Hematological MalignanciesPhase 3NCT01820962
Concentrated Citrate Locking to Reduce the Incidence of CVC-related Complications in Hematological Patients
A Phase 3 study testing heparin and concentrated citrate in people with Hematological Malignancies and Bacteremia, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial summary
Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies, Bacteremia, Thrombosis
- What is being tested?
- heparin and concentrated citrate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 2 sitesNetherlands
- Study dates
- Jul 2006to Jul 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with hematological malignancies who were going to receive a CVC for intensive chemotherapy including patients for stem cell transplantation
- written informed consent
- 18 years or older
Who cannot join
- the presence of a central venous catheter at admission
- history of central venous catheter related thrombosis or infection
- indication for anticoagulant treatment or prophylaxis
- patients with totally implanted catheters
- catheters impregnated with antimicrobial agents
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Atrium Medical Center Parkstad Heerlen
Heerlen, 6419PC
Maastricht University Medical Center
Maastricht, 6202AZ
About this study
Official title: Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population
Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.
The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.
Read the detailed description
Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.
At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis patients.
- Conditions
- Hematological Malignancies, Bacteremia, Thrombosis
- Being tested
- heparin, concentrated citrate
- Keywords
- hematological patients, central venous catheters, catheter related thrombosis, catheter related infections, concentrated citrate
- Medical subject headings
- Hematologic Neoplasms, Bacteremia, Thrombosis, Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparinProcedure or surgery
when not in use CVCs are locked with heparin
concentrated citrateProcedure or surgery
when not in use the CVC is locked with concentrated citrate
| Study group | Role | What they receive |
|---|---|---|
| A: heparin (Heparin LEO) | Active comparator | After each use, the central venous catheter lumen will be flushed with 10 ml 0.9% NaCl and then locked with heparin 5000 IU/ml(standard treatment)using a volume exactly equivalent to the internal volume noted on each catheter. Receives: Procedure: heparin |
| B: concentrated citrate (Citralock) | Experimental | locking the central venous catheter with concentrated citrate after each use Receives: Procedure: concentrated citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
central venous catheter-related thrombosis
Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.
Measured: weekly from date of randomization until removal of the central venous catheter, up to one year
central venous catheter-related infections
Measured: weekly from date of randomization untill the removal of the central venous catheter; up to one year
Secondary outcomes (4)
premature removal of the catheter
Measured: weekly from date of randomization untill removal of the central venous catheter; up to one year
failure to aspirate blood
Measured: weekly from date of randomization untill the removal of the central venous catheter; up to one year
hypocalcemic symptoms
Measured: weekly from dateof randomization untill the removal of the central venous catheter; up to one year
severe bleeding
Measured: weekly from date of randomization untill the removal of the central venous catheter; up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startJul 2006
- Primary completionDec 2010
- Study completionJul 2012
Why it stopped: Because the inclusion rate was lower than expected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dirinco B.V.
- Responsible party
- Sponsor
- Investigators
- Harry Schouten, MD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820962
- Sponsor's protocol ID
- MEC06-2-003
- Status last verified
- Mar 2013
- First submitted
- 12 Mar 2013
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Boersma RS, Jie KS, Verbon A, van Pampus EC, Schouten HC. Thrombotic and infectious complications of central venous catheters in patients with hematological malignancies. Ann Oncol. 2008 Mar;19(3):433-42. doi: 10.1093/annonc/mdm350. Epub 2007 Oct 24.
PubMed 17962211Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.
PubMed 17897607Weijmer MC, van den Dorpel MA, Van de Ven PJ, ter Wee PM, van Geelen JA, Groeneveld JO, van Jaarsveld BC, Koopmans MG, le Poole CY, Schrander-Van der Meer AM, Siegert CE, Stas KJ; CITRATE Study Group. Randomized, clinical trial comparison of trisodium citrate 30% and heparin as catheter-locking solution in hemodialysis patients. J Am Soc Nephrol. 2005 Sep;16(9):2769-77. doi: 10.1681/ASN.2004100870. Epub 2005 Jul 20.
PubMed 16033861
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrated Citrate Locking to Reduce the Incidence of Central Venous Catheter-related Infections and Thrombosis: a Randomized Phase III Study in a Hematological Patient Population
- ClinicalTrials.gov ID
- NCT01820962
- Acronym / sponsor ID
- MEC06-2-003
- Conditions
- Hematological Malignancies, Bacteremia, Thrombosis
- Keywords
- hematological patients, central venous catheters, catheter related thrombosis, catheter related infections, concentrated citrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because the inclusion rate was lower than expected.
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Dirinco B.V.
- Study start
- Jul 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Mar 2013 (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.
