Abstract:
BACKGROUND:Effective treatment of trauma-induced coagulopathy is important; however, the optimal therapy is still not known. We aimed to compare the efficacy of first-line therapy using fresh frozen plasma (FFP) or coagulation factor concentrates (CFC) for the reversal of trauma-induced coagulopathy, the arising transfusion requirements, and consequently the development of multiple organ failure. METHODS:This single-centre, parallel-group, open-label, randomised trial was done at the Level 1 Trauma Center in Innsbruck Medical University Hospital (Innsbruck, Austria). Patients with trauma aged 18-80 years, with an Injury Severity Score (ISS) greater than 15, bleeding signs, and plasmatic coagulopathy identified by abnormal fibrin polymerisation or prolonged coagulation time using rotational thromboelastometry (ROTEM) were eligible. Patients with injuries that were judged incompatible with survival, cardiopulmonary resuscitation on the scene, isolated brain injury, burn injury, avalanche injury, or prehospital coagulation therapy other than tranexamic acid were excluded. We used a computer-generated randomisation list, stratification for brain injury and ISS, and closed opaque envelopes to randomly allocate patients to treatment with FFP (15 mL/kg of bodyweight) or CFC (primarily fibrinogen concentrate [50 mg/kg of bodyweight]). Bleeding management began immediately after randomisation and continued until 24 h after admission to the intensive care unit. The primary clinical endpoint was multiple organ failure in the modified intention-to-treat population (excluding patients who discontinued treatment). Reversal of coagulopathy and need for massive transfusions were important secondary efficacy endpoints that were the reason for deciding the continuation or termination of the trial. This trial is registered with ClinicalTrials.gov, number NCT01545635. FINDINGS:Between March 3, 2012, and Feb 20, 2016, 100 out of 292 screened patients were included and randomly allocated to FFP (n=48) and CFC (n=52). Six patients (four in the FFP group and two in the CFC group) discontinued treatment because of overlooked exclusion criteria or a major protocol deviation with loss of follow-up. 44 patients in the FFP group and 50 patients in the CFC group were included in the final interim analysis. The study was terminated early for futility and safety reasons because of the high proportion of patients in the FFP group who required rescue therapy compared with those in the CFC group (23 [52%] in the FFP group vs two [4%] in the CFC group; odds ratio [OR] 25·34 [95% CI 5·47-240·03], p<0·0001) and increased needed for massive transfusion (13 [30%] in the FFP group vs six [12%] in the CFC group; OR 3·04 [0·95-10·87], p=0·042) in the FFP group. Multiple organ failure occurred in 29 (66%) patients in the FFP group and in 25 (50%) patients in the CFC group (OR 1·92 [95% CI 0·78-4·86], p=0·15). INTERPRETATION:Our results underline the importance of early and effective fibrinogen supplementation for severe clotting failure in multiple trauma. The available sample size in our study appears sufficient to make some conclusions that first-line CFC is superior to FFP. FUNDING:None.
journal_name
Lancet Haematoljournal_title
The Lancet. Haematologyauthors
Innerhofer P,Fries D,Mittermayr M,Innerhofer N,von Langen D,Hell T,Gruber G,Schmid S,Friesenecker B,Lorenz IH,Ströhle M,Rastner V,Trübsbach S,Raab H,Treml B,Wally D,Treichl B,Mayr A,Kranewitter C,Oswald Edoi
10.1016/S2352-3026(17)30077-7subject
Has Abstractpub_date
2017-06-01 00:00:00pages
e258-e271issue
6issn
2352-3026pii
S2352-3026(17)30077-7journal_volume
4pub_type
杂志文章,随机对照试验abstract:BACKGROUND:Multiple myeloma is one of the most common haematological malignancies in the USA and is consistently preceded by monoclonal gammopathy of undetermined significance (MGUS). We aimed to assess the association between metformin use and progression of MGUS to multiple myeloma. METHODS:We did a retrospective co...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(14)00037-4
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:Anaemia and iron deficiency are common after post-bariatric abdominoplasty, which can involve removal of large areas of skin with associated blood loss. Because the oral absorbability of iron is reduced after bariatric surgery (through reduced intake, reduction of gastric acid secretion for conjugation of ir...
