Restart TICrH: An Adaptive Randomized Trial of Time Intervals to Restart Direct Oral Anticoagulants after Traumatic Intracranial Hemorrhage

Milling, Truman J.; Warach, Steven; Gajewski, Byron; Costantini, Todd W.; Price, Michelle; Wick, Jo; Roward, Simin; Mudaranthakam, Dinesh Pal; Dula, Adrienne N.; King, Benjamin T.; Muddiman, Alexander; Lip, Gregory Y.H.

doi:10.1089/neu.2020.7535

Cited by 12 publications

(15 citation statements)

References 50 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…This is consistent with literature that calls for studying the optimal timing of restarting anticoagulation among geriatric traumatic intracranial hemorrhage patients. 43 Geriatric trauma patients are frequently on long-term anticoagulation for prothrombotic comorbid cerebrovascular and cardiovascular conditions. Traumatic brain injury is associated with higher rates of thromboembolic complications, especially among geriatric TBI patients.…”

Section: Discussionmentioning

confidence: 99%

Developing a National Trauma Research Action Plan: Results from the geriatric research gap Delphi survey

Joseph¹,

Saljuqi²,

Phuong³

et al. 2022

J Trauma Acute Care Surg

View full text Add to dashboard Cite

BACKGROUND: Treating older trauma patients requires a focus on the confluence of age-related physiological changes and the impact of the injury itself.Therefore, the primary way to improve the care of geriatric trauma patients is through the development of universal, systematic multidisciplinary research. To achieve this, the Coalition for National Trauma Research has developed the National Trauma Research Action Plan that has generated a comprehensive research agenda spanning the continuum of geriatric trauma care from prehospital to rehabilitation. METHODS:Experts in geriatric trauma care and research were recruited to identify current gaps in clinical geriatric research, generate research questions, and establish the priority of these questions using a consensus-driven Delphi survey approach. Participants were identified using established Delphi recruitment guidelines ensuring heterogeneity and generalizability. On subsequent surveys, participants were asked to rank the priority of each research question on a nine-point Likert scale, categorized to represent low-, medium-, and high-priority items. The consensus was defined as more than 60% of panelists agreeing on the priority category. RESULTS:A total of 24 subject matter experts generated questions in 109 key topic areas. After editing for duplication, 514 questions were included in the priority ranking. By round 3, 362 questions (70%) reached 60% consensus. Of these, 161 (44%) were high, 198 (55%) medium, and 3 (1%) low priority. CONCLUSION: Among the questions prioritized as high priority, questions related to three types of injuries (i.e., rib fracture, traumatic brain injury, and lower extremity injury) occurred with the greatest frequency.Among the 25 highest priority questions, the key topics with the highest frequency were pain management, frailty, and anticoagulation-related interventions. The most common types of research proposed were interventional clinical trials and comparative effectiveness studies, outcome research, and health care systems research.

show abstract

Section: Discussionmentioning

confidence: 99%

Developing a National Trauma Research Action Plan: Results from the geriatric research gap Delphi survey

Joseph¹,

Saljuqi²,

Phuong³

et al. 2022

J Trauma Acute Care Surg

View full text Add to dashboard Cite

show abstract

“…This does cut both ways with bleeding and thrombosis events, i.e., an ICH expansion may be worse than a deep vein thrombosis, but an ischemic stroke is generally worse than a GI bleed. Balancing the severity of bleeding and thrombotic components of composite outcomes has never been done even in prospective trials (though it is a secondary analysis in Restart TICrH 20 ) and would not be possible in this model. It requires correlating the events with functional scales such as modified Rankin Scales performed later and does raise the problem of what scales to use across the several outcome events, stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, GI hemorrhage, recurrent ICH, and other hemorrhage.…”

Section: Discussionmentioning

confidence: 99%

“…It is not the same thing as finding that a time point is a “best” restart time. This can only be accomplished in randomized models comparing different timing strategies (such as the Restart TICrH trial 20 ) in which each group has a specified restart day. Patients in our dataset could be restarted at any time in the 30-day follow-up.…”

Section: Discussionmentioning

confidence: 99%

Restart of Anticoagulant Therapy and Risk of Thrombosis, Rebleeding, and Death after Factor Xa Inhibitor Reversal in Major Bleeding Patients

