scholarly journals Conservative vs liberal fluid therapy in septic shock (CLASSIC) trial—Protocol and statistical analysis plan

2019 ◽  
Vol 63 (9) ◽  
pp. 1262-1271 ◽  
Author(s):  
Tine Sylvest Meyhoff ◽  
Peter Buhl Hjortrup ◽  
Morten Hylander Møller ◽  
Jørn Wetterslev ◽  
Theis Lange ◽  
...  
Keyword(s):  
Septic Shock ◽  
Statistical Analysis ◽  
Fluid Therapy ◽  
Statistical Analysis Plan ◽  
Trial Protocol

scholarly journals Low‐dose hydrocortisone in patients with COVID‐19 and severe hypoxia (COVID STEROID) trial—Protocol and statistical analysis plan

2020 ◽  
Vol 64 (9) ◽  
pp. 1365-1375 ◽  
Author(s):  
Marie Warrer Petersen ◽  
Tine Sylvest Meyhoff ◽  
Marie Helleberg ◽  
Maj‐Brit Nørregaard Kjær ◽  
Anders Granholm ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Low Dose ◽  
Statistical Analysis Plan ◽  
Severe Hypoxia ◽  
Trial Protocol

scholarly journals Noninterventional follow‐up vs fluid bolus in RESPONSE to oliguria—The RESPONSE trial protocol and statistical analysis plan

2020 ◽  
Vol 64 (8) ◽  
pp. 1210-1217
Author(s):  
Nina Inkinen ◽  
Tuomas Selander ◽  
Ville Pettilä ◽  
Miia Valkonen ◽  
Minna Bäcklund ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Trial Protocol ◽  
Fluid Bolus ◽  
Response Trial

scholarly journals The Plasma-Lyte 148 versus Saline (PLUS) statistical analysis plan: a multicentre, randomised controlled trial of the effect of intensive care fluid therapy on mortality

2021 ◽  
Vol 23 (1) ◽  
pp. 24-31
Author(s):  
Laurent Billot ◽  
◽  
Rinaldo Bellomo ◽  
Martin Gallagher ◽  
David Gattas ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Randomised Controlled Trial ◽  
Fluid Resuscitation ◽  
Fluid Therapy ◽  
Controlled Trial ◽  
Internal Validity ◽  
Statistical Analysis Plan ◽  
Sensitivity Analyses ◽  
Process Measures ◽  
Randomised Controlled

BACKGROUND AND OBJECTIVE:The Plasma-Lyte 148 versus Saline (PLUS) study is a prospective, multicentre, parallel-group, concealed, blinded, randomised controlled trial comparing the effect of Plasma-Lyte 148 versus 0.9% sodium chloride (saline) for fluid resuscitation and other fluid therapy on 90-day mortality among critically ill adults requiring fluid resuscitation. The original target for recruitment was 8800 participants, which was reduced to 5000 participants following the onset of the coronavirus disease 2019 (COVID-19) pandemic in 2020. This article describes the statistical analysis plan for the PLUS study. METHODS: The statistical analysis plan was developed by the study statistician, chief investigator, and project manager, and was approved by the Management Committee before unblinding. The plan describes in detail the analysis of baseline characteristics, process measures, and outcomes, including covariate adjustments, subgroup analyses, missing data handling, and sensitivity analyses. RESULTS AND CONCLUSIONS: A statistical analysis plan for the PLUS study was developed. This pre-specified plan accords with high quality standards of internal validity and should minimise future analysis bias.

scholarly journals Effect of tranexamic acid on coagulation and fibrinolysis in women with postpartum haemorrhage (WOMAN-ETAC): protocol and statistical analysis plan for a randomized controlled trial

2016 ◽  
Vol 1 ◽  
pp. 31 ◽  
Author(s):  
Haleema Shakur ◽  
Bukola Fawole ◽  
Modupe Kuti ◽  
Oladapo O. Olayemi ◽  
Adenike Bello ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Statistical Analysis ◽  
Tranexamic Acid ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Statistical Analysis Plan ◽  
Trial Protocol ◽  
Randomized Controlled ◽  
Link Type ◽  
Trial Participants

Background: Postpartum haemorrhage (PPH) is a leading cause of maternal death. Tranexamic acid has the potential to reduce bleeding and a large randomized controlled trial of its effect on maternal health outcomes in women with PPH (The WOMAN trial) is ongoing. We will examine the effect of tranexamic acid on fibrinolysis and coagulation in a subset of WOMAN trial participants. Methods: Adult women with clinically diagnosed primary PPH after vaginal or caesarean delivery are eligible for inclusion in the WOMAN trial. In a sub-group of trial participants, blood samples will be collected at baseline and 30 minutes after the first dose of tranexamic acid or matching placebo.  Our primary objective is to evaluate the effect of tranexamic acid on fibrinolysis. Fibrinolysis will be assessed by measuring D-dimers and by rotational thromboelastometry (ROTEM). Secondary outcomes are international normalized ratio (INR), prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, haemoglobin and platelets. We aim to include about 180 women from the University College Hospital, Ibadan in Nigeria. Discussion: This sub-study of WOMAN trial participants should provide information on the mechanism of action of tranexamic acid in women with postpartum haemorrhage. We present the trial protocol and statistical analysis plan. The trial protocol was registered prior to the start of patient recruitment. The statistical analysis plan was completed before un-blinding. Trial registration:The trial was registered:ClinicalTrials.gov, Identifier NCT00872469https://clinicaltrials.gov/ct2/show/NCT00872469; ISRCTN registry, Identifier ISRCTN76912190http://www.isrctn.com/ISRCTN76912190(Registration date: 22/03/2012).

scholarly journals Higher vs lower doses of dexamethasone in patients with COVID‐19 and severe hypoxia (COVID STEROID 2) trial: Protocol and statistical analysis plan

2021 ◽  
Author(s):  
Marie Warrer Munch ◽  
Anders Granholm ◽  
Sheila Nainan Myatra ◽  
Bharath Kumar Tirupakuzhi Vijayaraghavan ◽  
Maria Cronhjort ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Severe Hypoxia ◽  
Trial Protocol

Long‐term cognitive and pulmonary functions following a lower versus a higher oxygenation target in the HOT‐ICU trial – protocol and statistical analysis plan

2021 ◽  
Author(s):  
Elena Crescioli ◽  
Jens Østergaard Riis ◽  
Ulla Møller Weinreich ◽  
Jens Ulrik Stæhr Jensen ◽  
Lone Musaeus Poulsen ◽  
...  
Keyword(s):  
Statistical Analysis ◽  
Statistical Analysis Plan ◽  
Trial Protocol ◽  
Pulmonary Functions
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