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Accumulation of Nadroparin Used in Renal Insufficiency Assessed by anti-Xa levels.


- candidate number9327
- NTR NumberNTR2850
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-apr-2011
- Secondary IDs 
- Public TitleAccumulation of Nadroparin Used in Renal Insufficiency Assessed by anti-Xa levels.
- Scientific TitleAccumulation of Nadroparin Used in Renal Insufficiency Assessed by anti-Xa levels.
- ACRONYMANURIA
- hypothesisPrevention and treatment of venous thromboembolism (VTE) with low-molecular-weight heparins (LMWHs) is confirmed to be at least as effective as with unfractionated heparin (UFH). In comparison to UFH, the LMWHs have improved pharmacokinetics, ease of administration and lack of need of laboratory monitoring, which has greatly increased the use of LMWHs. Because the elimination of LMWHs is mainly determined by renal excretion, the use of LMWHs in patients with renal insufficiency might lead to accumulation of the drug, accompanied by an increase in anti-Xa level and thereby a greater risk for hemorrhagic complications. In literature, data are available on accumulation of LMWHs in patients with renal insufficiency. However, the rate of accumulation of LMWHs and implications for the dosing regimen of LMWHs is still unclear. In this study we investigate the accumulation of nadroparin used in renal insufficiency assessed by anti-Xa levels.
- Healt Condition(s) or Problem(s) studiedRenal insufficiency, Accumulation, Nadroparin, Anti-Xa level
- Inclusion criteriaPatients are eligible to participate when they comply with the following inclusion criteria:
1. Age at least 18 years;
2. Diagnosed with VTE;
3. First day of therapy with nadroparin;
4. GFR (based on Modification of Diet in Renal Disease (MDRD) calculation) 10-20 ml/min, 20-30 ml/min, 30-40 ml/min, 40-50 ml/min or 50 ml/min or higher (equal distribution of patients to be included over these 5 groups);
5. Treatment dose of nadroparin of at least 7,600 anti-Xa activity IU once daily or 5,700 anti-Xa activity IU twice daily;
6. Subcutaneous nadroparin administration for at least 3 days;
7. Written informed consent.
- Exclusion criteriaPatients are not eligible to participate with respect to the following exclusion criteria:
1. Patients on an intensive care unit (ICU);
2. Prophylactic dosages of nadroparin for VTE;
3. GFR less than 10 ml/ml or dialysis;
4. Severe liver failure;
5. Pregnant patients or patients giving breast feeding;
6. Nadroparin in use for more than 1 day.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mei-2011
- planned closingdate1-mei-2012
- Target number of participants30
- InterventionsNo interventions will be done, as this is an observational study.
- Primary outcomeAnti-Xa levels will be measured 4 hours ( 1 hour) after subcutaneous injection of nadroparin on day 1, day 3 and day 5 of treatment. Primary outcome is the degree of accumulation, defined as the percentage of increase of anti-Xa level on day 5 compared to day 1. This primary outcome will be assessed for various levels of renal function.
- Secondary outcomeSecondary endpoints are the percentage of increase of anti-Xa level on day 3 compared to day 1 and bleeding complications during treatment with nadroparin.
- TimepointsDay 1, day 3 and day 5 of treatment with nadroparin.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES R.R. Boedhram
- CONTACT for SCIENTIFIC QUERIES R.R. Boedhram
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryRationale:
Prevention and treatment of venous thromboembolism (VTE) with low-molecular-weight heparins (LMWHs) is confirmed to be at least as effective as with unfractionated heparin (UFH). In comparison to UFH, the LMWHs have improved pharmacokinetics, ease of administration and lack of need of laboratory monitoring, which has greatly increased the use of LMWHs. Because the elimination of LMWHs is mainly determined by renal excretion, the use of LMWHs in patients with renal insufficiency might lead to accumulation of the drug, accompanied by an increase in anti-Xa level and thereby a greater risk for hemorrhagic complications. In literature, data are available on accumulation of LMWHs in patients with renal insufficiency. However, the rate of accumulation of LMWHs and implications for the dosing regimen of LMWHs is only established in one study previously (Mismetti et al. Aging and Venous Thromboembolism Influence the Pharmacodynamics of the Anti-Factor Xa and Anti-thrombin Activities of a Low Molecular Weight Heparin (Nadroparin). Thromb Haemost 1998; 79: 1162-1165). In this study we investigate the accumulation of nadroparin used in renal insufficiency assessed by anti-Xa levels.

Objective:
The aim of this study is to determine the accumulation of nadroparin used in renal insufficient patients with VTE, by measuring anti-Xa levels.

Study design:
Prospective, observational, follow-up study.

Study population:
Hospitalised adult patients with VTE and renal insufficiency (defined as a glomerular filtration rate (GFR) of less than 50 ml/min) to whom subcutaneous nadroparin is administered on general medical or surgical departments of the Erasmus MC in Rotterdam, the Netherlands.

Main study parameters/endpoints:
Anti-Xa levels will be measured 4 hours ( 1 hour) after subcutaneous injection of nadroparin on day 1, day 3 and day 5 of treatment. Primary outcome is the degree of accumulation, defined as the percentage of increase of anti-Xa level on day 5 compared to day 1. This primary outcome will be assessed for various levels of renal function. Secondary endpoints are the percentage of increase of anti-Xa level on day 3 compared to day 1 and bleeding complications during treatment with nadroparin.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The patient will be asked for 3 blood samples of 4.5 ml to measure the anti-Xa level during treatment with nadroparin. Standard care will be provided, so if the doctor does not decide to measure anti-Xa himself, then the anti-Xa analyses will take place in batches after day 5 of treatment with nadroparin (and thus the values will not be used to adjust therapy during the study period). If still relevant (i.e. when nadroparin is still in use) the anti-Xa levels will be communicated to the doctor after day 5.
- Main changes (audit trail)
- RECORD14-apr-2011 - 28-apr-2011


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