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Biomedical subjects

Lawrence T Goodnough

Publications and source records attributed to Lawrence T Goodnough.

At least 19 recordsLinked to original sources
PubMed2006

Clinical benefits and risks associated with epoetin and darbepoetin in patients with chemotherapy-induced anemia: a systematic review of the literature.

BACKGROUND: Erythropoiesis-stimulating proteins (ESPs) are indicated for the treatment of chemotherapy-induced anemia (CIA). Evidence-based guidelines and systematic reviews of the management of CIA do not yet include all currently approved ESPs or all of the clinically relevant benefits and risks of ESPs. OBJECTIVES: The aims of this work were to provide up-to-date assessments of the clinical efficacy and effectiveness (ie, transfusions and quality-of-life [QoL] benefits) and safety (ie, risk of venous thromboembolism [VTE] and all-cause or treatment-associated death) of epoetin-alfa, epoetin-beta, and darbepoetin-alfa for the treatment of CIA in cancer patients with hemoglobin<11 g/dL. We also considered the impact of differences in study design, patients, and treatments on the results. METHODS: A systematic review of the literature was performed to identify and analyze English-language studies (controlled trials and prospective uncontrolled studies with >or=300 patients) published between 1980 and July 2005. The databases searched were MEDLINE and the Cochrane Library. Relevant abstracts from the last 2 annual meetings of the American Society of Clinical Oncology, American Society of Hematology, and European Society for Medical Oncology were also included. Studies were selected, using predefined eligibility criteria. Two reviewers had to agree on all included and excluded studies, and on all data extracted from each accepted study before they were entered into a relational database. Meta-analyses were performed to quantify benefit and risk outcomes. RESULTS: In total, 40 studies including 21,378 patients were eligible for analysis. Each ESP was found to have efficacy relative to standard care or placebo. The odds ratio (OR) for transfusions in studies of epoetin versus controls was 0.44 (95% CI, 0.35-0.55) and of darbepoetin versus controls was 0.41 (95% CI, 0.31-0.55). Patients receiving ESPs experienced a significant improvement in QoL; the mean difference in Functional Assessment of Cancer Therapy-Fatigue score for ESPs versus controls was 0.23 (95% CI, 0.10-0.36; P=0.001). The frequency of VTE and death was not significantly different between ESPs and control (VTE OR, 1.41 [95% CI, 0.81-2.47]; all-cause mortality OR, 1.00 [95% CI, 0.69-1.44]). CONCLUSIONS: This analysis of key clinical benefits and risks of epoetin and darbepoetin in the treatment of CIA found no clinically relevant differences between these drugs.

Adult↗
PubMed2006

Objectives and limitations of bloodless medical care.

PURPOSE OF REVIEW: To outline the rationale, limitations, and execution of bloodless medical and surgical programs, highlighting characteristics that contribute to successful outcomes. RECENT FINDINGS: Clinical experiences with patients who refuse blood transfusions for religious reasons have provided valuable lessons and raise intriguing questions about the necessity of routine blood transfusions. Healthcare centers with bloodless medicine and surgery programs feature a novel concept of patient care aimed at improving outcomes. A one-tiered approach to minimize blood usage for all patients, regardless of religious beliefs, is being successfully adopted at an increasing number of institutions. Since most single blood-conservation techniques reduce blood usage by just 1-2 units, a series of integrated preoperative, intraoperative, and postoperative conservation approaches is required. These include preoperative autologous donation, erythropoietic support, acute normovolemic hemodilution, individualized assessment of anemia tolerance, implementation of conservative transfusion thresholds, meticulous surgical techniques, and judicious use of phlebotomy and pharmacologic agents for limiting blood loss. SUMMARY: The objectives of bloodless medicine and surgery programs are straightforward but require staff with expertise in transfusion medicine, intensive teamwork, patient-specific customization, careful planning, and integrated use of multimodal strategies.

Blood Loss, Surgical↗
PubMed2006

A randomized, controlled Phase III trial of therapeutic plasma exchange with fresh-frozen plasma (FFP) prepared with amotosalen and ultraviolet A light compared to untreated FFP in thrombotic thrombocytopenic purpura.

BACKGROUND: Photochemical treatment of fresh-frozen plasma (FFP) with amotosalen and ultraviolet (UV) A light (PCT FFP) results in inactivation of a broad spectrum of pathogens while retaining coagulation factor activity, antithrombotic proteins, and von Willebrand factor-cleaving protease (VWF-CP) activity. STUDY DESIGN AND METHODS: A randomized, controlled, double-blind Phase III trial was conducted with PCT FFP or control FFP for therapeutic plasma exchange (TPE) in patients with thrombotic thrombocytopenic purpura (TTP). Owing to the rarity of this diagnosis, the trial was not powered to demonstrate small differences between treatment groups. Patients were treated with study FFP for a maximum of 35 days until remission was achieved (for a maximum of 30 daily study TPEs with no remission) plus an additional 5 days after remission. RESULTS: Among the 35 patients treated, the primary endpoint, remission within 30 days, was achieved by 14 of 17 (82%) PCT patients and 16 of 18 (89%) control patients (p = 0.658) The 90 percent confidence interval for treatment difference in remission rate for test - control was (-0.291 to 0.163). Time to remission, relapse rates, time to relapse, total volume and number of FFP units exchanged, and number of study TPEs were not significantly different between groups. Improvement in VWF-CP and inhibitors was similar for both groups. The overall safety profile of PCT FFP was similar to control FFP. No antibodies to amotosalen neoantigens were detected. CONCLUSION: The comparable results between treatment groups observed from this small trial suggest that TPE with PCT FFP was safe and effective for treatment of TTP.

Adolescent↗
PubMed2005

Autologous blood donation.

Preoperative autologous blood donation has become accepted as a standard practice in elective surgery. Subsequent improvements in blood safety and evolving surgical techniques resulting in less blood loss have caused a national decline in preoperative autologous blood donation by approximately 50%. Nevertheless, the continuing emergence of new pathogens and the potential for severe blood inventory shortages continue to give preoperative autologous blood donation an important role in blood conservation strategies.

Blood Donors↗
PubMed2005

Risks of blood transfusion.

This article discusses advances in blood safety during the last 20 years, particularly for prevention of transfusion-transmitted viral infections. Although the most serious known risks from blood transfusion are administrative errors, transfusion-related acute lung injury, and bacterial contamination in platelet products, infection from emerging pathogens such as West Nile virus emphasizes the need for implementing proactive strategies. Pathogen inactivation technologies and reactive strategies such as nucleic acid testing ensure continued advances in blood safety.

Bacterial Infections↗
PubMed2005

Detection, evaluation, and management of anemia in the elective surgical patient.

The prevalence of anemia in elective surgical patients may be as frequent as 75% in certain populations. A national audit demonstrated that 35% of patients scheduled for joint replacement therapy have a hemoglobin <13 g/dL on preadmission testing. Standard practice currently consists of preadmission testing 3 to 7 days before an elective operative procedure, precluding the opportunity to effectively evaluate and manage a patient with unexpected anemia. Therefore, a standardized approach for the detection, evaluation, and management of anemia in the preoperative surgical setting was identified as an unmet medical need. To address this knowledge gap, we convened a panel of physicians to develop a clinical care pathway for anemia management in this setting. Elective surgery patients should receive a hemoglobin (Hgb) determination a minimum of 30 days before the scheduled surgical procedure. Because the identification and evaluation of anemia in this setting will assist in expedited diagnosis and treatment of underlying comorbidities and will improve patient outcomes, unexplained anemia (Hgb <12 g/dL for females and <13 g/dL for males) should cause elective surgery to be deferred until an evaluation can be performed.

Anemia↗
PubMed2004

Effects of pretransplantation treatment with rituximab on outcomes of autologous stem-cell transplantation for non-Hodgkin's lymphoma.

PURPOSE: To analyze the effects of preautografting treatment with rituximab (R) on stem-cell mobilization, post-transplantation complications, engraftment, disease-free survival, and overall survival in patients with non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS: Single-institution retrospective comparative outcome analysis in a cohort of 273 relapsed chemosensitive NHL patients of whom 127 (47%) received R pretransplantation. RESULTS: R was administered a median of 3 months before autologous transplantation. When compared to the nonrituximab group, R patients were older (56 v 50 years; P < .001), and had delays in post-transplantation platelets recovery (39 v 27 days; P = .001). Pretransplantation R did not affect stem-cell mobilization, post-transplantation early complications, duration of hospitalization, or mortality rates at days 30 and 100. In contrast to patients with low-grade NHL, both disease-free and overall survival rates were significantly better when R was included in the pretransplantation salvage therapy for patients with intermediate-grade NHL. CONCLUSION: In this large, single-center retrospective analysis, pretransplantation treatment with R was associated with improved survival in patients with intermediate-grade NHL, at the price, however, of a delay in platelet engraftment.

Adult↗
PubMed2004

Autologous blood donation.

