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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. Identifier: NCT00890214
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
Information provided by:
Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Acute Kidney Failure Drug: prostacyclin Drug: heparin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Heparin Versus Prostacyclin in Continuous Hemodiafiltration for Acute Renal Failure: Effects on Platelet Responsiveness in the Systemic Circulation and Across the Filter.
Study Start Date : September 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: 1 prostacyclin group
prostacyclin analogue (PGIA) used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
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)

Active Comparator: 2 heparin group
unfractionated heparin used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
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).

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00890214

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Policlinico Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
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Study Director: Massimo Antonelli, MD Istituto Anestesia e Rianimazione Università Cattolica Policlinico Gemelli
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Massimo Antonelli, Istituto di Anestesia e Rianimazione Identifier: NCT00890214    
Other Study ID Numbers: AABR-0609
First Posted: April 29, 2009    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009
Keywords provided by Catholic University of the Sacred Heart:
Renal Replacement Therapy
Kidney failure acute
Platelet aggregation
Additional relevant MeSH terms:
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Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents