Restart TICrH Trial Design: an adaptive randomized trial of time intervals to restart direct oral anticoagulants after traumatic intracranial hemorrhage.

2021 ◽  
Author(s):  
TJ Milling ◽  
Steven Warach ◽  
S. Claiborne Johnston ◽  
Byron J. Gajewski ◽  
Todd Costantini ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Intracranial Hemorrhage ◽  
Trial Design ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Time Intervals ◽  
Traumatic Intracranial Hemorrhage

Abstract WMP98: A Nationwide Study of Non-traumatic Intracranial Hemorrhage in Patients Receiving Direct Oral Anticoagulant Therapy: J-Aspect Study

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Ryota Kurogi ◽  
Kunihiro Nishimura ◽  
Akiko Kada ◽  
Satoru Kamitani ◽  
Kuniaki Ogasawara ◽  
...  
Keyword(s):  
Intracranial Hemorrhage ◽  
Oral Anticoagulant Therapy ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Nationwide Survey ◽  
Annual Number ◽  
Prescription Data ◽  
Nationwide Study ◽  
Number Of Patients ◽  
Traumatic Intracranial Hemorrhage

Background and purpose: The incidence of non-traumatic intracranial hemorrhage (ICH) during treatment with direct oral anticoagulants (DOACs) is lower than that during warfarin treatment. The characteristics of intracranial hemorrhage during DOAC therapy, however, remain unclear. Therefore, we performed a nationwide survey in Japan to examine the clinical characteristics and outcomes of DOAC-associated ICH using data obtained from the Japanese Diagnosis Procedure Combination (DPC)-based Payment System. Methods: We analyzed the data of 1,567 patients with ICH (DOAC-associated ICH, 88; warfarin-associated ICH, 1,479) who were urgently hospitalized at 575 institutions across Japan from April 2010 to March 2013 for whom prescription data before admission were available. Results: The annual number of patients with all anticoagulant (DOAC or warfarin)- associated ICH in each year from 2010 to 2013 was 226, 252, 426, and 663, representing 15.7%, 15.4%, 16.1%, and 16.1% of all ICH cases in the same period, respectively. There was an increase in the proportion of patients who presented with DOAC-associated ICH in all anticoagulant-associated ICH in each year from 2010 to 2013 (0%→0.4%→3.8%→10.7%). The proportion of patients with impaired consciousness (three-digit score on Japan Coma Scale) at admission (DOAC, 19.3%; Warfarin, 25.4%; P=0.20), in-hospital mortality within 7 days (DOAC, 11.4%; Warfarin, 19.5%; P=0.06), and mRS score of 5-6 at discharge (DOAC, 27.3%; Warfarin, 37.4%; P=0.06) were lower in the patients with DOAC-associated ICH. The rates of surgery for hematoma removal were significantly lower in the patients with DOAC-associated ICH (NOAC, 2.3%; Warfarin, 9.7%; P=0.019). Conclusions: This is the largest nationwide study of DOAC-associated ICH in a real-world situation in Japan, revealing that the patients with DOAC-associated ICH had better clinical outcomes compared with warfarin-associated ICH, probably due to milder hemorrhage at admission.

Newer and Better? Comparing Direct Oral Anticoagulants to Warfarin in Patients With Traumatic Intracranial Hemorrhage

2020 ◽  
Vol 86 (9) ◽  
pp. 1062-1066
Author(s):  
Joshua D. Billings ◽  
Abid D. Khan ◽  
John H. McVicker ◽  
Thomas J. Schroeppel
Keyword(s):  
Intracranial Hemorrhage ◽  
Injury Severity ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Outcome Data ◽  
Trauma Patients ◽  
Reversal Agents ◽  
Traumatic Intracranial Hemorrhage ◽  
Anticoagulated Patients

Background Direct oral anticoagulants (DOACs) have overtaken warfarin as the preferred anticoagulants for stroke prevention with atrial fibrillation and for treatment of venous thromboembolism. Despite the increased prevalence of DOACs, literature studying their impact on trauma patients with intracranial hemorrhage (ICH) remains limited. Most DOAC reversal agents have only been recently available, and concerns for worse outcomes with DOACs among this population remain. This study aims to assess the outcomes of patients with traumatic ICH taking DOACs compared with those taking warfarin. Methods A retrospective analysis of patients with traumatic ICH over a 5-year period was conducted. Demographics, injury severity, medication, and outcome data were collected for each patient. Patients taking warfarin and DOACs were compared. Results 736 patients had traumatic ICH over the study period, 75 of which were on either DOACs (25 patients) or warfarin (50 patients). The median age of the anticoagulated patients was 78 years; 52% were female, and 91% presented secondary to a fall. DOACs were reversed at close to half the rate of warfarin (40% vs 77%; P = .032). Despite this, the 2 groups had similar rates of worsening examination, need for operative intervention, and in-hospital mortality. In the follow-up, fewer patients taking DOACs had died at 6-months postinjury compared with those taking warfarin (8% vs 30%; P = .041). Discussion Despite DOACs being reversed at nearly half the rate of warfarin, patients presenting with traumatic ICH on warfarin had higher 6-month mortality suggesting a potential survival advantage for DOACs over warfarin in this population.

scholarly journals Reversal Strategies for Intracranial Hemorrhage Related to Direct Oral Anticoagulant Medications

2018 ◽  
Vol 2018 ◽  
pp. 1-11 ◽  
Author(s):  
Alok Dabi ◽  
Aristides P. Koutrouvelis
Keyword(s):  
Side Effects ◽  
Intracranial Hemorrhage ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Factor Xa ◽  
Coagulation Cascade ◽  
Reversal Agents ◽  
United States Food ◽  
Life Threatening

Direct oral anticoagulants (DOACs) are a new class of anticoagulants that directly inhibit either thrombin or factor Xa in the coagulation cascade. They are being increasingly used instead of warfarin or other vitamin K antagonists (VKAs). Adverse side effects of DOACs may result in hemorrhagic complications, including life-threatening intracranial hemorrhage (ICH), though to a much lesser degree than VKAs. Currently there are relatively limited indications for DOACS but their usage is certain to expand with the availability of their respective specific reversal agents. Currently, only idarucizumab (antidote for dabigatran) has been United States Food and Drug Administration- (FDA-) approved, but others (andexanet-α and ciraparantag) may be approved in near future, and the development and availability of such reversal agents have the potential to dramatically change the current anticoagulant use by providing reversal of multiple oral anticoagulants. Until all the DOACs have FDA-approved reversal agents, the treatment of the dreaded side effects of bleeding is challenging. This article is an attempt to provide an overview of the management of hemorrhage, especially ICH, related to DOAC use.

scholarly journals Intracranial hemorrhage in patients taking oral anticoagulants. Current possibilities for therapy

2019 ◽  
Vol 11 (3S) ◽  
pp. 82-88
Author(s):  
S. N. Yanishevsky
Keyword(s):  
Atrial Fibrillation ◽  
Intracranial Hemorrhage ◽  
Vitamin K Antagonists ◽  
Oral Anticoagulants ◽  
Severe Disabilities ◽  
Progression Rate ◽  
Reversal Agents ◽  
Traumatic Intracranial Hemorrhage ◽  
Hypertension Therapy ◽  
Specific Antagonist

The paper reviews an update on the possibilities of providing care for patients with spontaneous non-traumatic intracranial hemorrhage (ICH) developing in patients with atrial fibrillation who use oral anticoagulants. The incidence of ICH is shown to be considerably lower when nonvitamin K-dependent anticoagulants (NOACs) are used, but the hematoma evolution scenarios do not differ between the groups of patients receiving vitamin K antagonists or NOACs. The results of studies assessing hypertension therapy in patients with ICH are compared. The possibilities of using various reversal agents for various oral anticoagulants are also discussed. Since one of the main problems associated with increased mortality and severe disabilities is the progression rate of ICH, the possibility of using a specific antagonist can determine the choice of an anticoagulant for the primary prevention of ischemic stroke in a patient with atrial fibrillation.

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