Although preoperative autologous blood donation is employed in elective surgery, this is declining because of the increasingly safe allogeneic blood supply. However, it continues to be used because of the public's perception of allogeneic blood risks and increasing blood shortages. Patients may donate a unit of blood (450 +/- 45 ml) as often as twice weekly, up to 72 hours before surgery. Preoperative autologous blood is most beneficial in procedures that cause significant blood loss. It has been determined that preoperative autologous blood donation is poorly cost-effective; the use of this procedure must be based on evidence that it is safe and of value for the patient.

Blood Transfusion, Autologous↗
PubMed2004

Therapeutic efficacy and safety of platelets treated with a photochemical process for pathogen inactivation: the SPRINT Trial.

We report a transfusion trial of platelets photochemically treated for pathogen inactivation using the synthetic psoralen amotosalen HCl. Patients with thrombocytopenia were randomly assigned to receive either photochemically treated (PCT) or conventional (control) platelets for up to 28 days. The primary end point was the proportion of patients with World Health Organization (WHO) grade 2 bleeding during the period of platelet support. A total of 645 patients (318 PCT and 327 control) were evaluated. The primary end point, the incidence of grade 2 bleeding (58.5% PCT versus 57.5% control), and the secondary end point, the incidence of grade 3 or 4 bleeding (4.1% PCT versus 6.1% control), were equivalent between the 2 groups (P =.001 by noninferiority). The mean 1-hour posttransfusion platelet corrected count increment (CCI) (11.1 x 10(3) PCT versus 16.0 x 10(3) control), average number of days to next platelet transfusion (1.9 PCT versus 2.4 control), and number of platelet transfusions (8.4 PCT versus 6.2 control) were different (P <.001). Transfusion reactions were fewer following PCT platelets (3.0% PCT versus 4.4% control; P =.02). The incidence of grade 2 bleeding was equivalent for PCT and conventional platelets, although posttransfusion platelet count increments and days to next transfusion were decreased for PCT compared with conventional platelets.

Adolescent↗
PubMed2004

Effect of plasma exchange on plasma ADAMTS13 metalloprotease activity, inhibitor level, and clinical outcome in patients with idiopathic and nonidiopathic thrombotic thrombocytopenic purpura.

Therapeutic plasma exchange is an effective empiric treatment for thrombotic thrombocytopenic purpura (TTP), but how therapy affects the level of a disintegrin and metalloprotease with thrombospondin type 1 motif 13 (ADAMTS13) or inhibitor has not been reported in many patients. We prospectively analyzed ADAMTS13 activity and inhibitor levels in 37 adults with TTP. ADAMTS13 level at presentation was lower than 5% in 16 of 20 patients with idiopathic TTP and in none of 17 patients with TTP associated with hematopoietic stem cell transplantation, cancer, drugs, or pregnancy (P <.00001). Seven of the 16 patients with ADAMTS13 activity lower than 5% ( approximately 44%) had inhibitors. For 8 patients followed serially with ADAMTS13 activity lower than 5% but no inhibitor at presentation, plasma exchange led to complete clinical remission and a rise in ADAMTS13 level. In contrast, 4 patients with low ADAMTS13 activity but high-titer inhibitor (> 5 units/mL) had neither a rise in ADAMTS13 activity nor a reduction in the inhibitor titer: 3 had recurrent disease and 1 died. Among 17 patients with AD-AMTS13 activity at presentation higher than 25%, 10 died. Mortality rate for idiopathic TTP was 15%, whereas mortality for nonidiopathic TTP was 59% (P <.02). We conclude that assays of ADAMTS13 activity and inhibitors in addition to the clinical categories (idiopathic TTP and nonidiopathic TTP) are predictive of outcome and may be useful to tailor patient treatment.

ADAM Proteins↗
PubMed2004

Autoantibody formation after alloimmunization: are blood transfusions a risk factor for autoimmune hemolytic anemia?

BACKGROUND: The development of RBC autoantibodies resulting from or associated with allogeneic blood transfusions (i.e., RBC autoimmunization) is not a well-recognized complication of RBC transfusions. STUDY DESIGN AND METHODS: T: he presentation, laboratory evaluation, clinical course, and management of two patients whose autoimmune hemolytic anemia followed allogeneic blood transfusion and occurred in association with the development of one or more alloantibodies is described. A retrospective analysis was performed of our blood-bank records over 1 year to determine the frequency of RBC autoimmunization associated with alloimmunization. RESULTS: Out of 2618 patients who had a positive DAT or IAT, 121 were identified with RBC autoantibodies; 41 of these patients had both allo- and autoantibodies to RBC antigens, whereas the remainder, 80, had only autoantibodies. At least 34 percent (12/41) of these patients (none with hemoglobinopathy) developed their autoantibodies in temporal association with alloimmunization after recent blood transfusion(s). CONCLUSION: RBC autoimmunization and the development of autoimmune hemolytic anemia should be recognized as a complication of allogeneic blood transfusion. The need for additional blood transfusion was successfully avoided in one patient by treatment with recombinant human EPO and corticosteroid therapy. Once RBC autoimmunization is identified, subsequent management should incorporate a strategy that minimizes subsequent exposure to allogeneic blood.

