Prostacyclin's Effect on Platelet Responsiveness - Full Text View

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:

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin Epoprostenol Epoprostenol sodium

U.S. FDA Resources

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).

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

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:

Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
Anticoagulants
Heparin
Epoprostenol
Tezosentan
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Platelet Aggregation Inhibitors
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 21, 2013