Annals of hematology
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Annals of hematology · Aug 2013
Randomized Controlled Trial Multicenter Study Comparative StudyHigh-dose imatinib versus high-dose imatinib in combination with intermediate-dose cytarabine in patients with first chronic phase myeloid leukemia: a randomized phase III trial of the Dutch-Belgian HOVON study group.
Despite the revolutionary change in the prognosis of chronic myeloid leukemia (CML) patients with the introduction of imatinib, patients with resistant disease still pose a considerable problem. In this multicenter, randomized phase III trial, we investigate whether the combination of high-dose imatinib and intermediate-dose cytarabine compared to high-dose imatinib alone, improves the rate of major molecular response (MMR) in newly diagnosed CML patients. This study was closed prematurely because of declining inclusion due to the introduction of second generation tyrosine kinase inhibitors and only one third of the initially required patients were accrued. ⋯ The addition of intermediate-dose of cytarabine to imatinib did not improve the MMR rate at 12 months. However, the underpowering of the study precludes any definitive conclusions. This trial is registered at www.trialregister.nl (NTR674).
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Annals of hematology · Sep 2012
Randomized Controlled Trial Comparative StudyA randomized comparison of cyclophosphamide vs. reduced dose cyclophosphamide plus fludarabine for allogeneic hematopoietic cell transplantation in patients with aplastic anemia and hypoplastic myelodysplastic syndrome.
Recently, a less toxic regimen comprising reduced cyclophosphamide (Cy), fludarabine, and anti-thymocyte globulin (ATG) (Cy-Flu-ATG) was used to condition high-risk patients scheduled for allogeneic hematopoietic cell transplantation (alloHSCT) instead of standard Cy-ATG in patients with severe aplastic anemia (AA). We performed a randomized phase III study to compare the regimen-related toxicities (RRTs) of two different conditioning regimens: Cy-ATG vs. Cy-Flu-ATG. ⋯ There was no difference in neutrophil engraftment failure (2.5 vs. 2.33 %; p = 0.959), acute graft-versus-host disease (GvHD) (15.0 vs. 23.3 %; p = 0.388), and chronic GvHD (16.7 vs. 16.2 %; p = 0.961) between Cy-ATG and Cy-Flu-ATG arms. The 4-year survival rate did not differ between the Cy-ATG and Cy-Flu-ATG arms. Preconditioning with Cy-Flu-ATG was superior to that afforded by Cy-ATG in terms of reducing RRT levels without increasing engraftment failure.
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Annals of hematology · Dec 2010
Randomized Controlled TrialCentral venous catheter-associated bloodstream infection and colonisation of insertion site and catheter tip. What are the rates and risk factors in haematology patients?
Skin colonisation is an important source for central venous catheter (CVC) colonisation and infection. This study intended to identify risk factors for skin colonisation prior to CVC placement (baseline colonisation) and within 10 days after CVC insertion (subsequent colonisation), for CVC-tip colonisation and for bloodstream infection (BSI). Within a randomised clinical trial, data of 219 patients with haematological malignancies and inserted CVC (with a total of 5,501 CVC-days and 4,275 days at risk) in two university hospitals were analysed. ⋯ High level of skin colonisation predicts catheter tip colonisation and possibly subsequent infection. Sustained reduction of bacterial growth at the CVC insertion site is therefore indispensable. Male patients are at particular risk for skin colonisation and may be a target population for additional insertion-site care before and during catheterisation.
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Annals of hematology · Mar 2009
Randomized Controlled Trial Comparative StudyPrevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial.
The objective of the study was to evaluate the effectiveness of chlorhexidine-impregnated sponges for reducing catheter-related infections of central venous catheters inserted for cancer chemotherapy. The method used was a randomized, prospective, open, controlled clinical study (three-step group sequential analysis protocol). The patients were from two high dependency units at a university hospital undergoing chemotherapy for haematological or oncological malignancies requiring central venous catheters (CVCs) expected to remain in place for at least 5 days. ⋯ Especially, catheter-related infections at internal jugular vein insertions could be reduced (p=0.018). No adverse effects related to the intervention were observed. The use of chlorhexidine-impregnated wound dressings significantly reduced the incidence of CVC-related infections in patients receiving chemotherapy.
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Annals of hematology · Sep 2006
Randomized Controlled Trial Clinical TrialBody iron and individual iron prophylaxis in pregnancy--should the iron dose be adjusted according to serum ferritin?
This study aims to evaluate iron prophylaxis in pregnant women from the individual aspect, i.e. according to serum ferritin levels at the beginning of pregnancy, and to assess which dose of iron would be adequate to prevent iron deficiency (ID) and iron deficiency anaemia (IDA) during pregnancy and postpartum. A randomised, double-blind study comprising 301 healthy Danish pregnant women allocated into four groups taking ferrous iron (as fumarate) in doses of 20 mg (n=74), 40 mg (n=76), 60 mg (n=77) and 80 mg (n=75) from 18 weeks gestation (inclusion) to 8 weeks postpartum. Iron status markers [serum ferritin, serum soluble transferrin receptor (sTfR), haemoglobin] were recorded at 18, 32 and 39 weeks gestation and 8 weeks postpartum. ⋯ In the prevention of ID, we suggest 80-100 mg ferrous iron/day to women having ferritin
70 microg/l have no need for iron supplement.