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Prostacyclin's Effect on Platelet Responsiveness

Primary Purpose

Acute Kidney Failure

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
prostacyclin
heparin
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Failure focused on measuring Anticoagulation, Prostacyclin, Heparin, Renal Replacement Therapy, Kidney failure acute, Platelet aggregation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Policlinico Gemelli

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 prostacyclin group

2 heparin group

Arm Description

prostacyclin analogue (PGIA) used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients

unfractionated heparin used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 23, 2009
Last Updated
April 28, 2009
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT00890214
Brief Title
Prostacyclin's Effect on Platelet Responsiveness
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 Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Failure
Keywords
Anticoagulation, Prostacyclin, Heparin, Renal Replacement Therapy, Kidney failure acute, Platelet aggregation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 prostacyclin group
Arm Type
Active Comparator
Arm Description
prostacyclin analogue (PGIA) used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
Arm Title
2 heparin group
Arm Type
Active Comparator
Arm Description
unfractionated heparin used as circuit anticoagulant during continuous venovenous hemodiafiltration (CVVHDF) in acute kidney failure patients
Intervention Type
Drug
Intervention Name(s)
prostacyclin
Other Intervention Name(s)
prostacyclin epoprostenol (PGIA) (Flolan®, Glaxo-Wellcome)
Intervention Description
prostacyclin was infused as CRRT circuit anticoagulant into the arterial-line of the circuit at 4 ng/Kg/min
Intervention Type
Drug
Intervention Name(s)
heparin
Other Intervention Name(s)
unfractionated heparin UFH (Liquemin®, Roche).
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Antonelli, MD
Organizational Affiliation
Istituto Anestesia e Rianimazione Università Cattolica Policlinico Gemelli
Official's Role
Study Director
Facility Information:
Facility Name
Policlinico Gemelli
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
33314078
Citation
Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.
Results Reference
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Prostacyclin's Effect on Platelet Responsiveness

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