Pc Matic Free Trial

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Natalí Stibb

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Aug 3, 2024, 5:12:48 PM8/3/24
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Design: Secondary analysis of the MAssive Transfusion epidemiology and outcomes In Children study dataset, a prospective observational study of children with life-threatening bleeding events.

Intervention/exposure: Weight-adjusted blood product volumes received during the bleeding event were recorded. Plasma:RBC ratio (plasma/RBC weight-adjusted volume in mL/kg) and platelet:RBC ratio (platelet/RBC weight-adjusted volume in mL/kg) were analyzed. Plasma deficit was calculated as RBC mL/kg - plasma mL/kg; platelet deficit was calculated as RBC mL/kg - platelet mL/kg.

Conclusions: In injured children, balanced resuscitation may improve early survival according to this hypothesis generating study. Multicenter clinical trials are needed to assess whether clinicians should target ratios and deficits as optimal pediatric hemostatic resuscitation practice.

Trauma is the leading cause of death in children. There have been no large-scale clinical trials to guide the best way to resuscitate children with life-threatening bleeding from traumatic injury. The MATIC-2 Trial is being conducted so that doctors can know how best to treat children who are severely injured and bleeding.

There are several ways that doctors treat children in the US with severe bleeding. The purpose of this study is to determine which bundle of care is best for injured children. In the US, most blood that is donated is separated into blood components because it can be used to help more people that way. Therefore, many injured children receive blood components (red blood cells, plasma, platelets) instead of whole blood. While there is some evidence that whole blood might be better when treating injured children we do not currently know whether whole blood or blood components are more helpful to people who need large amounts of blood after injury. The results of this study may be used to determine whether more whole blood will be made available for use in injured children. Additionally, children in this trial may receive a drug called tranexamic acid (TXA) which helps stabilize clots that form to stop bleeding. Tranexamic acid is the standard of care for injured adults and is used for other causes of bleeding in children, and there is some evidence that suggests that tranexamic acid might also benefit children who are bleeding as a result of trauma. All of these treatments included in this study are used routinely in children with life-threatening bleeding from trauma.

Children in this study will have suffered a serious and potentially life-threatening injury, resulting in significant blood loss. Because blood transfusions and lifesaving care must begin very soon after injured children arrive at the hospital, it is not possible for guardians to provide consent in advance to enter a study. Doctors will therefore enroll children into the study without obtaining parental consent in advance and get consent for continued participation after the child is stable.

Life-threatening bleeding occurs from many etiologies in children, such as intra and post-operative bleeding, gastrointestinal bleeding, disseminated intravascular coagulation, and traumatic injury. The epidemiology, therapies commonly used, and outcomes related to severe hemorrhage has not been systematically studied in children, and is a major gap in our knowledge in this high-risk population. Damage Control Resuscitation (DCR) principles have been developed to reduce death from hemorrhage in adult trauma patients. One important concept within DCR is called hemostatic resuscitation, which has been defined as a high ratio of plasma and platelets to RBCs (> 1:2 units), as well as a small plasma deficit (RBC total units - plasma total units), both starting very early in the resuscitation. To implement hemostatic resuscitation, Massive Transfusion protocols (MTP) have been developed in many adult and pediatric tertiary care centers. Despite a paucity of evidence supporting hemostatic resuscitation in children, it is being generalized to pediatric practice for both traumatic and non-traumatic etiologies. The MAssive Transfusion epidemiology and outcomes In Children (MATIC) study is a multicenter, prospective, observational study that will collect data on all MTP activations on children at participating centers. The goal of this study is to determine the epidemiology, therapies used, and outcomes for children requiring MTP activation from all etiologies. We will prospectively collect data on all MTP activations in a consecutive sample of approximately 502 patients from 35 academic pediatric tertiary care centers into a web-based database over a 22-month period. We will determine if patient specific factors and inter-hospital variability are associated with MTP practice and outcomes. Our primary hypothesis is that morbidity and mortality outcomes will vary by patient illness category (operative vs traumatic vs medical). We also aim to determine if early and sustained hemostatic resuscitation is associated with increased survival in children with traumatic injury requiring MTP activation. We have collected preliminary data indicating the feasibility of the study and validity of the data collection methods. We have also limited the analysis of hemostatic resuscitation on outcomes to children with traumatic injury to reduce heterogeneity in the study population. This study is innovative due to the absence of pediatric multicenter data published on the epidemiology, therapies, and outcomes for children in this population. Our statistical analysis is also innovative. We will develop a sophisticated model that will incorporate propensity scores with the timing, ratio, and deficits of plasma and platelets to RBCs to determine if ?hemostatic resuscitation? is associated with improved outcomes. Completion of this study will provide preliminary data that will provide support for large comparative effectiveness studies to determine which DCR principles affect outcomes in children with or without traumatic injury with severe life-threatening bleeding. High quality trials are essential to improve clinical practice since the mortality in this population ranges from 35 to 78%.

The MAssive Transfusion epidemiology and outcomes In Children (MATIC) study is a multicenter, prospective, observational study that will collect data on approximately 502 pediatric patients at approximately 35 sites on all massive transfusion protocols (MTP) activations at participating centers over a 22-month period into an electronic database. The goal of this study is to determine indications, frequency, therapies used, and outcomes for children requiring MTP activation as well as to determine if early and sustained hemostatic resuscitation is associated with increased survival in children requiring MTP activation by analyzing the specific timing of each blood product transfused, as well as the ratios and deficits of plasma and platelets to RBCs.

**When working with datasets larger than 1GB the system should comply with the recommended system requirements. Advanced segmentation tools such as Smart Expand, and Coronary segmentation require hardware as specified in the recommended requirements even for smaller datasets. When working with 4D or multi-stack data, the amount of RAM needed increases as you import more image series into the project.

The Medical edition of the Materialise Mimics Innovation Suite currently consists of the following software components: Materialise Mimics Medical version 26.0 and Materialise 3-matic Medical version 18.0 (released 2023). Mimics Medical is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. Mimics Medical is also intended for measuring and treatment planning. The Mimics Medical output can be used for the fabrication of physical replicas of the output file using traditional or additive manufacturing methods. The physical replica can be used for diagnostic purposes in the field of orthopedic, maxillofacial and cardiovascular applications. Mimics Medical should be used in conjunction with expert clinical judgement. 3-matic Medical is intended for use as software for computer-assisted design and manufacturing of medical exo- and endo-prostheses, patient-specific medical and dental/orthodontic accessories and dental restorations.

The Materialise Mimics Innovation Suite currently consists of the following software components: Materialise Mimics version 26.0 and Materialise 3-matic version 18.0 (released 2023). Materialise Mimics and Materialise 3-matic are not medical devices.
Mimics Medical and 3-matic Medical are medical devices and CE-marked products.

The below list of 3D printers has been validated for use with Mimics Medical for the creation of diagnostics 3D models. Please refer to the Mimics Medical user manual for additional instructions on good manufacturing practices for medical models. Other printers may be used with Mimics Medical, however, these have not been validated by Materialise for the creation of diagnostic 3D printed models.

Materialise medical device software may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. In countries where no regulatory registration is obtained of Mimics and/or 3-matic Medical, a research version is available. Please contact your Materialise representative if you have questions about the availability of Materialise medical device software in your area.

my company is using the Pix4D Matic trial for a rather large dataset. (Almost 72 hours after beginning and we have reach the 50% mark! ) We are pretty pleased with the software so far and will be upgrading to P4DMatic. As we go, we are comparing it to Pix4DMapper, using the same enormous dataset.

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