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  • American Society of Hematology  (6)
  • 1
    Online Resource
    Online Resource
    Making Decisions about Thromboprophylaxis in Pregnancy: Women's Values and Preferences
    American Society of Hematology ; 2014
    In:  Blood Vol. 124, No. 21 ( 2014-12-06), p. 4833-4833
    Details
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 4833-4833
    Abstract: Background: The risk of pregnancy-related venous thromboembolism (VTE) is increased in women with a history of thrombosis. Although antepartum low molecular weight heparin (LMWH) prophylaxis can reduce this risk; the baseline risk of recurrence and the absolute magnitude of the risk reduction with prophylaxis are uncertain. Further, LMWH prophylaxis is costly, burdensome, medicalizes pregnancy, and may increase the risk of bleeding. Therefore, uncertainty persists regarding the net benefit of thromboprophylaxis and recommendations about the use of antepartum LMWH should be sensitive to pregnant women’s values and preferences, which have not previously been studied. Methods: We undertook an international multicenter cross-sectional interview study that included women with a history of VTE who were pregnant, planning pregnancy, or might consider pregnancy in the future. Women were classified as high (5 to 10%) or low (1 to 5%) risk of recurrent antepartum VTE. We ascertained willingness to receive LMWH during pregnancy through direct choice exercises involving real-life scenarios using the participant’s estimated VTE (high or low) and bleeding risks, hypothetical scenarios (low, medium and high risk of recurrence) and a probability trade-off exercise. Study outcomes included the minimum absolute reduction in VTE risk at which women changed from declining to accepting LMWH, along with possible determinants of this threshold, and participant choice of management strategy in her real-life and the three hypothetical scenarios. Results: 123 women from seven centers in six countries participated. Using a fixed 16% VTE risk without prophylaxis, the mean threshold reduction in risk at which women were willing to use LMWH was 4.3% (95% CI, 3.5 – 5.1%). Pregnant women and those planning a pregnancy (compared to those who might consider pregnancy in the future) and those with less than 2 weeks of experience with using LMWH during pregnancy (compared to those with more experience) required a greater risk reduction to use prophylaxis. In the real life scenario, there was there a significant difference in the proportion of women choosing prophylaxis between those at high risk (87.1%) and low risk (60.0%) of recurrence (p=0.01). The proportion of women choosing to use LMWH prophylaxis was 65.1% for the low risk hypothetical scenario (4% risk of recurrence), 79.7% for the medium risk scenario (10% risk of recurrence) and 87.8% for the high risk scenario (16% risk of recurrence). Conclusions: Most women with prior VTE will choose prophylaxis during a subsequent pregnancy, regardless of whether they are categorized as high or low risk of recurrence. Nevertheless, 40% of lower risk women will decline LMWH, as will over 10% of high risk women. Thus, these results mandate individualized clinical decision-making for women considering LMWH use during pregnancy, and weak guideline recommendations for LMWH use that highlight the need for individualized decision-making. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V124.21.4833.4833
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
    detail.hit.zdb_id: 1468538-3
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  • 2
    Online Resource
    Online Resource
    Transfusion of fresher vs older red blood cells in hospitalized patients: a systematic review and meta-analysis
    American Society of Hematology ; 2016
    In:  Blood Vol. 127, No. 4 ( 2016-01-28), p. 400-410
    Details
    In: Blood, American Society of Hematology, Vol. 127, No. 4 ( 2016-01-28), p. 400-410
