Prostacyclin's Effect on Platelet Responsiveness

This study has been completed.
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00890214
First received: April 23, 2009
Last updated: April 28, 2009
Last verified: April 2009
  Purpose

The researchers investigated the influence of a prostacyclin analogue (PGIA) versus unfractionated heparin (UFH) on ex vivo platelet function, during continuous venovenous hemodiafiltration.


Condition Intervention Phase
Acute Kidney Failure
Drug: prostacyclin
Drug: heparin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Enrollment: 23
Study Start Date: September 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00890214

Locations
Italy
Policlinico Gemelli
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Study Director: Massimo Antonelli, MD Istituto Anestesia e Rianimazione Università Cattolica Policlinico Gemelli
  More Information

No publications provided

Responsible Party: Massimo Antonelli, Istituto di Anestesia e Rianimazione
ClinicalTrials.gov Identifier: NCT00890214     History of Changes
Other Study ID Numbers: AABR-0609
Study First Received: April 23, 2009
Last Updated: April 28, 2009
Health Authority: Italy: National Bioethics Committee
Italy: National Institute of Health

Keywords provided by Catholic University of the Sacred Heart:
Anticoagulation
Prostacyclin
Heparin
Renal Replacement Therapy
Kidney failure acute
Platelet aggregation

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Tezosentan
Epoprostenol
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents
Antihypertensive Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014