Patients with a hematological malignancy who are undergoing intensive chemotherapy need a central venous catheter (CVC)during their treatment. CVCs are locked with heparin when they are not used.
The purpose of this study is to determine whether concentrated citrate locking, compared to heparin, reduces the incidence of central venous catheter-related thrombosis and infections in patients with hematological malignancies undergoing intensive chemotherapy.
Detailed description
Central venous catheter (CVC)-related thrombosis and infections are frequently occurring complications and may cause significant morbidity in patients with hematological malignancies. Interventions to decrease fibrin deposition have the potential to reduce CVC-related thrombosis and infections.
At present heparin is most often used as locking solution for central venous catheters in hematological patients despite a lack of evidence regarding the efficacy and safety. Trisodium citrate (TSC) had been shown to be an effective antimicrobial catheter locking in hemodialysis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: heparin (Heparin LEO) | Active comparator | Procedure: heparinAfter each use, the central venous catheter lumen will be flushed with 10 ml 0.9% NaCl and then locked with heparin 5000 IU/ml(standard treatment)using a volume exactly equivalent to the internal volume noted on each catheter. |
| B: concentrated citrate (Citralock) | Experimental | Procedure: concentrated citratelocking the central venous catheter with concentrated citrate after each use |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with hematological malignancies who were going to receive a CVC for intensive chemotherapy including patients for stem cell transplantation
- written informed consent
- 18 years or older
Key exclusion criteria (5 listed)
- the presence of a central venous catheter at admission
- history of central venous catheter related thrombosis or infection
- indication for anticoagulant treatment or prophylaxis
- patients with totally implanted catheters
- catheters impregnated with antimicrobial agents
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 |
|---|---|---|
| heparinwhen not in use CVCs are locked with heparin | Procedure or surgery | A: heparin (Heparin LEO) |
| concentrated citratewhen not in use the CVC is locked with concentrated citrate | Procedure or surgery | B: concentrated citrate (Citralock) |
Primary outcome
central venous catheter-related thrombosis
Time frame: weekly from date of randomization until removal of the central venous catheter, up to one year
Patients will be followed from insertion of the central venous catheter till removal of the central venous catheter, an expected average of 30 days. The central venous catheter is seen daily and checked for thrombosis and infections when the patient is admitted on the ward. Discharged patients are seen at least weekly on the outpatients clinic and their central venous catheter is checked for thrombosis and infections. A standard ultrasound is made 30 days after insertion and within 24 hours after removal of the central venous catheter.
central venous catheter-related infections
Time frame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
4 secondary outcomes
premature removal of the catheter
Time frame: weekly from date of randomization untill removal of the central venous catheter; up to one year
failure to aspirate blood
Time frame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
hypocalcemic symptoms
Time frame: weekly from dateof randomization untill the removal of the central venous catheter; up to one year
severe bleeding
Time frame: weekly from date of randomization untill the removal of the central venous catheter; up to one year
Results and safety
The study was stopped early (reason given: Because the inclusion rate was lower than expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Background: PubMed 17962211Boersma RS, Jie KS, Verbon A, van Pampus EC, Schouten HC. Thrombotic and infectious complications of central venous catheters in patients with hematological malignancies. Ann Oncol. 2008 Mar;19(3):433-42. doi: 10.1093/annonc/mdm350. Epub 2007 Oct 24.
- Background: PubMed 17897607Raad I, Hanna H, Maki D. Intravascular catheter-related infections: advances in diagnosis, prevention, and management. Lancet Infect Dis. 2007 Oct;7(10):645-57. doi: 10.1016/S1473-3099(07)70235-9.
- Background: PubMed 16033861Weijmer MC, van den Dorpel MA, Van de Ven PJ, ter Wee PM, van Geelen JA, Groeneveld JO, van Jaarsveld BC, Koopmans MG, le Poole CY, Schrander-Van der Meer AM, Siegert CE, Stas KJ; CITRATE Study Group. Randomized, clinical trial comparison of trisodium citrate 30% and heparin as catheter-locking solution in hemodialysis patients. J Am Soc Nephrol. 2005 Sep;16(9):2769-77. doi: 10.1681/ASN.2004100870. Epub 2005 Jul 20.
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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.
Harry Schouten, MD principal investigator
Maastricht University Medical Centre
2 sites 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 and concentrated citrate in people with Hematological Malignancies and Bacteremia, run by Maastricht University Medical Center at 2 sites in Netherlands.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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 was stopped early (reason given: Because the inclusion rate was lower than expected.). Results are not available in the source record.
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?
central venous catheter-related thrombosis (time frame: weekly from date of randomization until removal of the central venous catheter, up to one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01820962, which also lists 3 linked publications.
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 29 Mar 2013.