  • +5 more other outcomes

Study Arms (1)

Dialysis

Platelet function will be documented during the first 48 hours of veno-venous hemofiltration using the Multiplate system.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in an intensive care unit with the need for a renal replacement therapy-

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe-University

Frankfurt am Main, Hesse, 60590, Germany

Location

Related Publications (1)

  • Daugirdas JT, Bernardo AA. Hemodialysis effect on platelet count and function and hemodialysis-associated thrombocytopenia. Kidney Int. 2012 Jul;82(2):147-57. doi: 10.1038/ki.2012.130. Epub 2012 May 16.

    PMID: 22592187BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med Saskia Wand

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 23, 2013

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 3, 2017

Record last verified: 2017-03

Locations

DE(1)