Use of Tinzaparin for Anticoagulation in Hemodialysis | NCT01930396

Studies
Use of Tinzaparin for Anticoagulation in Hemodialysis

NCT01930396

Sponsor

Christine Ribic

Status

Completed

Last Update Posted

Oct 14, 2016Estimated

Enrollment

191Actual

Phase

Phase 4

Conditions

Kidney Failure, Chronic

Interventions

Tinzaparin
Unfractionated Heparin
Placebo (for Tinzaparin)
Placebo (for Unfractionated Heparin)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Sep 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Aug 22, 2013

First Submission Date that Met QC Criteria

Aug 27, 2013

First Posted Date

Aug 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 14, 2016Estimated

Name	Class
McMaster University	OTHER
LEO Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The HEMO-TIN trial is designed to look at both the safety (bleeding risk) and effectiveness (clotting risk) of tinzaparin compared with unfractionated heparin for anticoagulation in hemodialysis patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

191Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tinzaparin	Experimental		Drug: Tinzaparin Drug: Placebo (for Unfractionated Heparin)
Unfractionated Heparin	Active Comparator		Drug: Unfractionated Heparin Drug: Placebo (for Tinzaparin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tinzaparin	Drug		Tinzaparin	Innohep
Unfractionated Heparin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of major, clinically important non-major or minor bleeding		26 weeks

Secondary Outcomes

Measure	Description	Time Frame
Clotting in extracorporeal dialysis circuit		During Hemodialysis (weekly for 26 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years
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:

Therapeutic systemic anticoagulation
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dr. Christine M Ribic, MD, MSc	St. Joseph's Healthcare Hamilton/McMaster University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Healthcare Hamilton		Hamilton	Ontario	L8N 4A6	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38189593	Derived	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.

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates