NCT00756145

Brief Summary

Low molecular weight heparin (LMWH) is injected in the dialysis circuit at the start of the session. In the present study we compare 3 different methods of injection of LMWH: parameters of dialysis efficiency and clotting are measured. The study lasts 3 sessions for each patient.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

September 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 19, 2008

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 14, 2015

Status Verified

May 1, 2015

Enrollment Period

6.7 years

First QC Date

September 18, 2008

Last Update Submit

May 13, 2015

Conditions

Chronic Kidney Disease

Keywords

stage Vtreatedhemodiafiltration

Outcome Measures

Primary Outcomes (1)

  • Anti-Xa activity at the end of the session

    240 min after start

Secondary Outcomes (6)

  • Anti-Xa activity during the session

    at start, 30 min, 120 min and 180 min

  • ETP during the session

    at start, 30 min, 120 min, 180 min and 240 min

  • Reduction ratio of urea

    after 10min, 180min and 240min

  • Reduction ratio of beta2microglobulin

    after 10min, 180min and 240min

  • Visual inspection of membrane and circuit

    After the hemodiafiltration session

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

Injection of LMWH at the start of the hemodiafiltration session, at the inlet bloodline

Procedure: At start of the session, at the inlet line

2

EXPERIMENTAL

Injection of LMWH 5 minutes after the start of the hemodiafiltration session, at the inlet bloodline

Procedure: 5 minutes after the start of the session, at the inlet line

3

EXPERIMENTAL

Injection of LMWH at the start of the hemodiafiltration session, at the outline bloodline

Procedure: At the start of the session, at the outlet line

Interventions

At start of the session, at the inlet linePROCEDURE

Injection of LMWH at the inlet line, at the start of the hemodiafiltration session

1
5 minutes after the start of the session, at the inlet linePROCEDURE

Injection of LMWH at the inlet line, 5 minutes after the start of the hemodiafiltration session

2
At the start of the session, at the outlet linePROCEDURE

Injection of LMWH at the outlet line, at the start of the hemodiafiltration session

3

Eligibility Criteria

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

You may qualify if:

  • chronic kidney disease stade V treated with hemodiafiltration
  • age \>18 year
  • Hematocrit \> 30%

You may not qualify if:

  • treatment with vitamin K antagonists
  • treatment with other anti-coagulants or heparin besides the heparin used during dialysis
  • active bleeding, infection or malignancy
  • heparin associated allergy
  • hepatic failure
  • trombocytopenia \< 120.000/µl

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (2)

  • 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

  • Dhondt A, Pauwels R, Devreese K, Eloot S, Glorieux G, Vanholder R. Where and When To Inject Low Molecular Weight Heparin in Hemodiafiltration? A Cross Over Randomised Trial. PLoS One. 2015 Jun 15;10(6):e0128634. doi: 10.1371/journal.pone.0128634. eCollection 2015.

    PMID: 26076014DERIVED

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annemieke Dhondt, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 19, 2008

Study Start

September 1, 2008

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 14, 2015

Record last verified: 2015-05

Locations

BE(1)