British journal of haematology
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Randomized Controlled Trial Multicenter Study
Abnormalities of chromosome 1p/q are highly associated with chromosome 13/13q deletions and are an adverse prognostic factor for the outcome of high-dose chemotherapy in patients with multiple myeloma.
The prognostic value of chromosomal abnormalities was studied in untreated multiple myeloma patients who were registered into a prospective randomised multicentre phase 3 study for intensified treatment (HOVON24). A total of 453 patients aged less than 66 years with stage II and III A/B disease were registered in the clinical study. Cytogenetic analysis was introduced as a standard diagnostic assay in 1998. ⋯ Patients with karyotypic abnormalities had a significantly shorter overall survival (OS) than patients with normal karyotypes. Complex abnormalities, hypodiploidy, chromosome 1p abnormalities, chromosome 1q abnormalities, and chromosome 13 abnormalities were associated with inferior OS on univariate analysis, as well as after adjustment for other prognostic factors. In conclusion, chromosome 13 abnormalities and chromosome 1p and/or 1q abnormalities were highly associated, and are risk factors for poor outcome after intensive therapy in multiple myeloma.
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Multicenter Study
Incidence of thrombotic complications in patients with haematological malignancies with central venous catheters: a prospective multicentre study.
This prospective, observational and multicentre study assessed the incidence of, and risk factors for, symptomatic venous thrombotic complications after central venous catheter (CVC) positioning in patients with haematological malignancies. A total of 458 consecutive CVC insertions were registered in 416 patients (81.2% of whom had severe thrombocytopenia). Over the observation period (3 months or up to catheter removal), the incidence of events was: CVC-related deep vein thrombosis (DVT), 1.5%; lower limb DVT, 0.4%; pulmonary embolism (PE), 1.3%; fatal PE, 0.6%; CVC-related superficial thrombophlebitis, 3.9%; CVC-occlusion/malfunction of thrombotic origin, 6.1%; major arterial events, 1.1%. ⋯ No factor helped to predict venous thrombotic complications: only thrombocytopenia was associated with a weak trend for a reduced risk (odds ratio 0.52; 95% confidence interval 0.26-1.07). No severe bleeding was observed in those patients who received antithrombotic prophylaxis. This study shows that the impact on clinical practice of symptomatic CVC-related thrombotic complications is not negligible in patients with haematological malignancies.
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Multicenter Study
Reduced efficacy of clinical probability score and D-dimer assay in elderly subjects suspected of having deep vein thrombosis.
The combined strategy of a pretest clinical probability (PCP) score and D-dimer has shown to be of value in the diagnosis of deep vein thrombosis (DVT). As D-dimer concentrations increase with age, the effect of age on the usefulness of this strategy was retrospectively investigated in outpatients suspected of having DVT. In all patients, participants of a prospective management trial, a PCP score and D-dimer (Tina-quant) were performed. ⋯ Specificity in the highest quartile was 17.4% compared with 49.2% in the youngest (P < 0.000001). The proportion of patients with a low/moderate PCP score and a normal D-dimer decreased with age: 12% in the highest quartile (>73.8 years) versus 25% in younger patients (P = 0.00005). We therefore conclude that the combined strategy of a low/moderate PCP score with a normal D-dimer test is safe for excluding DVT in all age groups, but is less useful in the elderly.
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Multicenter Study Clinical Trial
Autologous bone marrow transplantation in the treatment of refractory systemic sclerosis: early results from a French multicentre phase I-II study.
Haematopoietic stem cell transplantation (HSCT) has been proposed for refractory autoimmune diseases, including systemic sclerosis (SSc). A sequential Bayesian phase I-II clinical trial was conducted in SSc patients to assess the feasibility, the tolerance and the efficacy of autologous HSCT. Peripheral blood stem cells (PBSC) were collected using cyclophosphamide (4 g/m2) and recombinant human granulocyte colony-stimulating factor (5 micro g/kg/d) and reinfused after positive CD34+ selection. ⋯ Median time to neutrophil (> 0.5 x 10(9)/l) and platelet (> 25 x 10(9)/l) haematopoietic reconstitution was 12 and 10 d respectively. After 18 months (range 1-26), eight out of 11 patients have shown major or partial response. Non-myeloablative conditioning, followed by a T cell-depleted autologous PBSC or bone marrow transplantation, appears feasible with low toxicity in severe SSc with short-term clinical benefits.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Occurrence of thrombosis and haemorrhage, relationship with anti-Xa, anti-IIa activities, and D-dimer plasma levels in patients receiving a low molecular weight heparin, enoxaparin or tinzaparin, to prevent deep vein thrombosis after hip surgery.
Studies in experimental animal models and in patients receiving low molecular weight heparin (LMWH) to prevent thromboembolic events after surgery have not demonstrated a clear relationship between anti-Xa and anti-IIa activities in plasma and either bleeding or prevention of thrombosis. The relationship between these clinical outcomes and ex vivo anti-Xa and anti-IIa activities, activated partial thromboplastin time (APTT) and D-dimers were evaluated in 440 patients undergoing total hip replacement and given prophylaxis once daily with a LMWH (tinzaparin or enoxaparin) in a multicentre double-blind randomized study. 221 patients received 4500 anti-Xa IU of tinzaparin; 219 patients received 40 mg (4000 anti-Xa IU) of enoxaparin. Both regimens were administered subcutaneously once daily. ⋯ This was also true with regards to APTT. Before and after surgery, D-dimers were significantly higher in patients with deep vein thrombosis (DVT) than in those without DVT but had no predictive value. Interestingly, a significant post-operative increase of D-dimers persisted in both groups of patients during the whole observation period, possibly suggesting that a longer duration of prophylactic treatment may be appropriate.