NCT00260988

Brief Summary

The purpose of this study is to better understand if either dalteparin or tinzaparin is a better drug to use in dialysis patients on blood thinners who are at high risk of developing blood clots and need surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

September 10, 2014

Status Verified

July 1, 2009

Enrollment Period

5.1 years

First QC Date

November 30, 2005

Last Update Submit

September 8, 2014

Conditions

ThromboembolismHemodialysis

Keywords

ProphylaxisThromboembolic diseaseEnd stage renal diseaseHemodialysisPharmacokineticsLow Molecular Weight HeparinInnohepTinzaparinFragminDalteparinAnti XaINROral anticoagulationwarfarinCoumadin

Outcome Measures

Primary Outcomes (1)

  • Primary outcome will be the comparison of the pharmacokinetic profiles of dalteparin and tinzaparin in patients on hemodialysis in the setting of perioperative anticoagulation for thromboembolic prophylaxis. Specifically pre-dialysis anti-Xa levels post

    Anti-Xa levels were drawn pre-dialysis (at a timepoint that was within 20-24hrs post- LMWH dose) and post- dialysis

    Pre-dialysis following the third dose of LMWH

Secondary Outcomes (2)

  • The frequency of surgery cancellation

    Cumulatively collected at end of study

  • Bleeding complications

    Any reported and elicited bleeding event will be captured throughout the study period

Study Arms (2)

Dalteparin

ACTIVE COMPARATOR

Dalteparin 200 IU/kg/day for three days prior to surgery and dalteparin 5000IU daily for 3-5 days post-surgery

Drug: Fragmin (dalteparin)

Tinzaparin

ACTIVE COMPARATOR

Tinzaparin 175 IU/kg/day for three days prior to surgery and Tinzaparin 4500 IU for 3-5 days post surgery

Drug: Innohep (tinzaparin)

Interventions

Fragmin (dalteparin)DRUG

200 IU/Kg/Day administered subcutaneously for three days prior to but not including the day of the surgery

Dalteparin
Innohep (tinzaparin)DRUG

175 IU/kg/Day administered subcutaneously for three days prior to but not including the day of the surgery

Tinzaparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • Patients aged \>= 18 with end stage renal disease requiring chronic hemodialysis (HD) three times a week and clinically stable on HD for 4 weeks (x 4 wks)
  • Patients requiring active oral anticoagulation for prosthetic heart valves, recent deep vein thrombosis \>= 1 month, or patients with atrial fibrillation and a major risk factor (previous transient ischemic attack \[TIA\] or stroke, high blood pressure, diabetes, aged \>= 75, moderate/severe left ventricle dysfunction) who require elective non-cardiac surgery or an invasive procedure with reversal of their anticoagulant therapy.

You may not qualify if:

  • Evidence of active bleeding prior to stopping warfarin
  • Hemoglobin \<= 90 or platelet count \<= 100x10\^9/L
  • Uncontrolled hypertension or stroke within 6 months of study commencement
  • Spinal or neurosurgery
  • Eye surgery (excluding cataract surgery)
  • Life expectancy less than 3 months
  • Patients requiring cardiac surgery
  • Presence of active duodenal ulcer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Joseph's Healthcare

Hamilton, Ontario, L8N4A6, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y4E9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 38189593DERIVED

MeSH Terms

Conditions

ThromboembolismKidney Failure, Chronic

Interventions

DalteparinTinzaparin

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Marc Rodger, MD, MSc

    OHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 2, 2005

Study Start

October 1, 2003

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 10, 2014

Record last verified: 2009-07

Locations

CA(2)