Prostacyclin's Effect on Platelet Responsiveness
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| ClinicalTrials.gov Identifier: NCT00890214 |
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Recruitment Status :
Completed
First Posted : April 29, 2009
Last Update Posted : April 29, 2009
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Sponsor:
Catholic University of the Sacred Heart
Information provided by:
Catholic University of the Sacred Heart
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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 |
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 : | 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 |
|---|---|
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Active Comparator: 1 prostacyclin group
prostacyclin analogue (PGIA) used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
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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) |
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Active Comparator: 2 heparin group
unfractionated heparin used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
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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 |
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
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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 ClinicalTrials.gov identifier (NCT number): 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Massimo Antonelli, Istituto di Anestesia e Rianimazione |
| ClinicalTrials.gov 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:
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Anticoagulation Prostacyclin Heparin |
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 Epoprostenol Heparin Calcium heparin Tezosentan |
Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Platelet Aggregation Inhibitors Vasodilator Agents |