NCT01670474

Brief Summary

Surface thrombogenicity of standard double lumen catheters (stDLC) and surface modified film-coated domain structured double lumen catheters (fcDLC) consisting of a novel reactive polyurethane copolymer coating showed that in vitro measured surface thrombogenicity was reduced in the modified catheter compared with standard catheter. The clinical investigation revealed that both number of days before catheter removal according to clinical requirements and number of treatments per catheter were significantly higher with the modified catheter as compared with the standard catheter. Recombinant tissue plasminogen activator (rt-PA) has been used primarily to treat catheter thrombosis. The relatively high cost of rt-PA and its theoretical potential to cause bleeding, as well as the morbidity and mortality associated with catheter malfunction and infection, justify the need for more definitive evidence of the efficacy of rt-PA as a locking solution. No study aims to evaluate the impact of rt-PA locking in long-term Hemodialysis (HD) uncuffed catheters survival.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

1.8 years

First QC Date

March 20, 2012

Last Update Submit

August 20, 2012

Conditions

Malfunction; CatheterThrombosisMechanical Complication of Hemodialysis Catheter

Keywords

Temporary hemodialysis cathetersNon-cuffed hemodialysis cathetersThrombolysisrt-PAThrombosisLifespanBlood flow rateCatheter related bacteriemia

Outcome Measures

Primary Outcomes (1)

  • Lifespan patency with the ability to complete HD session in three different UCs using rt-PA locking protocol

    The ability to achieve blood flow rates of \>= 250 mL/min in three different UCs using rt-PA locking protocol if the UCs present a clotting event (complete or partial thrombosis).

    240 days after patients' enrollement

Secondary Outcomes (2)

  • The incidence of catheter-related bacteremia after rt-PA use in case of thrombosed UCs

    240 days after patients' enrollement

  • Economic evaluation of rt-PA in catheter patency after UCs dysfunction

    240 days after patients' enrollement

Other Outcomes (1)

  • Number of patients who complete HD session with short term HD catheters using rt-PA.

    240 days after patients' enrollement

Study Arms (3)

fmDLC and rt-PA (2mg/2mL actilysis)

EXPERIMENTAL

Surface thrombogenicity of film-coated domain structured double lumen catheters (fmDLC) consisting of a novel reactive polyurethane copolymer coating will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes. Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min.

Drug: rt-PA (2mg/2mL) actilysisDrug: rt-PA

polyDLC and rt-PA (2mg/2mL actilysis)

ACTIVE COMPARATOR

The same procedure will be assessed in the polyurethane double lumen catheter (polyDLC)as with the fmDLC. Indeed, surface thrombogenicity of polyDLC will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes. Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min.

Drug: rt-PA (2mg/2mL) actilysisDrug: rt-PA

siDLC and rt-PA (2mg/2mL actilysis)

ACTIVE COMPARATOR

Same procedure as the previous catheters. Surface thrombogenicity of silicone double lumen catheter (siDLC) will be assessed by measurement of thrombin-antithrombin (TAT) III complex in vitro after the use of rt-PA (2mg/2mL) in each lumen of the catheter for 45 minutes. Each lumen of the thrombosed (dysfunctional) catheter will be locked with the exact volume (luminal volume) of rt-PA (rt-PA (2mg/2mL) actilysis) during 45 min.

Drug: rt-PA (2mg/2mL) actilysisDrug: rt-PA

Interventions

rt-PA (2mg/2mL) actilysisDRUG

At the first catheter dysfunction (Qb \< 250 ml/min) due to thrombotic event, the patient will receive rt-PA (2mg/2mL Alteplase vial - Cathflo, Boehringer Ingelheim, Ingelheim, Germany). Each lumen of the thrombosed catheter is locked with the exact volume (luminal volume) of rt-PA during 45 min. All catheters analyzed (fmDLC, polyDLC and siDLC) will be locked with the exact volume (luminal volume) of rt-PA during 45 min. Each catheter analyzed will be filled with rt-PA (2mg/2mL) if they are dysfunctional as described above in Arm/Group Descriptions: i.e. fmDLC, polyDLC amd siDLC.

