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Because the inclusion rate was lower than expected.
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| Name | Class |
|---|---|
| Dirinco B.V. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| B: concentrated citrate (Citralock) | Experimental | locking the central venous catheter with concentrated citrate after each use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heparin | Procedure | when not in use CVCs are locked with heparin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | weekly from date of randomization until removal of the central venous catheter, up to one year |
| central venous catheter-related infections | weekly from date of randomization untill the removal of the central venous catheter; up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| premature removal of the catheter | weekly from date of randomization untill removal of the central venous catheter; up to one year | |
| failure to aspirate blood | weekly from date of randomization untill the removal of the central venous catheter; up to one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harry Schouten, MD | Maastricht University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Medical Center Parkstad Heerlen | Heerlen | 6419PC | Netherlands | |||
| Maastricht University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17962211 | Background | 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. | |
| 17897607 | Background | Raad 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. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D016470 | Bacteremia |
| D013927 | Thrombosis |
| D055499 | Catheter-Related Infections |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| concentrated citrate |
| Procedure |
when not in use the CVC is locked with concentrated citrate |
|
| hypocalcemic symptoms | weekly from dateof randomization untill the removal of the central venous catheter; up to one year |
| severe bleeding | weekly from date of randomization untill the removal of the central venous catheter; up to one year |
| Maastricht |
| 6202AZ |
| Netherlands |
| 16033861 | Background | Weijmer 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. |
| D001424 |
| Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |