MedDataX Logo

Prostacyclin's Effect on Platelet Responsiveness

NCT ID: NCT00890214

Last Updated: 2009-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Failure

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Anticoagulation Prostacyclin Heparin Renal Replacement Therapy Kidney failure acute Platelet aggregation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 prostacyclin group

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

Group Type ACTIVE_COMPARATOR

prostacyclin

Intervention Type DRUG

prostacyclin was infused as CRRT circuit anticoagulant into the arterial-line of the circuit at 4 ng/Kg/min

2 heparin group

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

Group Type ACTIVE_COMPARATOR

heparin

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prostacyclin

prostacyclin was infused as CRRT circuit anticoagulant into the arterial-line of the circuit at 4 ng/Kg/min

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

prostacyclin epoprostenol (PGIA) (Flolan®, Glaxo-Wellcome) unfractionated heparin UFH (Liquemin®, Roche).

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Catholic University of the Sacred Heart

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Istituto di Anestesia e Rianimazione

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Massimo Antonelli, MD

Role: STUDY_DIRECTOR

Istituto Anestesia e Rianimazione Università Cattolica Policlinico Gemelli

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Policlinico Gemelli

Rome, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 33314078 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AABR-0609

Identifier Type: -

Identifier Source: org_study_id