Use Of Fragmin In Hemodialysis
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
1 other identifier
interventional
152
1 country
19
Brief Summary
The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2013
19 active sites
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
First Submitted
Initial submission to the registry
June 13, 2013
CompletedFirst Posted
Study publicly available on registry
June 18, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
December 29, 2016
CompletedMarch 10, 2017
January 1, 2017
2.4 years
June 13, 2013
November 2, 2016
January 30, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Percent of Successful HD Sessions
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.
20 HD sessions (up to 4 hours)
Secondary Outcomes (1)
Mean Percent of HD Sessions With an Acceptable Dose
20 HD sessions (up to 4 hours)
Study Arms (1)
Fragmin
EXPERIMENTALFragmin given according to the flexible dosing regimen outlined in the protocol
Interventions
Eligibility Criteria
You may qualify if:
- chronic renal failure on hemodialysis
You may not qualify if:
- significant comorbidities that would prevent a patient from completing the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (19)
Royal Alexandra Hospital
Edmonton, Alberta, T5G 0B8, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8, Canada
Horizon Health Network/Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Eastern Regional Health Authority, Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Eastern Regional Health Authority, St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Eastern Regional Health Authority, Waterford Hospital
St. John's, Newfoundland and Labrador, A1E 4J8, Canada
Queen Elizabeth II Health Sciences Center (QEII) - VG Site
Halifax, Nova Scotia, B3H 2Y9, Canada
William Osler Health System - Bramptom Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
London Health Sciences Centre, University Hospital
London, Ontario, N6A 5A5, Canada
London Health Sciences Centre, Kidney Care Centre
London, Ontario, N6K 1M6, Canada
William Osler Health System
Orangeville, Ontario, L9W 4X9, Canada
Centre intégré de santé et de services sociaux de la Montérégie-Centre
Greenfield Park, Quebec, J4V 2H1, Canada
Centre externe de néphrologie CISSS de la Montérégie-Centre
Greenfield Park, Quebec, J4V 3M3, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc
Montreal, Quebec, H2X 3J4, Canada
CIUSSS du Nord-de-l'Ile-de-Montreal
Montreal, Quebec, H3M 3E3, Canada
CIUSSS du Nord-de-l'Ile-de-Montreal
Montreal, Quebec, H4J 1C5, Canada
CHU de Quebec (Pavillon Hotel-Dieu de Quebec)
Québec, Quebec, G1R 2J6, Canada
Centre externe de néphrologie CISSS de la Montérégie-Centre
Saint-Lambert, Quebec, J4R 2L1, Canada
Related Publications (1)
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.
PMID: 30542622DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2013
First Posted
June 18, 2013
Study Start
October 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
March 10, 2017
Results First Posted
December 29, 2016
Record last verified: 2017-01