Clinical trial NCT01879618: Use Of Fragmin In Hemodialysis
Official title: A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Renal Failure
Keywords: Fragmin
dalteparin
hemodialysis
anticoagulation
Renal Failure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-06-18
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.


Eligibility criteria: Inclusion Criteria:

* chronic renal failure on hemodialysis

Exclusion Criteria:

* significant comorbidities that would prevent a patient from completing the trial

Primary outcomes:
measure: Mean Percent of Successful HD Sessions
timeFrame: 20 HD sessions (up to 4 hours)
Secondary outcomes:
measure: Mean Percent of HD Sessions With an Acceptable Dose
timeFrame: 20 HD sessions (up to 4 hours)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Saint John
country: Canada
facility: Horizon Health Network/Saint John Regional Hospital
state: New Brunswick
city: St. John's
country: Canada
facility: Eastern Regional Health Authority, Health Sciences Centre
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Eastern Regional Health Authority, St. Clare's Mercy Hospital
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Eastern Regional Health Authority, Waterford Hospital
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Center (QEII) - VG Site
state: Nova Scotia
city: Brampton
country: Canada
facility: William Osler Health System - Bramptom Civic Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, Kidney Care Centre
state: Ontario
city: Orangeville
country: Canada
facility: William Osler Health System
state: Ontario
city: Greenfield Park
country: Canada
facility: Centre intégré de santé et de services sociaux de la Montérégie-Centre
state: Quebec
city: Greenfield Park
country: Canada
facility: Centre externe de néphrologie CISSS de la Montérégie-Centre
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS du Nord-de-l'Ile-de-Montreal
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS du Nord-de-l'Ile-de-Montreal
state: Quebec
city: Saint-Lambert
country: Canada
facility: Centre externe de néphrologie CISSS de la Montérégie-Centre
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec (Pavillon Hotel-Dieu de Quebec)
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Soroka S, Agharazii M, Donnelly S, Roy L, Muirhead N, Cournoyer S, MacKinnon M, Pannu N, Barrett B, Madore F, Tennankore K, Wilson JA, Hilton F, Sherman N, Wolter K, Orazem J, Feugere G. An Adjustable Dalteparin Sodium Dose Regimen for the Prevention of Clotting in the Extracorporeal Circuit in Hemodialysis: A Clinical Trial of Safety and Efficacy (the PARROT Study). Can J Kidney Health Dis. 2018 Nov 4;5:2054358118809104. doi: 10.1177/2054358118809104. eCollection 2018.