ArticleCanadian journal of kidney health and disease2018
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).
Article in Canadian journal of kidney health and disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01879618 (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), which is not on this map. Cited by 3 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
3 citing papers in PubMed, 5 citations in OpenAlex.
- Efficacy of enoxaparin in preventing coagulation during high-flux haemodialysis, expanded haemodialysis and haemodiafiltration.Clinical kidney journal · 2021Article
- Anticoagulation in CKD and ESRD.Journal of nephrology · 2019Review
- Heparin Drug Shortage Conservation Strategies.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2019Article
Corrections and comments
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Authors and funding
17 authors at 12 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDalteparin 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.
objectiveThe 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.
designA 7-week, open-label, multicenter study with a single treatment arm, conducted between October 2013 and March 2016.
settingTen 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.
methodsAll 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.
resultsPatients 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.
conclusionsOverall, an adjustable dalteparin sodium dose regimen allowed safe completion of HD, with clinical benefits over fixed dosing.
trial registrationClinicalTrials.gov NCT01879618, registered June 13, 2013.
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