Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA - Clinical Trial for Malfunction; Catheter | NCT01670474

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

rt-PA (2mg/2mL) actilysis

rt-PA

About this trial

This is an interventional treatment trial for Malfunction; Catheter focused on measuring Temporary hemodialysis catheters, Non-cuffed hemodialysis catheters, Thrombolysis, rt-PA, Thrombosis, Lifespan, Blood flow rate, Catheter related bacteriemia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Current use of antibiotics for catheter-related bacteraemia (see inclusion criteria above)
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

Sites / Locations

Centre Hospitalier du Centre du Valais (CHCVs)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

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

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

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

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

The solution instilled into the central venous catheter lumens after each HD session and left in the catheter until the next session (catheter locking solution) is used to prevent thrombosis during the period between HD sessions and may also prevent catheter-related infection.

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

An economic evaluation of rt-PA in catheter patency after dysfunction (partial or complete catheter thrombosis) will be conducted.

Full Information

NCT ID

NCT01670474

First Posted

March 20, 2012

Last Updated

August 20, 2012

Sponsor

Centre Hospitalier du Centre du Valais

1. Study Identification

Unique Protocol Identification Number

NCT01670474

Brief Title

Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA

Acronym

PROCOPrt-PA

Official Title

Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA - PROCOPrt-PA Trial

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

November 2012 (Anticipated)

Study Completion Date

November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier du Centre du Valais

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The solution instilled into the central venous catheter lumens after each HD session and left in the catheter until the next session (catheter locking solution) is used to prevent thrombosis during the period between HD sessions and may also prevent catheter-related infection. However, evidence supporting the use of various locking solutions to achieve these objectives is limited. Heparin has been the traditional locking solution. Several small studies have assessed whether citrate and heparin are equally efficacious for maintaining catheter patency but the interpretation of the results was limited because the studies had a short follow-up period and included both uncuffed and cuffed central venous catheters. Thrombosis is a major cause of HD catheter dysfunction, and this problem is rectified by the use of thrombolytic agents, invasive procedures for declotting, or catheter replacement. A thrombus at the tip of the catheter or a fibrin sheath around it may resist local thrombolysis if it is not reached by sufficient concentrations of the drug. Urokinase has traditionally been used as the thrombolytic agent for HD vascular access declotting, and success rates for declotting vary from 55% to 85%. However, successful treatment of occluded central venous catheter (non HD) with recombinant tissue plasminogen activator (rt-PA) or alteplase was recently achieved in more than 1,000 patients with success (function restored in 798 patients [75.0%; 95% CI: 72.3 to 77.6%]). Serious adverse events monitored within 30 days was very rare and efficacy was independent of age, sex, body weight, and catheter type.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malfunction; Catheter, Thrombosis, Mechanical Complication of Hemodialysis Catheter

Keywords

Temporary hemodialysis catheters, Non-cuffed hemodialysis catheters, Thrombolysis, rt-PA, Thrombosis, Lifespan, Blood flow rate, Catheter related bacteriemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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.

Arm Title

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

Arm Type

Active Comparator

Arm Description

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.

Arm Title

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

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

rt-PA (2mg/2mL) actilysis

Other Intervention Name(s)

Cathflo, 2mg/2mL (Boehringer Ingelheim, Ingelheim/Germany

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

rt-PA

Other Intervention Name(s)

Cathflo, 2mg/2mL (Boehringer Ingelheim, Ingelheim/Germany)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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).

Time Frame

240 days after patients' enrollement

Secondary Outcome Measure Information:

Title

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

Description

The solution instilled into the central venous catheter lumens after each HD session and left in the catheter until the next session (catheter locking solution) is used to prevent thrombosis during the period between HD sessions and may also prevent catheter-related infection.

Time Frame

240 days after patients' enrollement

Title

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

Description

An economic evaluation of rt-PA in catheter patency after dysfunction (partial or complete catheter thrombosis) will be conducted.

Time Frame

240 days after patients' enrollement

Other Pre-specified Outcome Measures:

Title

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

Description

This analysis aims to see if rt-PA will decrease the incidence of catheter malfunction due to thrombosis in three different UCs of different synthetic material.

Time Frame

240 days after patients' enrollement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Current use of antibiotics for catheter-related bacteraemia (see inclusion criteria above) 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pascal Meier, MD

Phone

+41276038647

Email

pascal.meier@hopitalvs.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascal Meier, MD

Organizational Affiliation

CHCVs - RSV - Hôpital du Valais

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier du Centre du Valais (CHCVs)

City

Sion

State/Province

Valais

ZIP/Postal Code

1950

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal Meier, MD

Phone

+41276038647

Email

pascal.meier@hopitalvs.ch

First Name & Middle Initial & Last Name & Degree

Rachel Meier, SN

12. IPD Sharing Statement

Citations:

PubMed Identifier

20667989

Citation

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.

Results Reference

result

Prolonged Hemodialysis Catheter Survival With Copolymer Coating and Rt-PA (PROCOPrt-PA)

Malfunction; Catheter, Thrombosis, Mechanical Complication of Hemodialysis Catheter

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial