Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prostacyclin's Effect on Platelet Responsiveness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00890214
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Sponsor:
Information provided by:
Catholic University of the Sacred Heart

Tracking Information
First Submitted Date  ICMJE April 23, 2009
First Posted Date  ICMJE April 29, 2009
Last Update Posted Date April 29, 2009
Study Start Date  ICMJE September 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prostacyclin's Effect on Platelet Responsiveness
Official Title  ICMJE Heparin Versus Prostacyclin in Continuous Hemodiafiltration for Acute Renal Failure: Effects on Platelet Responsiveness in the Systemic Circulation and Across the Filter.
Brief Summary The researchers investigated the influence of a prostacyclin analogue (PGIA) versus unfractionated heparin (UFH) on ex vivo platelet function, during continuous venovenous hemodiafiltration.
Detailed Description Context and purpose of the study: Prospective, randomized comparison of a PGIA versus UFH as circuit anticoagulant. Platelet responsiveness was assessed from peripheral blood by light-transmittance aggregometry (LTA) induced by collagen and ADP, at baseline, 4 and 24 hrs after treatment onset. Platelet function was also assessed in blood samples collected in the circuit before and after the filter. The Setting was a University Hospital Intensive Care Unit. 23 ICU patients with Acute Renal Failure needing CVVHDF were studied during standard CVVHDF therapy, at random infusion in the extracorporeal circuit of PGIA or UFH.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Failure
Intervention  ICMJE
  • Drug: prostacyclin
    prostacyclin was infused as CRRT circuit anticoagulant into the arterial-line of the circuit at 4 ng/Kg/min
    Other Name: prostacyclin epoprostenol (PGIA) (Flolan®, Glaxo-Wellcome)
  • Drug: heparin
    was prepared using our standard protocol: 2 ml of an already-stored solution containing 5000 IU/ml of UFH were diluted in 20 ml of saline obtaining a final concentration of 500 IU/ml, and infused pre-filter at 6 IU/Kg/h, according to the post-filter activated clotting time measured hourly, and adjusted to obtain a value between 180 and 200 sec.
    Other Name: unfractionated heparin UFH (Liquemin®, Roche).
Study Arms  ICMJE
  • Active Comparator: 1 prostacyclin group
    prostacyclin analogue (PGIA) used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
    Intervention: Drug: prostacyclin
  • Active Comparator: 2 heparin group
    unfractionated heparin used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
    Intervention: Drug: heparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April¬†28,¬†2009)
23
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • critically patients ill patients with acute kidney failure (AKI) needing renal replacement therapy

Exclusion Criteria:

  • therapy with aspirin or other non-steroidal anti-inflammatory drugs in the previous 7 days
  • concomitant treatment with other extracorporeal organ-assist devices any other drug affecting coagulation or platelets
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00890214
Other Study ID Numbers  ICMJE AABR-0609
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Massimo Antonelli, Istituto di Anestesia e Rianimazione
Study Sponsor  ICMJE Catholic University of the Sacred Heart
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Massimo Antonelli, MD Istituto Anestesia e Rianimazione Università Cattolica Policlinico Gemelli
PRS Account Catholic University of the Sacred Heart
Verification Date April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP