Haemorrhagic cystitis in haematopoietic stem cell transplantation (HSCT): a prospective observational study of incidence and management in HSCT centres within the GITMO network (Gruppo Italiano Trapianto Midollo Osseo).

UNLABELLED: Haemorrhagic cystitis (HC) is a recognised complication in patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT). This study evaluates the incidence and severity of HC in patients undergoing allogeneic HSCT during hospitalisation and within the first 100 days following transplant, looking at the use of prophylaxis, management of HC, outcomes at 100 days post transplant, and to identify any correlations between development of HC and the different conditioning regimens for transplant or HC prevention methods used. RESULTS: Four hundred and fifty patients (412 adult and 38 paediatric) were enrolled in this prospective, multicentre, and observational study. HC was observed in 55 patients (12.2%) of which 8/38 were paediatric (21% of total paediatric sample) and 47/412 adults (11.4% of total adult sample). HC was observed primarily in the non-related HSCT group (45/55; 81.8%, p= 0.001) compared to sibling and myeloablative transplant protocols (48/55; 87.3%; p= 0.008) and with respect to reduced intensity conditioning regimens (7/55;12.7%). In 33 patients with HC (60%), BK virus was isolated in urine samples, a potential co-factor in the pathogenesis of HC. The median day of HC presentation was 23 days post HSCT infusion, with a mean duration of 20 days. The most frequent therapeutic treatments were placement of a bladder catheter (31/55; 56%) and continuous bladder irrigation (40/55; 73%). The range of variables in terms of conditioning regimens and so on, makes analysis difficult. CONCLUSIONS: This multi-centre national study reported similar incidence rates of HC to those in the literature. Evidence-based guidelines for prophylaxis and management are required in transplant centres. Further research is required to look at both prophylactic and therapeutic interventions, which also consider toxicity of newer conditioning regimens.

Incidence and severity of oral mucositis in patients undergoing haematopoietic SCT--results of a multicentre study.

Oral mucositis (OM) is a common side effect experienced during haematopoietic SCT (HSCT), and it can have a significant impact on the quality of life of patients. A descriptive nurse-led study was undertaken in 19-member centres of the Italian national transplant group (GITMO) evaluating incidence, severity and duration of OM in patients undergoing HSCT. Data from 1841 patients between 2002 and 2006 was analyzed. Initial medical history and oral cavity assessment was performed. Assessment was repeated on the day of transplant, then daily, using the WHO (World Health Organisation) oral toxicity scale. A total of 71% of the patients evaluated developed mucositis and 21.6% developed severe mucositis. Duration of OM in most cases lasted for 10-14 days and resolved along with marrow reconstitution. Oral mucostitis is a frequent side effect in patients undergoing HSCT. The onset of severe mucositis seems to be related to the conditioning regimen used. This database provides a descriptive overview of the incidence and severity of mucositis and has encouraged participating centres to adopt routine evaluation and measurement of the oral cavity. The assessment tools are still used in some centres, providing a basis for further collaborative research projects.

Cryotherapy in the prevention of oral mucositis in patients receiving low-dose methotrexate following myeloablative allogeneic stem cell transplantation: a prospective randomized study of the Gruppo Italiano Trapianto di Midollo Osseo nurses group.

Severe oral mucositis is a major cause of morbidity following allogeneic hematopoietic stem cell transplantation (AHSCT). Cryotherapy, that is, the application of ice chips on the mucosa of the oral cavity during the administration of antineoplastic agents, may reduce the incidence and severity of chemotherapy-related oral mucositis. In this multicenter randomized study, we addressed whether cryotherapy during MTX administration is effective in the prevention of severe oral mucositis in patients undergoing myeloablative AHSCT. One hundred and thirty patients undergoing myeloablative AHSCT and MTX-containing GVHD prophylaxis were enrolled and randomized to receive or not receive cryotherapy during MTX administration. The incidence of severe (grade 3-4) oral mucositis, the primary end point of the study, was comparable in patients receiving or not cryotherapy. Moreover, no difference was observed in the incidence of oral mucositis grade 2-4 and the duration of oral mucositis grade 3-4 or 2-4, or in the kinetics of mucositis over time. In univariate and multivariate analysis, severe oral mucositis correlated with TBI in the conditioning regimen and lack of folinic acid rescue following MTX administration. Thus, cryotherapy during MTX administration does not reduce severe oral mucositis in patients undergoing myeloablative allogeneic HSCT. Future studies will assess cryotherapy before allogeneic HSCT.