Adult↗
PubMed2004

Joint ASH and AABB educational session.

In the vein-to-vein flow of blood from donor to patient, the role of the transfusion medicine specialist has become increasingly centered at the bedside. Three clinically centered issues in blood safety and in blood conservation are presented in this chapter. In Section I, Dr. Patricia Hewitt presents the epidemiologic and clinical evidence regarding new variant Creutzfeldt-Jakob disease (nvCJD) in the UK and its relevance to transfusion medicine. Lessons learned from the responses by the National Blood Service to this crisis are discussed, particularly in the context of recent evidence of a case of vCJD transmission by blood transfusion and a second case of apparent transmission of abnormal prion protein without development of clinical illness. In Section II, Dr. Christopher Silliman and his colleagues summarize recent knowledge gained regarding transfusion-related acute lung injury (TRALI), which is now the leading cause of transfusion-related mortality. Two different etiologies have been proposed: a single antibody-medicated event, involving anti-HLA Class I and Class II, or anti-granulocyte antibodies; and a two-event model, which includes the clinical condition of the patient resulting in pulmonary endothelial activation and neutrophil sequestration. The second event is the transfusion of a biologic response modifier (lipids or antibodies) in the blood component that activates primed neutrophils. Prevention, clinical treatment, and proposed definition of TRALI are discussed. In Section III, Dr. Lawrence Goodnough and colleagues present a transfusion medicine service approach to the utilization of recombinant factor VIIa (rFVIIa) in non-approved clinical settings. rFVIIa has a potential role as a hemostatic intervention in a variety of clinical settings, yet few clinical trials have been completed to date to guide indications for its use. The policies presented here are those in place at the authors' medical center, and will undergo periodic review and revision as relevant new information and data are generated.

Blood Transfusion↗
PubMed2003

Remission of chronic thrombotic thrombocytopenic purpura after treatment with cyclophosphamide and rituximab.

BACKGROUND: Thrombotic thrombocytopenic purpura (TTP) in adults is usually caused by autoantibody inhibitors of ADAMTS13. Treatment with plasma exchange is often effective but does not address the underlying autoimmune process. OBJECTIVE: To report the efficacy of intensive immunosuppressive therapy in refractory TTP. DESIGN: Case report. SETTING: University medical center. PATIENT: 42-year-old woman with chronic relapsing TTP. INTERVENTION: Immunosuppression therapy with rituximab and cyclophosphamide. MEASUREMENTS: ADAMTS13 activity and inhibitors and hematologic variables for TTP. RESULTS: For 19 months, the patient had relapsing thrombotic microangiopathy despite plasma exchange; splenectomy; and therapy with vincristine, prednisone, and cyclosporine. ADAMTS13 activity was low, and tests detected an IgG inhibitor that recognized the metalloprotease domain of recombinant ADAMTS13. After treatment with rituximab and cyclophosphamide, the disease remitted, ADAMTS13 levels normalized, and the inhibitor was undetectable. The patient has required no treatment for 13 months. CONCLUSION: Intensive immunosuppressive therapy can lead to sustained clinical remission in patients with refractory autoimmune TTP.

ADAM Proteins↗
PubMed2003

Transfusion medicine: looking to the future.

The evolution of transfusion medicine into a clinically oriented discipline emphasising patient care has been accompanied by challenges that need to be faced as specialists look to the future. Emerging issues that affect blood safety and blood supply, such as pathogen inactivation and more stringent donor screening questions, bring new pressures on the availability of an affordable blood supply. Imminent alternatives for management of anaemia, such as oxygen carriers, hold great promise but, if available, will require close oversight. With current estimates of HIV or hepatitis C viral (HCV) transmission approaching one in 2000000 units transfused, keeping to a minimum bacterial contamination of platelet products (one in 2000) and errors in transfusion, with its estimated one in 800000 mortality rate, assume great urgency. Finally, serious difficulties in blood safety and availability for poor, developing countries require innovative strategies and commitment of resources.

Blood Banks↗