Also known as: Cathflo, 2mg/2mL (Boehringer Ingelheim, Ingelheim/Germany
fmDLC and rt-PA (2mg/2mL actilysis)polyDLC and rt-PA (2mg/2mL actilysis)siDLC and rt-PA (2mg/2mL actilysis)
rt-PADRUG

At the first catheter dysfunction (Qb \< 250 ml/min) due to thrombotic event, the patient will receive rt-PA (2mg/2mL Alteplase vial - Cathflo, Boehringer Ingelheim, Ingelheim, Germany). Each lumen of the thrombosed catheter is locked with the exact volume (luminal volume) of rt-PA during 45 min. Each catheter analyzed in this study (i.e. fmDLC, polyDLC, siDLC) will be filled with rt-PA (2mg/2mL) if they are dysfunctional as described above in Arm/Group Descriptions.

Also known as: Cathflo, 2mg/2mL (Boehringer Ingelheim, Ingelheim/Germany)
fmDLC and rt-PA (2mg/2mL actilysis)polyDLC and rt-PA (2mg/2mL actilysis)siDLC and rt-PA (2mg/2mL actilysis)

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • End-stage kidney disease patients with newly inserted temporary untunnelled dual-lumen catheter
  • Naive to study but not naive to catheters (both virgin and non-virgin catheters will be included)
  • Expected to use catheter, and to dialyze at study centre, for at least six months
  • Frequency of HD 3 times per week
  • If indication for catheter was replacement for catheter related infection patients will be eligible after the infection has been treated and the patient has been off antibiotics for 3 HD sessions
  • Patient or legal representative able to provide written consent
  • Eighteen years of age or older
  • Baseline INR ≤ 1.3 (no anticoagulation allowed outside the HD session)
  • Baseline platelet count ≥ 60 x 109/L

You may not qualify if:

  • Use of systemic anticoagulation (if indication for anticoagulation is catheter patency patients may be eligible if the systemic anticoagulation is discontinued and baseline INR is ≤ 1.3)
  • Insertion of a new catheter into the femoral vein
  • Major haemorrhage in the prior 4 weeks, defined as bleeding resulting in a drop in haemoglobin of greater than 20 g/L or bleeding requiring transfusion of packed red blood cells with other clinical evidence or suspicion of bleeding
  • History of intra-cranial bleed in the prior 4 weeks
  • Intra-cranial or intra-spinal neoplasm (current)
  • Allergy or intolerance to rt-PA or heparin or its constituents
  • Active pericarditis - defined by the presence of a pericardial rub
  • Weight ≤ 30 kg or \> 130 kg
  • Patient pregnant or lactating
  • Child bearing potential (i.e. pre-menopausal woman who is not using a reliable method of contraception)
  • Major surgery in past 48 hours (CABG, organ biopsy, puncture of non-compressible vessels), or scheduled for major surgery during the study period
  • Involvement in another randomized drug trial
  • Presence of a fever as defined by a temperature \> 38.2°C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier du Centre du Valais (CHCVs)

Sion, Valais, 1950, Switzerland

RECRUITING

Related Publications (1)

  • Meier P, Meier R, Turini P, Friolet R, Blanc E. Prolonged catheter survival in patients with acute kidney injury on continuous renal replacement therapy using a less thrombogenic micropatterned polymer modification. Nephrol Dial Transplant. 2011 Feb;26(2):628-35. doi: 10.1093/ndt/gfq449. Epub 2010 Jul 28.

    PMID: 20667989RESULT

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Pascal Meier, MD

    CHCVs - RSV - Hôpital du Valais

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Meier, MD

CONTACT

+41276038647pascal.meier@hopitalvs.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2012

First Posted

August 22, 2012

Study Start

January 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

CH(1)