journal_title:The Lancet. Haematology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/S2352-3026(18)30071-1
更新日期:2018-07-01 00:00:00
abstract:BACKGROUND:High-dose methotrexate-based chemotherapy is standard for primary CNS lymphoma, but most patients relapse. High-dose chemotherapy with autologous stem cell transplantation (HCT-ASCT) is supposed to overcome the blood-brain barrier and eliminate residual disease in the CNS. We aimed to investigate the safety ...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究
doi:10.1016/S2352-3026(16)30050-3
更新日期:2016-08-01 00:00:00
abstract:BACKGROUND:Sintilimab (Innovent Biologics, Suzhou, China), a highly selective, fully humanised, monoclonal antibody, blocks the interaction between PD-1 and its ligands. We aimed to assess the activity and safety profile of sintilimab in Chinese patients with relapsed or refractory classical Hodgkin lymphoma. METHODS:...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究
doi:10.1016/S2352-3026(18)30192-3
更新日期:2019-01-01 00:00:00
abstract:BACKGROUND:The introduction of donors other than HLA-matched siblings has been a pivotal change in stem cell transplantation. We aimed to assess the evolution of outcomes within donor groups over time and explore whether donor-recipient HLA disparity might be advantageous in patients with aggressive disease. METHODS:I...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(19)30158-9
更新日期:2019-11-01 00:00:00
abstract:BACKGROUND:Prevention of graft-versus-host disease (GvHD) without malignant relapse is the overall goal of allogeneic haemopoietic cell transplantation (HCT). We aimed to evaluate regimens using either maraviroc, bortezomib, or post-transplantation cyclophosphamide for GvHD prophylaxis compared with controls receiving ...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,随机对照试验
doi:10.1016/S2352-3026(18)30221-7
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND:High-dose melphalan is of little benefit as a regimen for patients with relapsed or refractory myeloma undergoing an autologous stem-cell transplant (ASCT). The poor performance of single-agent melphalan in this setting prompted us to study a new high-dose combination of infused gemcitabine, busulfan, and me...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(17)30080-7
更新日期:2017-06-01 00:00:00
abstract:BACKGROUND:Data to inform surveillance and treatment for leukaemia predisposition syndromes are scarce and recommendations are largely based on expert opinion. This study aimed to investigate the clinical features and outcomes of patients with myelodysplastic syndrome or acute myeloid leukaemia and Shwachman-Diamond sy...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究
doi:10.1016/S2352-3026(19)30206-6
更新日期:2020-03-01 00:00:00
abstract:BACKGROUND:Panobinostat (a pan histone deacetylase inhibitor) is approved in combination with bortezomib and dexamethasone for patients with relapsed multiple myeloma who have received two or more previous lines of therapy. We aimed to improve the safety of this combination and investigate efficacy by incorporating low...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究
doi:10.1016/S2352-3026(16)30165-X
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND:Gilbert's syndrome is a common inherited disorder of bilirubin metabolism, characterised by mild, unconjugated hyperbilirubinaemia. However, the effect of Gilbert's syndrome on the disposition of some drugs can lead to unexpected toxicity. We tested the hypothesis that patients undergoing myeloablative condi...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(16)30149-1
更新日期:2016-11-01 00:00:00
abstract:BACKGROUND:The optimum preparative regimen for unrelated donor marrow transplantation in patients with severe aplastic anaemia remains to be established. We investigated whether the combination of fludarabine, anti-thymocyte globulin, and total body irradiation (TBI) would enable reduction of the cyclophosphamide dose ...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(15)00147-7
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Mechanisms of red blood cell delivery and their contribution to the incidence of venous thromboembolism are not well understood in the clinical setting. We assessed whether red blood cell transfusion through peripherally inserted central catheters (PICCs) affects the risk of venous thromboembolism compared w...
journal_title:The Lancet. Haematology
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/S2352-3026(16)30132-6
更新日期:2016-12-01 00:00:00
abstract:BACKGROUND:Ponatinib has shown efficacy in patients with refractory chronic myeloid leukaemia (CML) and in those with CML with a Thr315Ile mutation. We aimed to investigate the activity and safety of ponatinib as first-line treatment for patients with chronic-phase CML. METHODS:We did a single-arm, phase 2 trial at MD...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(15)00127-1
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Fit patients with mantle cell lymphoma aged 18-65 years are usually given cytarabine and rituximab-based induction regimens followed by autologous haematopoetic stem-cell transplantation (HSCT). We investigated whether post-autologous HSCT maintenance with lenalidomide improves progression-free survival in t...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/S2352-3026(20)30358-6
更新日期:2021-01-01 00:00:00
abstract:BACKGROUND:Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. METH...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/S2352-3026(19)30219-4
更新日期:2020-01-01 00:00:00
abstract:BACKGROUND:Substantial evidence links exposure to moderate or high doses of ionising radiation, particularly in childhood, with increased risk of leukaemia. The association of leukaemia with exposure to low-dose (<100 mSv) radiation is less certain, although this is the dose range most relevant to the general populatio...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(18)30092-9
更新日期:2018-08-01 00:00:00
