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1. Romiplostim (Nplate) - for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP)

Romiplostim (Nplate) - for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) Final Appraisal Recommendation Advice No: 0119 – February 2019 Romiplostim (Nplate ® ) 125 micrograms powder for solution for injection Limited submission by Amgen Limited Additional note(s): • Please refer to the Summary of Product Characteristics for the full licensed indication. • AWMSG considered that romiplostim (Nplate ® ) satisfied the AWMSG criteria for orphan status. In reaching (...) for review every three years. Recommendation of AWMSG Romiplostim (Nplate ® ) is recommended as an option for use within NHS Wales for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year to < 18 years who are refractory to other treatments (for example, corticosteroids, immunoglobulins). This recommendation applies only in circumstances where the approved Patient Access Scheme (PAS) is utilised or where the list/contract price is equivalent or lower than

2019 All Wales Medicines Strategy Group

2. Caplacizumab-yhdp (Cablivi) - To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP)

Caplacizumab-yhdp (Cablivi) - To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) Drug Approval Package: CABLIVI U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: CABLIVI Company: Ablynx NV Application Number: 761112 Approval Date: 02/06/2019 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review

2019 FDA - Drug Approval Package

3. Immune thrombocytopenic purpura

Immune thrombocytopenic purpura Immune thrombocytopenia - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Immune thrombocytopenia Last reviewed: February 2019 Last updated: March 2019 Summary Immune thrombocytopenia (ITP), also known as immune thrombocytopenic purpura, is defined as an autoimmune haematological disorder characterised by isolated thrombocytopenia in the absence of an identifiable cause. Typically found (...) immune thrombocytopenia (ITP) is a haematological disorder characterised by isolated thrombocytopenia (platelet count <100 × 10⁹/L [<100 × 10³/microlitre]) in the absence of an identifiable cause. Rodeghiero F, Stasi R, Gernsheimer T, et al. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. http://bloodjournal.hematologylibrary.org/cgi/content/full

2018 BMJ Best Practice

4. Henoch-Schonlein purpura

Henoch-Schonlein purpura Henoch-Schonlein purpura - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Henoch-Schonlein purpura Last reviewed: February 2019 Last updated: March 2018 Summary Most common vasculitis of childhood. Rash of palpable purpura is present in all cases. Most cases resolve with symptomatic treatment. Complications can occur, with renal failure being the most common cause of death. Definition Henoch (...) -Schonlein purpura (HSP) is the most common vasculitis of childhood and affects the small vessels. HSP is characterised by the classic tetrad of rash, abdominal pain, arthritis/arthralgia, and glomerulonephritis. Roberts PF, Waller TA, Brinker TM, et al. Henoch-Schonlein purpura: a review article. South Med J. 2007;100:821-824. http://www.ncbi.nlm.nih.gov/pubmed/17713309?tool=bestpractice.com History and exam presence of risk factors arthralgias abdominal pain rash signs of renal disease hx of taking

2018 BMJ Best Practice

5. Caplacizumab (Cablivi) - thrombotic thrombocytopenic purpura (aTTP)

Caplacizumab (Cablivi) - thrombotic thrombocytopenic purpura (aTTP) 30 Churchill Place ? Canary Wharf ? London E14 5EU ? United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact © European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged. 28 June 2018 EMA/490172/2018 Committee for Medicinal Products for Human Use (CHMP) Assessment report Cablivi (...) /490172/2018 Page 4/88 List of abbreviations Ab Antibody ADA anti-drug antibodies ADAMTS13 a disintegrin and metalloprotease with thrombospondin type 1 motif, member 13 AE adverse event ALT alanine aminotransferase aPTT activated partial thromboplastin time ATC Anatomical Therapeutic Chemical AST aspartate aminotransferase aTTP acquired thrombotic thrombocytopenic purpura AUC_D area under the curve dose corrected AUCSS area under the curve at steady state BED biologically effective dose CI confidence

2018 European Medicines Agency - EPARs

8. Romiplostim (Nplate) - chronic immune (idiopathic) thrombocytopenic purpura (ITP)

Romiplostim (Nplate) - chronic immune (idiopathic) thrombocytopenic purpura (ITP) Published 11 February 2019 1 www.scottishmedicines.org.uk Product update SMC2126 romiplostim 125 micrograms, 250 micrograms, 500 micrograms powder for solution for injection (Nplate®) Amgen Ltd 11 January 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice (...) is summarised as follows: ADVICE: following an abbreviated submission romiplostim (Nplate®) is accepted for restricted use within NHSScotland. Indication under review: chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) SMC restriction: to use in patients with severe symptomatic ITP or patients with a high risk of bleeding. Romiplostim has previously been accepted for restricted use