[Comparison of two different protocols on change of medication in central venous catheterization in patients with bone marrow transplantation: results of a randomized multicenter study]. / Confronto di due differenti protocolli nell'intervallo del cambio di medicazione per cateteri venosi centrali in pazienti trapiantati di midollo osseo: risultati di uno studio multicentrico randomizzato. Gruppo Italiano di Infermieri Trapianto Midollo Osseo (GITMO).

Care of central venous catheter (CVC) in patients undergoing bone marrow transplantation (BMT) raises significant problems related to the high risk of local infections, to the immunodeficient status, which in itself is a predisposing factor for systematic blood stream infections. Although frequent changes of CVC dressing might theoretically reduce the incidence of infections, they are also accompanied by significant skin toxicity and patient discomfort. No study has yet addressed these points. The objective of this study was to compare two different time interval protocols for CVC dressing, in order to assess the effects on local infections and toxicity. In a multicentre study, 339 bone marrow transplant (BMT) patients with a tunnelled CVC (group A, 230 pts) or a non tunnelled one (Group B, 169 patients) were randomly allocated to receive CVC dressing changes every 5 or 10 days if belonging to group A or 2 or 5 days if in group B. Transparent impermeable polyurethane dressings were used for all patients. The rate of local infection at the site of CVC insertion was assessed by microbiological assay every 10 days, while severity of skin toxicity was measured according to the ECOG scale. Sixty-five per cent of enrolled patients were finally evaluable. Patients (in both groups) receiving CVC dressing changes at longer intervals did not show a significant increase in the rate of local infections, while those who received dressing every two days had a significant increase in local skin toxicity. Longer intervals were accompanied by a reduction in costs. The results of this study demonstrate that the increase in time interval between CVC dressing changes in BMT patients did not increment the risk of local infections, while significantly reducing patients discomfort and costs.

Comparison of two different time interval protocols for central venous catheter dressing in bone marrow transplant patients: results of a randomized, multicenter study. The Italian Nurse Bone Marrow Transplant Group (GITMO).

BACKGROUND AND OBJECTIVE: Care of central venous catheter (CVC) in patients undergoing bone marrow transplantation (BMT) raises significant problems related to the high risk of local infections due to the immunodeficient status, which in itself is a predisposing factor for systemic blood-stream infections. Although frequent changes of CVC dressing might theoretically reduce the incidence of infections, they are also accompanied by significant skin toxicity and patient discomfort. No study has yet addressed these points. The objective of this study was to compare two different time interval protocols for CVC dressing in order to assess the effects on local infections and toxicity. DESIGN AND METHODS: In a multicenter study, 399 bone marrow transplant (BMT) patients with a tunneled CVC (Group A, 230 pts) or a non-tunneled one (Group B, 169 pts) were randomly allocated to receive CVC dressing changes every 5 or 10 days, if belonging to Group A, or 2 or 5 days, if in Group B. Transparent, impermeable polyurethane dressings were used for all patients. The rate of local infections at the site of CVC insertion was assessed by microbiological assays every 10 days, while the severity of skin toxicity was measured according to the ECOG scale. RESULTS: Sixty-five per cent of enrolled patients were finally evaluable. Patients (in both Groups) receiving CVC dressing changes at longer intervals did not show a significant increase in the rate of local infections, while those who received dressing every 2 days had a significant increase in local skin toxicity. Longer intervals were accompanied by a reduction in costs. INTERPRETATION AND CONCLUSIONS: The results of this study demonstrate that the increase in time interval between CVC dressing changes in BMT patients did not raise the risk of local infections, while significantly reducing patient discomfort and costs.