Julie Carruthers

A pilot randomized trial of adjuvant rituximab or placebo for nonsplenectomized patients with immune thrombocytopenia

The benefit of adding rituximab to standard treatment in nonsplenectomized patients with primary immune thrombocytopenia (ITP) is uncertain. We performed a pilot randomized trial to determine the feasibility of recruitment, protocol adherence, and blinding of a larger trial of rituximab versus placebo; and to evaluate the potential efficacy of adjuvant rituximab in ITP. Nonsplenectomized adults with newly diagnosed or relapsed ITP who were receiving standard ITP therapy for a platelet count below 30 × 10(9)/L were randomly allocated to receive 4 weekly infusions of 375 mg/m(2) rituximab or saline placebo. Sixty patients were recruited over 46 months, which was slower than anticipated. Protocol adherence and follow-up targets were achieved, and blinding was successful for research staff but not for patients. After 6 months, there was no difference between rituximab and placebo groups for the composite outcome of any platelet count below 50 × 10(9)/L, significant bleeding or rescue treatment once standard treatment was stopped (21/32 [65.6%] vs 21/26 [80.8%]; relative risk = 0.81, 95% confidence intervals, 0.59%-1.11%). Timely accrual poses a challenge to the conduct of a large randomized trial of rituximab for presplenectomy ITP. No difference in the frequency of the composite outcome was observed in this pilot trial (registered at www.clinicaltrials.gov NCT00372892).

Comparing hand‐held computers and paper diaries for haemophilia home therapy: a randomized trial

Summary.  Treatment of severe haemophilia with factor concentrates is by self‐infusion in the home. Adherence to record keeping on paper diaries is poor. A randomized‐controlled trial compared adherence with record keeping of paper diaries with hand‐held computers. Forty‐one individuals with severe haemophilia, were randomized to hand‐held computers (n = 22) or paper diaries (n = 19) and followed for 6 months. About 86.2% (679 of 788) of infusions by patients in the computer group were in compliance with the data submission schedule compared with only 48.3% (358 of 741) of infusions by patients using paper diaries (P < 0.0001). The time intervals between infusions and the receipt of data were shorter in the computer group (median 0.25 vs. 25 days respectively, P < 0.0001). Reminder phone calls by the clinic were made less frequently to users of hand‐held computers than to users of paper diaries (median one vs. five times, P < 0.0001). Accuracy of data was similar for both methods. Compliance with hand‐held computers was superior to paper diaries. The clinic received data from hand‐held computers mostly on the same day, and nurses could thereby provide clinical advice more effectively. Although hand‐held computers did not result in increased accuracy, errors could be detected and corrected more rapidly. Electronic data can more easily be verified, analysed and summarized than that from paper diaries.

A multicenter pilot-randomized controlled trial of the feasibility of an augmented red blood cell transfusion strategy for patients treated with induction chemotherapy for acute leukemia or stem cell transplantation

BACKGROUND: Anemia may be an important factor contributing to an increased risk of bleeding, particularly in patients with thrombocytopenia.

Platelet transfusions in children: results of a randomized, prospective, crossover trial of plasma removal and a prospective audit of WBC reduction.

BACKGROUND : Febrile nonhemolytic transfusion reactions (FNHTRs) complicate 2 to 37 percent of platelet transfusions in adults, but the incidence of such reactions in children is not known. The effectiveness of plasma reduction after storage and WBC reduction of platelet concentrates before storage was studied in pediatric recipients of platelet transfusions.

In vivo recovery and survival of apheresis and whole blood‐derived platelets: a paired comparison in healthy volunteers

BACKGROUND: Methods of platelet preparation may alter the recovery and survival characteristics of platelets following transfusion. As suggested by a recent clinical trial, platelet recovery may be better preserved with apheresis platelet preparations than with platelets prepared from whole blood by the platelet‐rich plasma (PRP) method.

Misleading hepatitis B test results due to intravenous immunoglobulin administration: implications for a clinical trial of rituximab in immune thrombocytopenia

BACKGROUND: Rituximab may cause reactivation of hepatitis B virus (HBV) even in patients with remote HBV infection. Thus, the presence of hepatitis B core antibodies (anti‐HBc) was an exclusion criterion for a randomized trial of rituximab for patients with immune thrombocytopenia. A high seroprevalence of anti‐HBc observed among patients screened for the trial prompted this substudy to investigate for an association between anti‐HBc seropositivity and exposure to intravenous immunoglobulin (IVIG).

A new tool to assess bleeding severity in patients with chemotherapy-induced thrombocytopenia (CME)

BACKGROUND: Current scales to measure bleeding in clinical trials are inadequate. The aim of this study was to develop a simple, valid, and reliable measurement tool to categorize the severity of bleeding in patients with chemotherapy‐induced thrombocytopenia (CIT).

Developing a tracking system for coagulation factor concentrates in southern Ontario

BACKGROUND : In response to the transfusion‐ transmitted AIDS epidemic, Canadian authorities rec‐ ommended the development of tracking systems and improved reporting of adverse events. This study describes the development of a verifiable and comprehensive regional tracking system for coagulation factor concentrates.

Effect of a thrombopoietin receptor agonist on use of intravenous immune globulin in patients with immune thrombocytopenia

Thrombopoietin receptor agonists are new treatments for patients with chronic immune thrombocytopenia (ITP). How one of these agent, romiplostim, has impacted practice patterns, especially the use of intravenous immune globulin (IVIG), has not been evaluated outside of clinical trials.

Trends in the utilization and wastage of coagulation factor concentrates: the application of a regional tracking programme

Summary.  The Commission of Inquiry on the Blood System in Canada (‘Krever Commission’, 1997) recommended an active programme of surveillance for all blood products. To describe trends in the utilization of coagulation factor concentrates using a comprehensive factor tracking programme. Between 2001 and 2004 in the region of Southern Ontario, we prospectively tracked all coagulation factor concentrates that were distributed from the national blood supplier, issued by hospitals for inpatient use or for home infusions, infused at hospital facilities or at home and wasted. Discrepancies were reconciled by independent audits. Trends in the utilization of FVIII, FIX and FVIIa concentrates are reported. A total of 466 patients with inherited or acquired bleeding disorders were registered. Utilization of FVIII, FIX and FVIIa increased by an average of 13.7%, 33.2% and 34.2% per year respectively. Most FVIII and FIX infusions were administered at home while most FVIIa infusions were in hospital. The increase in FVIII and FIX usage was attributable to an increase in per‐patient use, predominantly for prophylaxis. In total, 1.7% of coagulation factor concentrates was wasted during the study period, at a cost of over 1 million Canadian dollars. Utilization of coagulation factor concentrates increased steadily during the study period. A regional programme to track utilization is feasible and may be used to describe trends, assist planning, and reduce costs by minimizing wastage.