2019 Scottish Medicines Consortium

9. Thrombotic thrombocytopenic purpura

Thrombotic thrombocytopenic purpura Thrombotic thrombocytopenic purpura - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search  Thrombotic thrombocytopenic purpura Last reviewed: February 2019 Last updated: October 2017 Summary This topic focuses on acquired (idiopathic) TTP. TTP is a potential diagnosis in any patient with haemolytic anaemia and thrombocytopenia - 95% of cases are fatal if left untreated. Symptoms (...) therapy is the mainstay of treatment for acute acquired (idiopathic) TTP. Renal and neurological dysfunctions are the main complications. Definition Thrombotic thrombocytopenic purpura (TTP) is a clinical syndrome characterised by microangiopathic haemolytic anaemia and thrombocytopenic purpura. Although the original descriptions included a pentad of microangiopathic haemolytic anaemia, thrombocytopenic purpura, neurological dysfunction, renal dysfunction, and fever, most patients do not have

2017 BMJ Best Practice

10. Solvent Detergent Plasma versus Standard Plasma for the Treatment of Thrombotic Thrombocytopenic Purpura: Comparative Clinical Effectiveness and Cost-Effectiveness

Solvent Detergent Plasma versus Standard Plasma for the Treatment of Thrombotic Thrombocytopenic Purpura: Comparative Clinical Effectiveness and Cost-Effectiveness Solvent Detergent Plasma versus Standard Plasma for the Treatment of Thrombotic Thrombocytopenic Purpura: Comparative Clinical Effectiveness and Cost-Effectiveness | CADTH.ca Find the information you need Solvent Detergent Plasma versus Standard Plasma for the Treatment of Thrombotic Thrombocytopenic Purpura: Comparative Clinical (...) Effectiveness and Cost-Effectiveness Solvent Detergent Plasma versus Standard Plasma for the Treatment of Thrombotic Thrombocytopenic Purpura: Comparative Clinical Effectiveness and Cost-Effectiveness Published on: August 15, 2017 Project Number: RA0920-000 Product Line: Research Type: Devices and Systems Report Type: Reference List Result type: Report Question What is the comparative clinical effectiveness of solvent detergent plasma versus standard plasma for the treatment of thrombotic thrombocytopenic

2017 Canadian Agency for Drugs and Technologies in Health - Rapid Review

11. Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP]

Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP] Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP] - Full Text View (...) - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Prospective Psychometric Evaluation Study of a Patient-reported Outcomes (PRO) Instrument for Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary

2018 Clinical Trials

12. Inherited thrombotic thrombocytopenic purpura mimicking immune thrombocytopenic purpura during pregnancy: a case report Full Text available with Trip Pro

Inherited thrombotic thrombocytopenic purpura mimicking immune thrombocytopenic purpura during pregnancy: a case report Thrombotic thrombocytopenic purpura is a very rare hereditary blood deficiency disorder of ADAMTS13 (von Willebrand factor-cleaving protease) and a life-threatening thrombotic microangiopathy characterized by thrombocytopenia and microangiopathic hemolytic anemia. The deficiency in ADAMTS13 metalloprotease, which cleaves the von Willebrand factor, may be congenital or acquired (...) thrombocytopenic purpura may mimic the signs and symptoms of pre-eclampsia/eclampsia, hemolysis with elevated liver enzymes and low platelet count syndrome, and atypical hemolytic-uremic syndrome. It should be considered in suspect cases in patients with an ADAMTS13 activity at 5% without ADAMTS13 antibodies.

2018 Journal of medical case reports

13. Atypical purpura location in a pediatric patient with Henoch-Schönlein purpura: A case report. Full Text available with Trip Pro

Atypical purpura location in a pediatric patient with Henoch-Schönlein purpura: A case report. The presence of purpura is a compulsory criteria for the diagnosis of Henoch-Schönlein purpura (HSP). Typical purpura of HSP is distributed symmetrically over the extensor surfaces of the lower limbs, buttocks, and forearms with the occasional involvement of trunk and face in children. It occurs only involving the bottom of the feet has never been reported.A 7-year-old girl was admitted (...) to the hospital with abdominal pain, vomiting, and fever.Combining clinical manifestations with results of radiologic examinations, acute appendicitis was suspected and a laparotomy was considered. Purpura was found on the bottom of her feet when she was in the operating room and HSP was diagnosed.The patient was treated with glucocorticosteroids, antibiotics, cimetidine, and restriction of feeding.The abdominal pain and purpura resolved at discharge and there were no recurrences in the subsequent 3-, 6

2018 Medicine

14. Post-Partum Thrombotic Thrombocytopenic Purpura (TTP) in a Patient with known Idiopathic (Immune) Thrombocytopenic Purpura: a case report and review of the literature Full Text available with Trip Pro

