Objective: To determine whether treatment with low dose aspirin and heparin leads to a higher rate of live births than that achieved with low dose aspirin alone in women with a history of recurrent miscarriage associated with phospholipid antibodies (or antiphospholipid antibodies), lupus anticoagulant, and cardiolipin antibodies (or anticardiolipin antibodies). Design: Randomised controlled trial. Setting: Specialist clinic for recurrent miscarriages. Subjects: 90 women (median age 33 (range 22-43)) with a history of recurrent miscarriage (median number 4 (range 3-15)) and persistently positive results for phospholipid antibodies. Intervention: Either low dose aspirin (75 mg daily) or low dose aspirin and 5000 U of unfractionated heparin subcutaneously 12 hourly. All women started treatment with low dose aspirin when they had a positive urine pregnancy test. Women were randomly allocated an intervention when fetal heart activity was seen on ultrasonography. Treatment was stopped at the time of miscarriage or at 34 weeks' gestation. Main outcome measures: Rate of live births with the two treatments. Results: There was no significant difference in the two groups in age or the number and gestation of previous miscarriages. The rate of live births with low dose aspirin and heparin was 71% (32/45 pregnancies) and 42% (19/45 pregnancies) with low dose aspirin alone (odds ratio 3.37 (95% confidence interval 1.40 to 8.10)). More than 90% of miscarriages occurred in the first trimester. There was no difference in outcome between the two treatments in pregnancies that advanced beyond 13 weeks' gestation. Twelve of the 51 successful pregnancies (24%) were delivered before 37 weeks' gestation. Women randomly allocated aspirin and heparin had a median decrease in lumbar spine bone density of 5.4% (range − 8.6% to 1.7%). Conclusion: Treatment with aspirin and heparin leads to a significantly higher rate of live births in women with a history of recurrent miscarriage associated with phospholipid antibodies than that achieved with aspirin alone.

No abstract

1472 Introduction: Despite significant advances in survival rates for pediatric Acute Lymphoblastic Leukemia (ALL) patients (pts), long-term survival rates for adults with ALL have remained below 40%. An absolute lymphocyte count (ALC) < 350/μL at Day 28 of induction therapy is predictive of poor outcome [event-free survival (EFS) and overall survival (OS)] in adults with newly diagnosed ALL. It is unknown, however, whether ALC at Day 28 is also predictive of outcome in those patients who undergo allogeneic HCT in CR1. We hypothesized that the prognostic impact of ALC at Day 28 might be nullified by HCT in CR1 due to the graft versus leukemia effect. Methods: We conducted a retrospective chart review of 90 adult pts (≥ 18 yrs of age) with de novo ALL who underwent HCT while in CR1 during the years 1998–2011 at the Cleveland Clinic and Stanford, 66 of whom were evaluable for data analysis. Institutional review board approval was obtained at each institution. Prior studies identified an ALC of 350/ μL at Day 28 of induction therapy as a cut-off predictive of outcome. Therefore, we evaluated this number as well as other cut-offs. Cytogenetic (CG) risk was ascribed by CALGB criteria. We also evaluated the impact of gender, age at diagnosis, CG, and WBC at diagnosis. The Kaplan-Meier method was used to summarize OS and EFS, which were measured from HCT to death and the first of relapse/death, respectively. The log-rank test was used for univariable analysis of categorical factors and the Cox proportional hazards model, stratified by institution, was used for multivariable analysis and univariable analysis of measured factors. Patient characteristics: Median age: 38 yrs (range 19–66); Gender: 58% (38) male; CG risk: 57 (86%) poor, 5 (8%) miscellaneous, 4 (6%) normal; 64 (97%) B-cell lineage; median WBC at diagnosis 18.1 K/μL (range 0.9–432); median Day 28 ALC 440/μL (range 0–2450). The majority of pts (50, 76%) received a vincristine/prednisone/anthracycline-based induction regimen, with the remainder receiving a high-dose cytarabine based regimen. The median interval between the start of induction and CR was 28 days and the median interval from CR to HCT was 3.2 months (0.2–10.8). Results: Median EFS and OS have not been reached; 1-year EFS is estimated to be 57% ± 6%, and 2-year OS 57% ± 7%. In univariable analyses age > 50 (EFS) and WBC at diagnosis ≥ 40 K/μL (EFS and OS) were associated with worse outcomes (all p ≤ 0.04). A Day 28 ALC < 250/μL (but not < 350/μL) was also associated with decreased EFS [HR 2.27 (1.08–4.79), p=0.03] (Figure 1) with a trend towards worse OS [HR 1.89 (0.89–4.04), p=0.10]. WBC and Day 28 ALC remained statistically significant prognostic factors for RFS on multivariable analysis; HRs 2.89 (1.38–6.05), p=0.005 and 2.25 (1.06–4.78), p=0.04, respectively. Conclusion: ALC at Day 28 remains prognostic for outcome in newly diagnosed ALL pts undergoing HCT in CR1. Further characterization of the lymphocytes in pts with high ALCs and their potential role in preventing relapse is needed. Disclosures: No relevant conflicts of interest to declare.

a regularly scheduled comprehensive review, we are able to track trends on an individual and group basis. Therefore, developing new methods to improve our data prepares us better for challenges of external audits, such as CIBMTR and FACT (Foundation for the Accreditation of Cellular Therapy).

hematopoietic cell transplant (HCT) event. Multiplying this by the number of transplants that are part of the CIBMTR Outcomes Research Database underlines the need for structures that document this 'data about data' (Metadata). The difficulty is showing how the complete set of data around a transplant event is connected in a way that transcends the collection method, i.e. form. Our aim was to demonstrate that a domain-driven architecture aligns with the forms-based model, and eases the introduction of collecting more data about HCT transplant events. The Biomedical Research Integrated Domain Group (BRIDG) model is publically available. The goal of BRIDG group is to have a common view of the data exchanged for semantic interoperability. The BRIDG model is intended to balance the concerns of the larger health care community, while being specific enough to apply to a particular subject area such as HCT. We extracted all Common Data Elements (CDEs) for all CIBMTR-mandated forms and associated each element to one of three contexts, Recipient, Donor and stem-cell product; most elements were in the Recipient context. Because no element could be described in isolation, instance diagrams were created to describe how one simple concept needed multiple BRIDG entities to be fully described. Some CDEs were described as relationships between entities rather than an attribute of an entity. We extended the generic BRIDG model to contain all identified elements. To this end, we requested the expansion of the BRIDG model to include a 'PerformedSubstanceExtraction' entity at the same level of inheritance as 'Perform-edSubstanceAdministration'. While the collection of a stem-cell product could have been described in the context of a 'Product' and a 'SpecimenCollection', the richness of the relationship between a Donor and a Recipient would not have been as obvious. This as well as other enhancements to the BRIDG model were included in BRIDG version 3.2. With this effort, we have documented each data point (CDE) collected on all the CIBMTR-mandated forms and the relationships between them. We intend to use the UML BRIDG model with the added HCT content as the specification for a physical database model. This physical model will help remove barriers that transplant centers experience in electronic transfer of HCT data to the Stem Cell Transplant Outcomes Database by providing a foundation upon which to develop their own in-house data systems, and eventual development of Electronic Medical Record (EMR) integration engines to submit data to the Outcomes Database.