    Abstract: The impact of transfusing fresher vs older red blood cells (RBCs) on patient-important outcomes remains controversial. Two recently published large trials have provided new evidence. We summarized results of randomized trials evaluating the impact of the age of transfused RBCs. We searched MEDLINE, EMBASE, CINAHL, the Cochrane Database for Systematic Reviews, and Cochrane CENTRAL for randomized controlled trials enrolling patients who were transfused fresher vs older RBCs and reported outcomes of death, adverse events, and infection. Independently and in duplicate, reviewers determined eligibility, risk of bias, and abstracted data. We conducted random effects meta-analyses and rated certainty (quality or confidence) of evidence using the GRADE approach. Of 12 trials that enrolled 5229 participants, 6 compared fresher RBCs with older RBCs and 6 compared fresher RBCs with current standard practice. There was little or no impact of fresher vs older RBCs on mortality (relative risk [RR] , 1.04; 95% confidence interval [CI], 0.94-1.14; P = .45; I2 = 0%, moderate certainty evidence) or on adverse events (RR, 1.02; 95% CI, 0.91-1.14; P = .74; I2 = 0%, low certainty evidence). Fresher RBCs appeared to increase the risk of nosocomial infection (RR, 1.09; 95% CI, 1.00-1.18; P = .04; I2 = 0%, risk difference 4.3%, low certainty evidence). Current evidence provides moderate certainty that use of fresher RBCs does not influence mortality, and low certainty that it does not influence adverse events but could possibly increase infection rates. The existing evidence provides no support for changing practices toward fresher RBC transfusion.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2015-09-670950
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 3
    Online Resource
    Online Resource
    An Individual Participant Data Meta-Analysis of 13 Randomized Trials to Evaluate the Impact of Prophylactic Use of Heparin in Oncological Patients
    American Society of Hematology ; 2017
    In:  Blood Vol. 130, No. Suppl_1 ( 2017-12-07), p. 626-626
    Details
    In: Blood, American Society of Hematology, Vol. 130, No. Suppl_1 ( 2017-12-07), p. 626-626
    Abstract: Background: Parenteral anticoagulants may improve outcomes in patients with cancer by reducing the risk of venous thromboembolism (VTE) and through a direct anti-tumour effect. Study-level meta-analysis indicates a reduction in VTE and provide moderate certainty that a small survival benefit exists; it is unclear if patients with specific cancers benefit more or less. Utilizing data from randomized controlled trials (RCT), this individual participant data meta-analysis examines the impact of heparin on survival, VTE and major bleeding in oncological patients randomized to low-molecular weight heparin (LMWH) or no LMWH. Methods: We performed a comprehensive systematic search for all RCTS (last search date March 2017) and contacted authors and sponsors to obtain individual participant data of patients with solid cancers and no other indication for prophylactic or therapeutic anticoagulation. We utilized the GRADE approach to evaluate the certainty of evidence and produce an evidence profile. All analyses followed the intention-to-treat principle. We calculated the impact on mortality through multivariable hierarchical models with patient-level variables as fixed effects and a categorical trial variable as a random effect. We adjusted the analysis for age, cancer type and metastasis status. To investigate whether intervention effects vary by predefined subgroups, including type of cancer, we tested interaction terms in the statistical model. Results: A total of 18 RCTs (n=10,041 participants) were eligible for inclusion and we obtained data from 82.4% of the participants (13 RCTs, n=8,278; n=4,139 for LMWH and n=4,139 for no LMWH). The meta-analysis revealed an adjusted relative risk of mortality within one year of 0.99 (95% CI: 0.95, 1.03) and a hazard ratio of 0.97 (95% CI: 0.82, 1.14) after one year. The relative risk for VTE was 0.58 (95% CI: 0.48, 0.71), 0.57 (95% CI: 0.44, 0.74) for symptomatic deep vein thrombosis and 0.58 (95%CI: 0.44, 0.77) for symptomatic pulmonary embolism, separately. For every 1,000 patients treated, approximately 16 fewer would experience symptomatic DVT and 16 fewer would experience any PE. The adjusted relative risk for major bleeding throughout trial duration was 1.24 (95% CI: 0.91, 1.69; P=0.17). Subgroup analysis, by cancer type, of VTE occurrence throughout trial duration identified lung cancer OR=0.52 (95% CI: 0.39, 0.68; P & lt;0.001) and pancreatic cancer OR=0.55 (95% CI: 0.35, 0.88; P=0.01) patients as experiencing the greatest benefit from LMWH treatment. The certainty of the evidence for the outcomes was moderate to high. Conclusion: LMWH reduces risk of VTE without increasing risk of bleeding but does not improve survival across all patients. Funding: Canadian Institutes of Health Research knowledge