InfectionPhase 3NCT00207779
Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease
A Phase 3 study testing heparin impregnated central venous catheters in people with Infection, run by Centre National de Greffe de Moelle Osseuse at 1 site in Tunisia.
Trial summary
We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease. Read more about this study
- Who is it for?
- Ages 4 to 60 years
- Conditions the study is for
- Infection
- What is being tested?
- heparin impregnated central venous catheters
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteTunisia
- Study dates
- May 2005to Aug 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 4 and 60 years
- Short term non-tunneled percutaneous central venous catheter
Who cannot join
- Presence of a central venous catheter at admission
- Major blood coagulation disorders (platelet count < 50 x 10^9, disseminated intravascular coagulation)
- Absence of catheter-tip culture at the time of catheter removal
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Centre National de Greffe de Moelle Osseuse
Tunis, Tunis Governorate, 1006
About this study
We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease.
The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:
- Group A: heparin impregnated catheters
- Group B: low-dose unfractionated heparin (100 IU/kg/daily)
Read the detailed description
Studies have shown that catheter-related infection may be due to fibrin deposition associated with catheters. Interventions designed to decrease fibrin deposition and thrombus formation have the potential to reduce catheter-related infections. Seven randomised studies have been performed to assess the safety and efficacy of heparin (either as an infusion or bonded to central venous catheter) on central venous catheter-related bloodstream infections. Although a meta-analysis of 4 studies looking at heparin either as an infusion or bonded to central venous catheter showed a strong trend for a reduction in catheter-related bloodstream infection with the use of heparin, these studies used variable definitions of catheter-related infections.
We have shown in a randomised study (in press), that low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease. The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:
- Group A: heparin impregnated catheters
- Group B: low-dose unfractionated heparin (100 IU/kg/daily)
- Conditions
- Infection
- Being tested
- heparin impregnated central venous catheters
- Keywords
- central venous catheter, catheter related bloodstream infection, heparin
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin impregnated central venous cathetersDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
Group A: heparin impregnated catheters
Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.
Secondary outcomes (1)
Analysis of variables that may be significant for the development of catheter-related bloodstream infection (catheter-related thrombosis; age; underlying disease; side of venous puncture; duration of catheterization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Centre National de Greffe de Moelle Osseuse
- Sponsor type
- Other government
- Investigators
- Abderrahman Abdelkefi, MD, Principal investigator, Centre National de Greffe de Moelle Osseuse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207779
- Sponsor's protocol ID
- E02
- Status last verified
- Sep 2007
- First submitted
- 13 Sep 2005
- Last updated
- 20 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Catheter-Related Bloodstream Infection in Patients With Haemato-Oncological Disease
- ClinicalTrials.gov ID
- NCT00207779
- Acronym / sponsor ID
- E02
- Conditions
- Infection
- Keywords
- central venous catheter, catheter related bloodstream infection, heparin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Centre National de Greffe de Moelle OsseuseOther government
- Study start
- May 2005
- Study completion
- Aug 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We, the researchers at Centre National de Greffe de Moelle Osseuse, have shown in a randomised study (in press), that a low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease.
The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:
- Group A: heparin impregnated catheters
- Group B: low-dose unfractionated heparin (100 IU/kg/daily)
Detailed description
Studies have shown that catheter-related infection may be due to fibrin deposition associated with catheters. Interventions designed to decrease fibrin deposition and thrombus formation have the potential to reduce catheter-related infections. Seven randomised studies have been performed to assess the safety and efficacy of heparin (either as an infusion or bonded to central venous catheter) on central venous catheter-related bloodstream infections. Although a meta-analysis of 4 studies looking at heparin either as an infusion or bonded to central venous catheter showed a strong trend for a reduction in catheter-related bloodstream infection with the use of heparin, these studies used variable definitions of catheter-related infections.
We have shown in a randomised study (in press), that low dose of unfractionated heparin (100 IU/kg/daily) was safe and effective to prevent catheter-related bloodstream infection in patients with haemato-oncological disease. The aim of this prospective randomised controlled trial is to compare the incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease:
- Group A: heparin impregnated catheters
- Group B: low-dose unfractionated heparin (100 IU/kg/daily)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 4 and 60 years
- Short term non-tunneled percutaneous central venous catheter
Key exclusion criteria (3 listed)
- Presence of a central venous catheter at admission
- Major blood coagulation disorders (platelet count < 50 x 10^9, disseminated intravascular coagulation)
- Absence of catheter-tip culture at the time of catheter removal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heparin impregnated central venous catheters | Device | – |
Primary outcome
Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease
Group A: heparin impregnated catheters
Group B: continuous infusion of low dose unfractionated heparin (100IU/kg/d) through non-impregnated catheter.
1 secondary outcome
Analysis of variables that may be significant for the development of catheter-related bloodstream infection (catheter-related thrombosis; age; underlying disease; side of venous puncture; duration of catheterization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abderrahman Abdelkefi, MD principal investigator
Centre National de Greffe de Moelle Osseuse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing heparin impregnated central venous catheters in people with Infection, run by Centre National de Greffe de Moelle Osseuse at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of catheter-related bloodstream infection in 2 groups of patients with haemato-oncological disease. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2007.