Milling¹,

King

Yue

et al. 2021

Thromb Haemost

Self Cite

View full text Add to dashboard Cite

Background: Lack of data on balancing bleeding and thrombosis risk causes uncertainty about restarting anticoagulants after major bleeding. Anticoagulant reversal trials offer prospectively gathered data after major bleeding with well-documented safety events and restarting behavior. Objectives: To examine the relationship of restarting anticoagulation with thrombosis, rebleeding and death. Patients/Methods: This is a post hoc analysis of a prospective factor Xa inhibitor reversal study at 63 centers in North America and Europe. We compared outcomes of restarted patients with those not restarted using landmark and time-dependent Cox Proportional Hazards models. Outcomes included thrombotic and bleeding events and death and a composite of all three. Results: Of 352 patients enrolled, oral anticoagulation was restarted in 100 (28%) during 30-day follow-up. Thirty-four (9.7%) had thrombotic events, 15 (4.3%) had bleeding events (after day 3) and 49 (14%) died. In the landmark analysis comparing patients restarted within 14 days to those not, restarting was associated with decreased thrombotic events (hazard ratio [HR]=0.112; 95% CI, 0.001 to 0.944; P=0.043) and increased rebleeding (HR=8.39; 95% CI, 1.13 to 62.29; P=0.037). The time-dependent Cox model showed evidence for a reduction in a composite (thrombotic events, bleeding and death) attempting to capture net benefit (HR=0.384; 95% CI, 0.161 to 0.915; P=0.031). Conclusions: This analysis provides modest evidence that restarting anticoagulation in factor Xa inhibitor-associated major bleeding patients is correlated with reduced risk of thrombotic events and increased risk of re-bleeding. There is low-level evidence of net benefit for re-starting. A randomized trial of re-starting would be appropriate.

show abstract

“…It also creates the possibility of simpler methods 9 for a "meta-repository" of multiple clinical trials. We will apply these innovations to a randomized trial of timing of restarting direct oral anticoagulants after traumatic intracranial hemorrhage (Restart TICrH NCT04229758) 10 .…”

Section: Discussionmentioning

confidence: 99%

Smartphone Imaging Repository: A Novel, Cost-Effective Method For Creating a CT Image Bank

Dula

Milling

Aydelotte³

et al. 2021

Preprint

Self Cite

View full text Add to dashboard Cite

BackgroundImaging repositories are commonly attached to ongoing clinical trials for efficiency and cost savings, but capturing, transmitting and storing images can be cumbersome and increase costs. Typical methods include outdated technologies such as compact discs. Electronic file transfer is becoming more common, but even this requires hours of staff time on dedicated computers in the radiology department.MethodsWe describe and test an image capture method using smartphone camera video images of brain computed tomography (CT) scans of traumatic intracranial hemorrhage. The deidentified videos are emailed from the emergency department for central adjudication. We selected eight scans, mild moderate and severe subdural and multicompartmental hematomas and mild and moderate intraparenchymal hematomas. Eighty videos were made by 10 people on 7 different smartphones. We measured the time in seconds it took to capture and email the files. The primary outcomes were hematoma volume measured by ABC/2, Marshal Scale, midline shift measurement, image quality by contrast-to-noise ratio (CNR) and time to capture. A radiologist and an imaging scientist applied ABC/2 method, calculated the Marshall scale and midline shift on the video images and on the PACS in a randomized order. We calculate the intraclass correlation coefficient (ICC). We measured image quality by calculating contrast-to-noise ratio (CNR). We report summary statistics on time to capture in the smartphone group without a comparator.ResultsICC for lesion volume, midline shift and Marshall score were 0.991 (95% CI 0.976, 0.998), 0.998 (95% CI: 0.996, 0.999) and 0.973 (0.931, 0.994) respectively. Lesion conspicuity was not different among the image types via assessment of CNR using the Friedman test, Bof 10.6, P=.061, with a small Kendall’s W effect size (0.264). Mean (standard deviation) time to capture and email the video was 60.1 (24.3) seconds.ConclusionsTypical smartphones may produce video image quality high enough for use in a clinical trial imaging repository. Video capture and transfer takes only seconds, and hematoma volumes, Marshal scales and image quality measured on the videos did not differ significantly from those calculated on the PACS.

show abstract

Restart TICrH: An Adaptive Randomized Trial of Time Intervals to Restart Direct Oral Anticoagulants after Traumatic Intracranial Hemorrhage

Cited by 12 publications

References 50 publications

Developing a National Trauma Research Action Plan: Results from the geriatric research gap Delphi survey

Developing a National Trauma Research Action Plan: Results from the geriatric research gap Delphi survey

Restart of Anticoagulant Therapy and Risk of Thrombosis, Rebleeding, and Death after Factor Xa Inhibitor Reversal in Major Bleeding Patients

Smartphone Imaging Repository: A Novel, Cost-Effective Method For Creating a CT Image Bank

Contact Info

Product

Resources

About