synthesis grant, KRS 126594 Registration: International Prospective Register for Systematic Reviews (PROSPERO), CRD42013003526. Disclosures Schünemann: Canadian Institutes of Health Research: Research Funding. Crowther: Alexion: Speakers Bureau; Bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Boehringer Ingelheim: Speakers Bureau; Leo Pharma: Research Funding; Pfizer: Honoraria; Portola: Consultancy; Shinogi: Consultancy. Macbeth: Pfizer: Other: Provision of Dalteparin for FRAGMATIC trial; Cancer Research UK: Research Funding. Griffiths: Pfizer: Consultancy, Other: Comment: I run an academic clinical trials unit, have received educational/investigator intiated research grants from companies that make these heparin agents. As consultant & gt; 3 years ago, advised Pfizer on clinical trial designs unrelated to this study., Research Funding. Van Es: Pfizer: Employment, Other: Comment: Dr. van Es reports personal fees from Pfizer as a member of their advisory board. These fees are unrelated to this project.. Streiff: Roche: Research Funding; Portola: Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Research Funding; CSL Behring: Consultancy, Research Funding. Ageno: BMS-Pfizer: Consultancy, Honoraria; Bayer AG: Consultancy, Honoraria, Research Funding; Boehringer Ingelheim: Consultancy, Honoraria; Daiichi Sankyo: Consultancy, Honoraria. Bozas: PharmaMar: Honoraria. McBane: Bristol Myers Squibb: Other: Research grant for cancer associated VTE. Maraveyas: Bayer: Other: Personal fees and conference attendance; Bristol-Myers Squibb: Other: Grants and personal fees; Leo Pharma: Other: Grants, personal fees and conference attendance; Pfizer: Other: Personal fees. Loprinzi: Bristol Myers: Other: Grant - unrelated to this project; Janssen: Other: Grant - unrelated to this project.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V130.Suppl_1.626.626
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2017
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 4
    Online Resource
    Online Resource
    The Khorana Score for the Prediction of Venous Thromboembolism in Patients with Solid Cancer: An Individual Patient Data Meta-Analysis
    American Society of Hematology ; 2017
    In:  Blood Vol. 130, No. Suppl_1 ( 2017-12-07), p. 627-627
    Details
    In: Blood, American Society of Hematology, Vol. 130, No. Suppl_1 ( 2017-12-07), p. 627-627
    Abstract: Background: Guidelines suggest the use of the Khorana score to select patients with solid cancer receiving chemotherapy for thromboprophylaxis to prevent venous thromboembolism (VTE), but its performance in different types of cancers remains uncertain. Methods: The present analysis includes individual patient data from seven randomized controlled trials that had compared prophylactic (ultra)-low-molecular-weight heparin (LMWH) with placebo or observation in patients with solid cancer. The analysis addresses the performance of the continuous and dichotomized Khorana score in predicting the 6-month risk of VTE in the trial control groups, overall and in types of cancer studies, as well as the efficacy and safety of LMWH among patients with a high-risk Khorana score. Random effects meta-analysis provided the basis for summary estimates. Findings: In the 3,403 patients from the control groups included in the analyses, the mean age was 61 years, 59% were male, and 58% had lung cancer. During 6-months of follow-up, 188 patients (5.5%) developed VTE. Overall, the 6-month VTE incidence was 9.8% among high-risk Khorana score patients and 6.4% among low-to-intermediate risk patients (OR 1.6; 95%-CI 1.1-2.2). The dichotomous Khorana score performed differently in lung cancer patients (OR 1.1; 95%-CI, 0.72-1.7) than in those with other types of cancer (OR 4.4; 95%-CI, 2.7-7.3; P interaction=0.002). Among high-risk patients, LMWH decreased the risk of VTE by 64% compared to placebo or observation (OR 0.36; 95%-CI, 0.22-0.58). In the group of patients with types of cancer other than lung cancer and a high-risk Khorana score (N=619), the 6-month VTE incidence was 3.3% (95% CI, 1.4 to 7.7) among LMWH recipients and 13% (95% CI, 6.8 to 24) among those not receiving LMWH (OR 0.23, 95% CI, 0.11 to 0.46; P & lt;0.001). There was no difference in major bleeding (OR 1.2, 95% CI, 0.56 to 2.5). Interpretation: The Khorana score performs poorly in differentiating between those at high and low risk of VTE in patients with lung cancer, but is associated with a 4-fold increased risk