Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
191 participants
INTERVENTIONAL
2013-09-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Tinzaparin
Tinzaparin
Placebo (for Unfractionated Heparin)
0.9% Normal Saline
Unfractionated Heparin
Unfractionated Heparin
Placebo (for Tinzaparin)
0.9% Normal Saline
Interventions
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Tinzaparin
Unfractionated Heparin
Placebo (for Tinzaparin)
0.9% Normal Saline
Placebo (for Unfractionated Heparin)
0.9% Normal Saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* End stage renal disease maintained on outpatient hemodialysis for \>= 3 months
* Frequency of hemodialysis: 3 times per week
* Anticoagulation with an unfractionated heparin protocol for at least 4 weeks
* Patient or legal guardian able to provide written consent
* Baseline INR \<= 1.3
* Baseline platelet count \>= 80,000 x 10\^9/L
Exclusion Criteria
* Clinically apparent bleeding in the last 2 months
* High risk of bleeding
* Planned major surgery in the next 4 months
* Major surgery in the past 48 hours
* Pregnant or lactating
* Child bearing potential
* Allergy/intolerance to heparin or history of heparin induced thrombocytopenia
* Current participation in a related randomized drug trial
18 Years
ALL
No
Sponsors
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McMaster University
OTHER
LEO Pharma
INDUSTRY
Christine Ribic
OTHER
Responsible Party
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Christine Ribic
Nephrologist
Principal Investigators
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Dr. Christine M Ribic, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare Hamilton/McMaster University
Locations
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St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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References
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Natale P, Palmer SC, Ruospo M, Longmuir H, Dodds B, Prasad R, Batt TJ, Jose MD, Strippoli GF. Anticoagulation for people receiving long-term haemodialysis. Cochrane Database Syst Rev. 2024 Jan 8;1(1):CD011858. doi: 10.1002/14651858.CD011858.pub2.
Other Identifiers
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13-7822377
Identifier Type: -
Identifier Source: org_study_id
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