Clinical Trial Comparing Catheter Lock Solutions TaurolockTMHep 100 and Heparin 100 IE/ml.
Information source: Rigshospitalet, Denmark
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Catheter-related Bloodstream Infection (CRBSI) Nos
Intervention: TaurolockTMHep100 (Device); Heparin 100 IE/ml (Device)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Palle Bekker Jeppesen Official(s) and/or principal investigator(s): Palle B Jeppesen, Ass. Prof., Principal Investigator, Affiliation: Medicinsk Gastroenterologisk klinik CA, 2121, Abdominal centret, Rigshospitalet
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Mean number of catheter related blood stream infections(CRBSI)/ 1000 catheter days in each group
Secondary outcome: Median time to a catheter related blood stream infection(CRBSI) in each group.Number and frequency of catheter removals due to catheter-related infections in each group Number and frequency of exit site infections in each group Median time to catheter removal due to catheter-related infections in each group Number and frequency of catheter occlusions in each group Number and frequency of patients having serious adverse event and adverse event in each group
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Rigshospitalet, abdominalcentret, Medicinsk Gastroenterologisk klinik CA, 2121, Copenhagen 2100, Denmark
Additional Information
Starting date: October 2013
Last updated: June 19, 2014
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