of VTE in those with other types of cancer. Thromboprophylaxis is effective and safe in patients with a high-risk Khorana score. Funding: Canadian Institutes of Health Research knowledge synthesis grant, KRS 126594 Registration: International Prospective Register for Systematic Reviews (PROSPERO), CRD42013003526. Disclosures Van Es: Pfizer: Employment, Other: Comment: Dr. van Es reports personal fees from Pfizer as a member of their advisory board. These fees are unrelated to this project.. Crowther: Alexion: Speakers Bureau; Bayer: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Boehringer Ingelheim: Speakers Bureau; Leo Pharma: Research Funding; Pfizer: Honoraria; Portola: Consultancy; Shinogi: Consultancy. Macbeth: Cancer Research UK: Research Funding; Pfizer: Other: Provision of Dalteparin for FRAGMATIC trial. Griffiths: Pfizer: Consultancy, Other: Comment: I run an academic clinical trials unit, have received educational/investigator intiated research grants from companies that make these heparin agents. As consultant & gt; 3 years ago, advised Pfizer on clinical trial designs unrelated to this study., Research Funding. Streiff: Roche: Research Funding; Portola: Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Research Funding; CSL Behring: Consultancy, Research Funding. Ageno: Daiichi Sankyo: Consultancy, Honoraria; Bayer AG: Consultancy, Honoraria, Research Funding; BMS-Pfizer: Consultancy, Honoraria; Boehringer Ingelheim: Consultancy, Honoraria. Bozas: PharmaMar: Honoraria. Maraveyas: Bayer: Other: Personal fees and conference attendance; Bristol-Myers Squibb: Other: Grants and personal fees; Leo Pharma: Other: Grants, personal fees and conference attendance; Pfizer: Other: Personal fees. Loprinzi: Bristol Myers: Other: Grant - unrelated to this project; Janssen: Other: Grant - unrelated to this project. McBane: Bristol Myers Squibb: Other: Research grant for cancer associated VTE. Schünemann: Canadian Institutes of Health Research: Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V130.Suppl_1.627.627
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2017
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 5
    Online Resource
    Online Resource
    Methodology for the American Society of Hematology VTE guidelines: current best practice, innovations, and experiences
    American Society of Hematology ; 2020
    In:  Blood Advances Vol. 4, No. 10 ( 2020-05-26), p. 2351-2365
    Details
    In: Blood Advances, American Society of Hematology, Vol. 4, No. 10 ( 2020-05-26), p. 2351-2365
    Abstract: Methods for the development of clinical guidelines have advanced dramatically over the past 2 decades to strive for trustworthiness, transparency, user-friendliness, and rigor. The American Society of Hematology (ASH) guidelines on venous thromboembolism (VTE) have followed these advances, together with application of methodological innovations. Objective: In this article, we describe methods and methodological innovations as a model to inform future guideline enterprises by ASH and others to achieve guideline standards. Methodological innovations introduced in the development of the guidelines aim to address current challenges in guideline development. Methods: We followed ASH policy for guideline development, which is based on the Guideline International Network (GIN)-McMaster Guideline Development Checklist and current best practices. Central coordination, specialist working groups, and expert panels were established for the development of 10 VTE guidelines. Methodological guidance resources were developed to guide the process across guidelines panels. A methods advisory group guided the development and implementation of methodological innovations to address emerging challenges and needs. Results: The complete set of VTE guidelines will include & gt;250 recommendations. Methodological innovations include the use of health-outcome descriptors, online voting with guideline development software, modeling of pathways for diagnostic questions, application of expert evidence, and a template manuscript for publication of ASH guidelines. These methods advance guideline development standards and have already informed other ASH guideline projects. Conclusions: The development of the ASH VTE guidelines followed rigorous methods and introduced methodological innovations during guideline development, striving for the highest possible level of trustworthiness, transparency, user-friendliness, and rigor.
