NCT00890214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
Last Updated

April 29, 2009

Status Verified

April 1, 2009

Enrollment Period

8 months

First QC Date

April 23, 2009

Last Update Submit

April 28, 2009

Conditions

Keywords

AnticoagulationProstacyclinHeparinRenal Replacement TherapyKidney failure acutePlatelet aggregation

Study Arms (2)

1 prostacyclin group

ACTIVE COMPARATOR

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

Drug: prostacyclin

2 heparin group

ACTIVE COMPARATOR

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

Drug: heparin

Interventions

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

Also known as: prostacyclin epoprostenol (PGIA) (Flolan®, Glaxo-Wellcome)
1 prostacyclin group

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.

Also known as: unfractionated heparin UFH (Liquemin®, Roche).
2 heparin group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • critically patients ill patients with acute kidney failure (AKI) needing renal replacement therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Gemelli

Rome, 00168, Italy

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

EpoprostenolHeparin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins IProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Massimo Antonelli, MD

    Istituto Anestesia e Rianimazione Università Cattolica Policlinico Gemelli

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 29, 2009

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

April 29, 2009

Record last verified: 2009-04

Locations