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Soroka S, Agharazii M, Donnelly S, et al. 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;5:2054358118809104doi: 10.1177/2054358118809104.
Soroka, S., Agharazii, M., Donnelly, S., Roy, L., Muirhead, N., Cournoyer, S., MacKinnon, M., Pannu, N., Barrett, B., Madore, F., Tennankore, K., Wilson, J. A., Hilton, F., Sherman, N., Wolter, K., Orazem, J., & Feugère, G. (2018). 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). Canadian journal of kidney health and disease, 52054358118809104. https://doi.org/10.1177/2054358118809104
Soroka, Steven, et al. "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)." Canadian journal of kidney health and disease vol. 5 (2018): 2054358118809104. doi: https://doi.org/10.1177/2054358118809104
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, Feugère 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 04;5:2054358118809104. doi: 10.1177/2054358118809104. eCollection 2018. PMID: 30542622; PMCID: PMC6236648.
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Can J Kidney Health Dis. 2018 Nov 04;5:2054358118809104. doi: 10.1177/2054358118809104. eCollection 2018.

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).

Canadian journal of kidney health and disease

Steven Soroka, Mohsen Agharazii, Sandra Donnelly, Louise Roy, Norman Muirhead, Serge Cournoyer, Martin MacKinnon, Neesh Pannu, Brendan Barrett, François Madore, Karthik Tennankore, Jo-Anne Wilson, Fiona Hilton, Nancy Sherman, Kevin Wolter, John Orazem, Guillaume Feugère

Affiliations

  1. Division of Nephrology, Dalhousie University, Halifax, NS, Canada.
  2. Endocrinology and Nephrology, CHU de Québec Research Center, L'Hôtel-Dieu de Québec, Université Laval, Québec City, QC, Canada.
  3. Division of Nephrology, William Osler Health System, Brampton Civic Hospital, Brampton, ON, Canada.
  4. Department of Medicine, Centre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.
  5. Department of Medicine, London Health Sciences Centre, Western University, London, ON, Canada.
  6. Nephrology, Hôpital Charles-LeMoyne, Greenfield Park, QC, Canada.
  7. Division of Nephrology, Horizon Health, Saint John, NB, Canada.
  8. Nephrology, University of Alberta, Edmonton, AB, Canada.
  9. Division of Nephrology, Memorial University of Newfoundland, St. John's, Newfoundland and Labrador, Canada.
  10. Faculté de Médecine, Hôpital du Sacré-Cœur de Montréal, Montréal, QC, Canada.
  11. Pfizer Essential Health, Pfizer Inc, Groton, CT, USA.
  12. Pfizer Essential Health, Pfizer Inc, New York, NY, USA.
  13. Pfizer Essential Health, Pfizer Canada Inc, Kirkland, QC, Canada.

PMID: 30542622 PMCID: PMC6236648 DOI: 10.1177/2054358118809104

Abstract

BACKGROUND: Dalteparin sodium, a low-molecular-weight heparin, is indicated for prevention of clotting in the extracorporeal circuit during hemodialysis (HD). Product labeling recommends a fixed single-bolus dose of 5000 international units (IU) for HD sessions lasting up to 4 hours, but adjustable dosing may be beneficial in clinical practice.

OBJECTIVE: The aim of the PARROT study was to investigate the safety and efficacy of an adjustable dose of dalteparin in patients with end-stage renal disease requiring 3 to 4 HD sessions per week.

DESIGN: A 7-week, open-label, multicenter study with a single treatment arm, conducted between October 2013 and March 2016.

SETTING: Ten sites in Canada.

PATIENTS: A total of 152 patients with end-stage renal disease requiring 3 to 4 HD sessions per week.

MEASUREMENTS: The primary outcome was the proportion of HD sessions completed without premature termination due to inadequate anticoagulation.

METHODS: All participants initially received a dose of 5000 IU dalteparin, which could be adjusted at subsequent HD sessions when clinically indicated, by increment or decrement of 500 or 1000 IU, with no specified dose limits.

RESULTS: Patients were followed for 256 patient-months. Nearly all (99.9%; 95% confidence interval [CI]: 99.7-100) evaluable HD sessions were completed without premature clotting. Dose was adjusted for more than half (52.3%) of participants, mostly owing to clotting or access compression time >10 minutes. Median dalteparin dose was 5000 IU (range: 500-13 000 IU). There were no major bleeds, and minor bleeding was reported in 2.3% of all HD sessions. There was no evidence of bioaccumulation.

LIMITATIONS: This short-term study, with a single treatment arm, was designed to optimize dalteparin dose using a flexible dosing schedule; it was not designed to specifically evaluate dalteparin dose minimization, provide a direct comparison of dalteparin versus unfractionated heparin, or provide information on long-term safety for flexible dalteparin dosing. Patients were excluded if they were at high risk of bleeding, including those on anticoagulants and those on antiplatelet agents other than aspirin <100 mg/d.

CONCLUSIONS: Overall, an adjustable dalteparin sodium dose regimen allowed safe completion of HD, with clinical benefits over fixed dosing.

TRIAL REGISTRATION: ClinicalTrials.gov NCT01879618, registered June 13, 2013.

Keywords: adjustable dose; clinical study; dalteparin sodium; end-stage renal disease; hemodialysis

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: SS, MA, SD, LR,

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