    Type of Medium: Online Resource
    ISSN: 2473-9529 , 2473-9537
    URL: Article
    DOI: 10.1182/bloodadvances.2020001768
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2020
    detail.hit.zdb_id: 2876449-3
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  • 6
    Online Resource
    Online Resource
    Impact of the Intensity of Conditioning Therapy On the Outcomes of Patients Aged 40 to 60 Years with Acute Myeloid Leukemia/Myelodysplastic Syndrome Undergoing Allogeneic Hematopoietic Cell Transplantation.
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 22 ( 2009-11-20), p. 1202-1202
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 1202-1202
    Abstract: Abstract 1202 Poster Board I-224 Introduction: The eligibility of patients to undergo allogeneic hematopoietic cell transplantation (AHCT) is limited by age, co-morbid conditions and performance status. Utilizing reduced and minimal intensity conditioning regimens, older and less fit patients could benefit from this modality with the graft versus leukemia effect. Methods: We performed a retrospective analysis of adults aged 40-60 years with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) undergoing AHCT at our center from January 2002 to June 2008. The objective of the study is to compare the overall (OS), relapse free (RFS), acute GvHD free and chronic GvHD free survival between the different conditioning regimens. The regimens are classified according to the definition of CIBMTR as conventional intensity (CIC) or reduced intensity (RIC). High risk disease is defined as patients meeting one of the following criteria: AML with poor risk cytogenetics, secondary AML with preceding hematologic disorder, AML in second complete remission or AML/MDS with preceding malignancy. Results: There are 106 patients eligible for the study (CIC 67, RIC 39); 56 patients with de novo AML, 22 with MDS and 28 with secondary AML. High risk disease comprised 64% of our study population. The baseline characteristics between the two groups including performance status (Karnofsky Performance Score; CIC 81%, RIC 83%, p=0.08) are not different except for age (mean in years; CIC 50.2, RIC 52.9, p=0.03), graft versus host disease (GvHD) prophylaxis (cyclosporine/alemtuzumab; CIC 16%, RIC 57%, p 〈 0.001), donor type (unrelated donor; CIC 30%, RIC 54%, p=0.04) and Seattle co-morbidity index score (score of ≥3; CIC 12%, RIC 31%, p=0.03). The median follow up duration for all patients was 1.93 years. There is no statistically significant difference in the OS between the two groups (median OS in years; CIC 1.93, RIC 2.59, Log-rank p=0.62). Furthermore, RFS between the two groups were similar (median RFS was not reached in either groups, Log-rank p=0.86). Using Cox-model adjusting for important prognostic factors at baseline (age, disease risk, donor type, performance status, Co-morbidity index score and type of conditioning regimen), only performance status and disease risk are significant for both OS (HR 0.906 [p=0.01] and 2.13 [p=0.04] respectively) and RFS (HR 0.854 [p=0.04] and 6.931 [p=0.007] respectively). The acute GvHD and chronic GvHD free survival curves are not significantly different in the two groups (Log-rank p values are 0.66 and 0.16 respectively). Conclusion: Despite inferior baseline characteristics in the patients receiving RIC, the outcomes were similar. Disease biology rather than intensity of the conditioning therapy is the determinant of overall survival and relapse risk after AHCT in patients aged 40-60 years with AML/MDS. Prospective randomized studies are needed to determine the superiority of RIC in patients who are deemed suitable to undergo CIC. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V114.22.1202.1202
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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