abstract:BACKGROUND:Hodgkin's lymphoma is one of the most common lymphoid neoplasms in young adults, but the low abundance of neoplastic Hodgkin/Reed-Sternberg cells in the tumour hampers the elucidation of its pathogenesis, biology, and diversity. After an incidental observation that genomic aberrations known to occur in Hodgk...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(14)00039-8
更新日期:2015-02-01 00:00:00
abstract:BACKGROUND:Leukoencephalopathy is observed in some children undergoing chemotherapy for acute lymphoblastic leukaemia, although its effects on long-term outcomes is unknown. This study examines the associations between acute leukoencephalopathy and neurobehavioural, neurocognitive, and brain white matter imaging outcom...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(16)30110-7
更新日期:2016-10-01 00:00:00
abstract:BACKGROUND:Studies in patients with rheumatoid arthritis have shown that the rituximab biosimilar CT-P10 (Celltrion, Incheon, South Korea) has equivalent efficacy and pharmacokinetics to rituximab. In this phase 3 study, we aimed to assess the non-inferior efficacy and pharmacokinetic equivalence of CT-P10 compared wit...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,随机对照试验
doi:10.1016/S2352-3026(17)30120-5
更新日期:2017-08-01 00:00:00
abstract:BACKGROUND:In patients with chronic lymphocytic leukaemia, achievement of a complete response with minimal residual disease of less than 0·01% (ie, <1 chronic lymphocytic leukaemia cell per 10 000 leukocytes) in bone marrow has been associated with improved progression-free survival. We aimed to explore the activity of...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究
doi:10.1016/S2352-3026(19)30113-9
更新日期:2019-09-01 00:00:00
abstract:BACKGROUND:Intravenous rituximab is the standard of care in B-cell non-Hodgkin lymphoma, and is administered over 1·5-6 h. A subcutaneous formulation could reduce patients' treatment burden and improve resource utilisation in health care. We aimed to show the pharmacokinetic non-inferiority of subcutaneous rituximab to...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,随机对照试验
doi:10.1016/S2352-3026(17)30078-9
更新日期:2017-06-01 00:00:00
abstract:BACKGROUND:Bortezomib with lenalidomide and dexamethasone (VRd) is a standard regimen for the front-line treatment of multiple myeloma. Panobinostat is approved in combination with bortezomib and dexamethasone in patients with myeloma who 'have been given at least two previous regimens including bortezomib and an immun...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(18)30174-1
更新日期:2018-12-01 00:00:00
abstract:BACKGROUND:Although cytomegalovirus viral load is commonly used to guide pre-emptive therapy in the post-transplantation setting, few data are available correlating viraemia with clinical endpoints. We therefore investigated the association between cytomegalovirus viral load and mortality in the first year after haemop...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(15)00289-6
更新日期:2016-03-01 00:00:00
abstract:BACKGROUND:The ability of the pulmonary embolism rule-out criteria (PERC) to exclude pulmonary embolism without further testing remains debated outside the USA, especially in the population with suspected pulmonary embolism who have a high prevalence of the condition. Our main objective was to prospectively assess the ...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究
doi:10.1016/S2352-3026(17)30210-7
更新日期:2017-12-01 00:00:00
abstract:BACKGROUND:Among the syndromes characterised by thrombotic microangiopathy, thrombotic thrombocytopenic purpura is distinguished by a severe deficiency in the ADAMTS13 enzyme. Patients with this disorder need urgent treatment with plasma exchange. Because ADAMTS13 activity testing typically requires prolonged turnaroun...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(17)30026-1
更新日期:2017-04-01 00:00:00
abstract:BACKGROUND:Pegylated interferon alfa-2a is an immunomodulatory agent used to treat polycythemia vera. The durability of responses and long-term safety of this drug in patients with polycythaemia vera and essential thrombocythaemia have not been reported. Here, we present long-term efficacy and safety data from a single...
journal_title:The Lancet. Haematology
pub_type: 临床试验,杂志文章
doi:10.1016/S2352-3026(17)30030-3
更新日期:2017-04-01 00:00:00
abstract:BACKGROUND:Deep vein thrombosis (DVT) and pulmonary embolism are collectively known as venous thromboembolism (VTE), which is a common vascular disease and a major cause of morbidity and mortality worldwide. We compare effectiveness and safety of rivaroxaban versus warfarin in a prospective cohort of routine care patie...
journal_title:The Lancet. Haematology
pub_type: 杂志文章
doi:10.1016/S2352-3026(17)30054-6
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND:The INO-VATE study demonstrated efficacy and safety of inotuzumab ozogamicin versus standard care in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia. Here, we report the frequency of, and potential risk factors for, hepatotoxicity in patients in this trial and after treatment and subs...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,随机对照试验
doi:10.1016/S2352-3026(17)30103-5
更新日期:2017-08-01 00:00:00
abstract:BACKGROUND:Venous thromboembolism is a common complication of cancer, but the risk of developing venous thromboembolism varies greatly among individuals and depends on numerous factors, including type of cancer. We aimed to develop and externally validate a clinical prediction model for cancer-associated venous thrombo...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,多中心研究
doi:10.1016/S2352-3026(18)30063-2
更新日期:2018-07-01 00:00:00
abstract::Machine learning is a branch of computer science and statistics that generates predictive or descriptive models by learning from training data rather than by being rigidly programmed. It has attracted substantial attention for its many applications in medicine, both as a catalyst for research and as a means of improvi...
journal_title:The Lancet. Haematology
pub_type: 杂志文章,评审
doi:10.1016/S2352-3026(20)30121-6
更新日期:2020-07-01 00:00:00