Monitoring Platelet Function During Continuous Hemodialysis

Platelet Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837758
• Other study ID #: CVVH-Multiplate
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: March 2, 2017
• Start date: December 2012
• Est. completion date: August 2013

Study information

• Verified date: March 2017
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Platelet Function

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe-University	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age	Age of the patient at the point of enrollment	Baseline
Other	Height	Height of the patient measured in centimeters.	Baseline
Other	Weight	Weight of the patient measured in kilograms.	Baseline
Other	Gender		Baseline
Other	ASA-Classification	The ASA-Classification will be determined preoperatively.	Baseline
Other	Antiaggregatory Premedication	Antiaggregatory medication taken prior to enrollment wil be recorded in the categories aspirin, clopidogrel, ticagrelor, cumarins and others.	Baseline
Other	Dialysis filter	The brand of filter used for the hemofiltration or hemodialysis will be registered.	Basline
Other	Anticoagulation for hemofiltration	The anticoagulation used for hemofiltration will be recorded in the categories heparin and calcium citrate.	Baseline
Primary	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	ADPtest	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.	Baseline, 6, 12, 24 and 48 hours
Secondary	TRAPtest	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.	Baseline, 6, 12, 24, 48 hours
Secondary	CT-INTEM	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.	Baseline, 6, 12, 24 and 48 hours
Secondary	MCF-INTEM	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.	Baseline, 6, 12, 24 and 48hours