Post-Partum Thrombotic Thrombocytopenic Purpura (TTP) in a Patient with known Idiopathic (Immune) Thrombocytopenic Purpura: a case report and review of the literature Incidences of immune thrombocytopenic purpura occur in 1 in every 1000-10,000 pregnancies accounting for 3% of all thrombocytopenic pregnancies. A pre-existing immune thrombocytopenic purpura is known to be a risk factor for developing thrombocytopenia during pregnancy. We present here the treatment regime and management (...) of a patient with known immune thrombocytopenic purpura who developed postpartum thrombotic thrombocytopenia with atypical response to traditional therapy. Pregnant women are more vulnerable to immune thrombocytopenic purpura or thrombotic thrombocytopenia. Pregnancy or postpartum thrombotic thrombocytopenia accounts for 10-25% of all thrombotic thrombocytopenia.This case report deals with the treatment regime and management of a patient with known immune thrombocytopenic purpura who developed postpartum

2018 Journal of medical case reports

15. Eltrombopag (Revolade) - for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP)

Eltrombopag (Revolade) - for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) Final Appraisal Recommendation Advice No: 2916 – October 2016 Eltrombopag (Revolade ® ) 25 mg, 50 mg film coated tablets and 25 mg powder for oral suspension Limited submission by Novartis Pharmaceuticals UK Ltd Additional note(s): • Please refer to the Summary of Product Characteristics for the full licensed indication. In reaching the above recommendation AWMSG has taken account (...) of this recommendation may be reproduced without the whole recommendation being quoted in full and cited as: All Wales Medicines Strategy Group. Final Appraisal Recommendation – 2916: Eltrombopag (Revolade ® ) 25 mg, 50 mg film coated tablets and 25 mg powder for oral suspension. October 2016. Recommendation of AWMSG Eltrombopag (Revolade ® ) is recommended as an option for use within NHS Wales for the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients aged 1 year to < 18 years who

2016 All Wales Medicines Strategy Group

16. Immune (idiopathic) thrombocytopenic purpura: rituximab

Immune (idiopathic) thrombocytopenic purpura: rituximab Immune (idiopathic) thrombocytopenic purpur Immune (idiopathic) thrombocytopenic purpura: a: rituximab rituximab Evidence summary Published: 21 October 2014 nice.org.uk/guidance/esuom35 pathways K Ke ey points from the e y points from the evidence vidence The content of this evidence summary was up-to-date in October 2014. See summaries of product characteristics (SPCs), British national formulary (BNF), BNF for children (BNFc) or the MHRA (...) or NICE websites for up-to-date information. Summary Most of the evidence for using rituximab in adults with immune thrombocytopenic purpura comes from observational studies, with no comparator arm. The populations in the included studies varied, as did the platelet count considered to represent an overall response or complete response. The randomised controlled trials (RCTs) discussed in this evidence summary had a number of limitations, including small numbers of participants. All of these factors

2014 National Institute for Health and Clinical Excellence - Advice

17. Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura. Full Text available with Trip Pro

Caplacizumab Treatment for Acquired Thrombotic Thrombocytopenic Purpura. In acquired thrombotic thrombocytopenic purpura (TTP), an immune-mediated deficiency of the von Willebrand factor-cleaving protease ADAMTS13 allows unrestrained adhesion of von Willebrand factor multimers to platelets and microthrombosis, which result in thrombocytopenia, hemolytic anemia, and tissue ischemia. Caplacizumab, an anti-von Willebrand factor humanized, bivalent variable-domain-only immunoglobulin fragment

2019 NEJM Controlled trial quality: predicted high

18. Interventions for preventing and treating kidney disease in Henoch-Schönlein Purpura (HSP). (Abstract)

Interventions for preventing and treating kidney disease in Henoch-Schönlein Purpura (HSP). Henoch-Schönlein purpura (HSP) is the most common vasculitis of childhood but may occur in adults. This small vessel vasculitis is characterised by palpable purpura, abdominal pain, arthritis or arthralgia and kidney involvement. This is an update of a review first published in 2009.To evaluate the benefits and harms of different agents (used singularly or in combination) compared with placebo

2015 Cochrane

19. Persistence of endothelial thrombomodulin in a patient with infectious purpura fulminans treated with protein C concentrate Full Text available with Trip Pro

Persistence of endothelial thrombomodulin in a patient with infectious purpura fulminans treated with protein C concentrate 30396911 2018 12 07 2473-9537 2 21 2018 Nov 13 Blood advances Blood Adv Persistence of endothelial thrombomodulin in a patient with infectious purpura fulminans treated with protein C concentrate. 2917-2921 10.1182/bloodadvances.2018024430 Bendapudi Pavan K PK Division of Hematology and Blood Transfusion Service, Massachusetts General Hospital, Boston, MA. Division

2018 Blood advances

20. The remarkable diversity of thrombotic thrombocytopenic purpura: a perspective Full Text available with Trip Pro

The remarkable diversity of thrombotic thrombocytopenic purpura: a perspective Understanding the autoimmune etiology of acquired thrombotic thrombocytopenic purpura (TTP) has provided precision for the diagnosis and a rationale for immunosuppressive treatment. These advances have also allowed recognition of the remarkable clinical diversities of patients' initial presentations and their long-term outcomes. These diversities are illustrated by the stories of patients from the Oklahoma TTP

2018 Blood advances

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