Clinical Trial Comparing Catheter Lock Solutions TaurolockTMHep 100 and Heparin 100 IE/ml.

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TauroPharm
Information provided by (Responsible Party):
Palle Bekker Jeppesen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01948245
First received: September 16, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The purpose of the investigation is to compare two catheter lock solutions (TaurolockTMHep100 and Heparin 100 IE/ml), on the occurence of catheter related blood stream infection, in patients with intestinal failure and a central venous access device for home parenteral nutrition.


Condition Intervention Phase
Catheter-related Bloodstream Infection (CRBSI) Nos
Device: TaurolockTMHep100
Device: Heparin 100 IE/ml
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double Blinded, Randomized, Controlled Investigation of Taurolidine-citrate/Heparin Catheter Lock Solution Versus Heparin in Patients on Home Parenteral Nutrition With Previously Proven High Risk of Catheter Related Blood Stream Infections.

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median time to a catheter related blood stream infection(CRBSI) in each group. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number and frequency of catheter removals due to catheter-related infections in each group [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number and frequency of exit site infections in each group [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Median time to catheter removal due to catheter-related infections in each group [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number and frequency of catheter occlusions in each group [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Number and frequency of patients having serious adverse event and adverse event in each group [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Patient satisfaction with the assigned catheter lock solution in each group [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    1= not at all satisfied, 2= unsatisfied, 3= satisfied, 4= very satisfied

  • Costs of catheter lock solution plus cost of hospitalization, unscheduled outpatient-clinic consultations, drug treatment costs of infections and catheter changes [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: October 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TaurolockTMHep100

2-4 ml of TaurolockTMHep100 will be instilled into the central venous access device (CVAD)after each infusion of parenteral nutrition/intravenous fluids. The instillation varying between twice per week to once daily depending on the patients individual HPN programme. The catheter lock solution is kept in situ in the lumen to the next infusion.

The duration of TaurolockTMHep100 administration will be maximum 24 month or until occurence of primary outcome(CRBSI).

Device: TaurolockTMHep100
2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids.
Other Name: Taurolidine 1,35%/citrate 4 %/heparin 100 IE/ml
Placebo Comparator: Heparin 100 IE/ml

2-4 ml of Heparin 100 IE/mk will be instilled into the central venous access device (CVAD)after each infusion of parenteral nutrition/intravenous fluids. The instillation varying between twice per week to once daily depending on the patients individual HPN programme. The catheter lock solution is kept in situ in the lumen to the next infusion.

The duration of Heparin 100 IE/ml administration will be maximum 24 month or until occurence of primary outcome(CRBSI).

Device: Heparin 100 IE/ml
2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids.

Detailed Description:

Patients with long-term intestinal failure are dependent on Home Parenteral Nutrition(HPN) delivered through a central venous access device(CVAD), placed as a subcutaneous tunneled catheter(Broviac). Catheter Related Blood Stream Infections(CRBSI) is a frequent complication leading to increased morbidity, hospital admissions, cost, and risk of repeated replacement of their tunneled catheter. The infections often originate from contamination of the catheter hub, and growth of microorganisms on the inner lumen of the catheter imbedded in a biofilm. To prevent infections good hygiene guidelines and the use of a catheter lock solution is applied.

The primary objective is to compare two catheter lock solutions, TaurolockTMHep100 and Heparin 100 IE/ml, on the occurence of CRBSI. The secondary objectives are to compare the two devices according to other efficacy parameters, time to infection, cost and resource utility, tolerability and safety.

Patients with a prior high risk of CRBSI will be included. Patients will instill the solution in their CVAD after each infusion of HPN, varying between minimum twice per week to once daily, depending on their individual HPN programme.

Before the blinded randomization the patients will be paired according to gender, age and prior infection risk.

Duration of the instillation will be 24 month or until outcome(CRBSI) accure.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with long-term intestinal failure who will receive PS at least 2 times /week over a subcutaneously tunneled single-lumen CVC (Hickman/Broviac) for at least one year.
  • Estimated life expectancy ≥1 year
  • Male or female patient aged 18 - 80 years
  • Patient is fully able to understand the nature of the proposed intervention and gives written informed consent before entering the trial.

Exclusion Criteria:

Patients who:

  • can not be expected to comply with the trial plan (e.g. substance abuse, mental condition)
  • has significant cardiovascular disease such as unstable angina, recent acute myocardial infarction or recent cerebral vascular accident (within 6 weeks); a cardiac rhythm which in the investigators judgment may result in significant hemodynamic effects
  • has a known hypersensitivity/allergy to TauroLockTMHep 100 or heparin and/or their excipients.
  • is pregnant, lactating, or nursing
  • has abnormal blood coagulation due to primary disease or due to treatment with anticoagulants (warfarin/phenprocoumon, unfractionated heparin, low- molecular heparin), with the clinical blood tests INR and APTT, outside the intervals given below, at the time of inclusion. Patients with unfractionated Heparin 100 IE/ml used as a catheter lock, do not need to have APTT tested before enrollment. Patients treated with Low-Molecular Heparin, needs control of INR, thrombocytes and plasma-antifactor Xa, and If the patient has increased bleeding risk judge by disease and clinical blood tests, the patient can´t be included in the trial. INR 0.9-3.0 (warfarin/ phenprocoumon) APTT needs to be in the range 25-100 seconds (Unfractionated Heparin treatment) Plasma-antifactor Xa( outside recommended intervals (pro.medicin.dk), which are dependent on administration form and number of daily administrations ). Thrombocytes 100- 600 x109/L
  • Patients with a new catheter-related thrombosis in the last 3 months prior to inclusion.
  • has received an investigational drug within 30 days of trial entry
  • has received a TauroLockTMHep 100 solution previously
  • has an antibiotic coated, silver impregnated or antimicrobial cuff catheter
  • has compromised skin integrity, including any infection at the insertion site
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01948245

Locations
Denmark
Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Palle Bekker Jeppesen
TauroPharm
Investigators
Principal Investigator: Palle B Jeppesen, Ass. Prof. Medicinsk Gastroenterologisk klinik CA, 2121, Abdominal centret, Rigshospitalet
  More Information

No publications provided

Responsible Party: Palle Bekker Jeppesen, assistent professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01948245     History of Changes
Other Study ID Numbers: H-4-2013-127, 38202
Study First Received: September 16, 2013
Last Updated: June 19, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:
Catheter Related Blood Stream Infection
Long-term intestinal Failure
Taurolidine
Catheter lock solution
Antimicrobial agent
Home Parenteral Nutrition
Anti-infective agents

Additional relevant MeSH terms:
Taurolidine
Anti-Infective Agents
Calcium heparin
Heparin
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Infective Agents, Local
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 28, 2014