Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.
This is a retrospective case-note review of adults undergoing haematopoietic cell transplantation to treat a haematological malignancy who have been admitted to Hammersmith Hospital from 2000 to 2014. All patients receiving an allogeneic haematopoietic cell transplant from a matched sibling or identically matched unrelated donor will be included. We will record the route and assess the broad adequacy of nutritional intakes to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation. Our outcomes are graft versus host disease incidence and severity, transplant related (early) mortality and overall survival.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for > 20 years by most transplant centres to improve comparability between publications. | 100 days after the date of hematopoietic cell infusion |
| Non Relapse Mortality | Defined as death without previous relapse | 100 days after the date of hematopoietic cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Graft Versus Host Disease-free and Relapse-free Survival | GvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death | 5 years after the date of hematopoietic cell infusion |
| 5 Year Survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients aged 17 or above who underwent their first HCT for hematologic malignancy at Hammersmith Hospital, using a sibling or unrelated donor between January 2000 and December 2014
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Adequate Enteral Nutrition | Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding. |
| FG001 | Adequate Parenteral Nutrition | Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition. |
| FG002 | Inadequate Nutrition | Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adequate Enteral Nutrition | Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding. |
| BG001 | Adequate Parenteral Nutrition |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Acute Graft Versus Host Disease (GvHD) at Any Site (Grade II or Above) and Acute GvHD of the Gut of Any Grade | Occurrence of acute GvHD at any site (grade II or above) and acute GvHD of the gut of any grade (graded according to standard criteria). Standard criteria to grade the severity of acute GvHD are quantification of rash, serum bilirubin and diarrhoea. These standard criteria have been developed and used for > 20 years by most transplant centres to improve comparability between publications. | There were 439 and 438 evaluable cases respectively for acute GvHD grade II or greater and gastrointestinal acute GvHD of any grade after exclusion of patients that died before day 100 without acute GvHD. | Posted | Count of Participants | Participants | 100 days after the date of hematopoietic cell infusion |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adequate Enteral Nutrition | Adequate nutrition in the period to engraftment after transplant, in those patients nourished orally or any patient that required 4 or more days of enteral tube feeding. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Beckerson | Imperial College Healthcare NHS Trust | 02033131922 | julie.beckerson@nhs.net |
Not provided
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| D019337 | Hematologic Neoplasms |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 5 years after the date of hematopoietic cell infusion |
Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition. |
| BG002 | Inadequate Nutrition | Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Diagnosis | Count of Participants | Participants |
|
| European Group for Blood and Marrow Transplantation (EBMT)disease risk | The European Group for Blood and Marrow Transplantation (EBMT) risk score provides a simple tool to assess instantly chances and risks of hematopoietic SCT(HSCT) for an individual patient pre-transplant. Five factors, age of the patient, stage of the disease, time from diagnosis, donor type and donor recipient gender combination augment risk for an individual patient with increasing score from 0 as best to 7 as worst in an additive way. Early stage disease represents the better expected outcome. | Count of Participants | Participants |
|
| BMI (kg/m^2) | Count of Participants | Participants |
|
| Donor match | Count of Participants | Participants |
|
| Conditioning | Count of Participants | Participants |
|
| Previous autograft | Count of Participants | Participants |
|
| Patient / Donor Sex | Count of Participants | Participants |
|
| Patient cytomegalovirus (CMV) serology | Count of Participants | Participants |
|
| Donor CMV serology | Count of Participants | Participants |
|
| Cells infused | Count of Participants | Participants |
|
| Cluster of differentiation 34 (CD34+) cells infused | Count of Participants | Participants |
|
| Era (years) | Count of Participants | Participants |
|
| Hematopoietic cell transplant co-morbidity index (HCT-CI) | The hematopoietic cell transplantation-comorbidity index (HCT-CI) is a comorbidity tool suited for recipients of HCT. The index has been shown to sensitively capture the prevalence and magnitude of severity of various organ impairments before HCT and to provide valuable prognostic information after HCT. The higher the comorbidities the worse the expected outcome. | Count of Participants | Participants |
|
| OG001 | Adequate Parenteral Nutrition | Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition. |
| OG002 | Inadequate Nutrition | Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment. |
|
|
| Primary | Non Relapse Mortality | Defined as death without previous relapse | Posted | Mean | 95% Confidence Interval | percentage of participants | 100 days after the date of hematopoietic cell infusion |
|
|
|
| Secondary | Graft Versus Host Disease-free and Relapse-free Survival | GvHD-free/relapse-free survival (GRFS). Events in GRFS included grade 3-4 acute GvHD, systemic therapy-requiring chronic GvHD, relapse, or death | Posted | Mean | 95% Confidence Interval | percentage of participants | 5 years after the date of hematopoietic cell infusion |
|
|
|
| Secondary | 5 Year Survival | Posted | Mean | 95% Confidence Interval | percentage of participants | 5 years after the date of hematopoietic cell infusion |
|
|
|
| 0 |
| 245 |
| 0 |
| 245 |
| EG001 | Adequate Parenteral Nutrition | Patients that were adequately nourished during the period to engraftment after transplant, that received 4 or more days of parenteral nutrition. | 0 | 148 | 0 | 148 |
| EG002 | Inadequate Nutrition | Those with inadequate oral in take and a documented unmet need for artificial nutrition support for 4 or more days before engraftment. | 0 | 91 | 0 | 91 |
Not provided
Not provided
Not provided
| D006425 |
| Hemic and Lymphatic Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |