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

The TESTING (Therapeutic Evaluation of STeroids in IgA Nephropathy Global) study is a multicenter, double-blinded, randomised, placebo-controlled trial designed to evaluate the long-term efficacy and safety of oral methylprednisolone, on a background of routine renin angiotensin system (RAS) inhibitor therapy, in preventing kidney events in patients with IgA nephropathy with features suggestive of a high risk of disease progression. This statistical analysis plan (SAP) provides the details of all pre-specified analyses to be conducted at the end of the trial. The SAP was written by the trial statistician, chief investigator, study director and project manager and approved by the management committee.

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Statistical analysis plan for the Stroke Oxygen Study (SO2S): a multi-center randomized controlled trial to assess whether routine oxygen supplementation in the first 72 hours after a stroke improves long-term outcome

Trials ◽

10.1186/1745-6215-15-229 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 1

Author(s):

Julius Sim ◽

Richard Gray ◽

Tracy Nevatte ◽

Andrew Howman ◽

Natalie Ives ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Statistical Analysis ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Oxygen Supplementation ◽

Term Outcome ◽

Long Term Outcome ◽

Randomized Controlled

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Statistical analysis plan for the Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients with Acute Respiratory Failure trial

Critical Care and Resuscitation ◽

10.51893/2020.1.oa7 ◽

2020 ◽

Vol 22 (1) ◽

pp. 63-71

Author(s):

Rameela Chandrasekhar ◽

◽

Christopher G Hughes ◽

Brenda T Pun ◽

Onur M Orun ◽

...

Keyword(s):

Statistical Analysis ◽

Randomised Trial ◽

Randomised Clinical Trial ◽

Statistical Analysis Plan ◽

Brain Dysfunction ◽

Neurological Dysfunction ◽

Long Term Effects ◽

Double Blind ◽

Mechanically Ventilated

BACKGROUND: The best sedative medication to reduce delirium, mortality and long term brain dysfunction in mechanically ventilated septic patients is unclear. This multicentre, double-blind, randomised trial investigates the short term and long term effects of dexmedetomidine versus propofol for sedation in mechanically ventilated severely septic patients. OBJECTIVES: To describe the statistical analysis plan for this randomised clinical trial comprehensively and place it in the public domain before unblinding. METHODS: To ensure that analyses are not selectively reported, we developed a comprehensive statistical analysis plan before unblinding. This trial has an enrolment target of 420 severely septic and mechanically ventilated adult patients, randomly assigned to dexmedetomidine or propofol in a 1:1 ratio. Enrolment was completed in January 2019, and the study was estimated to be completed in September 2019. The primary endpoint is days alive without delirium or coma during first 14 study days. Secondary outcomes include 28-day ventilator-free days, 90-day all-cause mortality and cognitive function at 180 days. Time frames all begin on the day of randomisation. All analyses will be conducted on an intention-to-treat basis. CONCLUSION: This study will compare the effects of two sedatives in mechanically ventilated severely septic patients. In keeping with the guidance on statistical principles for clinical trials, we have developed a comprehensive statistical analysis plan by which we will adhere, as this will avoid bias and support transparency and reproducibility. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01739933).

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

Acta Anaesthesiologica Scandinavica ◽

10.1111/aas.13434 ◽

2019 ◽

Vol 63 (9) ◽

pp. 1262-1271 ◽

Cited By ~ 4

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

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

Acta Anaesthesiologica Scandinavica ◽

10.1111/aas.13599 ◽

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

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Statistical analysis plan (SAP) for the 5- and 10-year follow-up assessments of the FIDELITY trial

10.21203/rs.2.12491/v1 ◽

2019 ◽

Author(s):

Raine Sihvonen ◽

Roope Kalske ◽

Martin Englund ◽

Aleksandra Turkiewicz ◽

Pirjo Toivonen ◽

...

Keyword(s):

Statistical Analysis ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Meniscus Tear ◽

Meniscal Lesion ◽

Long Term Outcomes ◽

Arthroscopic Partial Meniscectomy ◽

Adult Age

Abstract Background The research objectives of the 5- and 10-year assessments of the Finnish Degenerative Meniscal Lesion Study (FIDELITY) are two-fold: 1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adult (age 35 to 65 years) patients with a degenerative meniscus tear, and 2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and Design FDELITY is an ongoing multi-centre, randomized, participant and outcome assessor blinded, placebo-surgery controlled trial of 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5- and 10-year follow-ups), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses.

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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

Wellcome Open Research ◽

10.12688/wellcomeopenres.10383.1 ◽

2016 ◽

Vol 1 ◽

pp. 31 ◽

Cited By ~ 6

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).

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Statistical analysis plan for the 5- and 10-year follow-up assessments of the FIDELITY trial

10.21203/rs.2.12491/v2 ◽

2019 ◽

Author(s):

Raine Sihvonen ◽

Roope Kalske ◽

Martin Englund ◽

Aleksandra Turkiewicz ◽

Pirjo Toivonen ◽

...

Keyword(s):

Statistical Analysis ◽

Knee Osteoarthritis ◽

Controlled Trial ◽

Statistical Analysis Plan ◽

Primary Objective ◽

Meniscus Tear ◽

Second Primary ◽

Term Efficacy

Abstract Background: The research objectives of the 5- and 10-year assessments of the Finnish Degenerative Meniscal Lesion Study (FIDELITY) are two-fold: 1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adult (age 35 to 65 years) patients with a degenerative meniscus tear, and 2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and Design: FDELITY is an ongoing multi-centre, randomized, participant and outcome assessor blinded, placebo-surgery controlled trial of 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5- and 10-year follow-ups), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. Discussion: To study whether APM (resection of torn meniscus tear) per se accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically-verified degenerative tear of the medial meniscus, we are carrying out pre-registered long-term (5- and 10-year) follow-up of our placebo-surgery controlled FIDELITY trial according to statistical principles outlined in detail in this document. We have also outlined the analyses intended to assess our second primary objective, the long-term efficacy of APM on knee symptoms and function.

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