Background
Traumatic brain injury (TBI) is one of the leading causes of disability and death worldwide. Most TBI cases occur in older people, because they are at a higher risk of accidental falling. ...As the population ages, the use of anticoagulants is increasing. Some serious complications of TBI, such as intracranial hemorrhage (ICH), may occur even in mild cases. According to the current guidelines regarding managing mild TBI patients, a CT head scan is recommended for all patients receiving anticoagulation. We aim to assess the incidence of ICH in patients with mild TBI taking oral anticoagulants.
Methods
Our systematic review and meta-analysis were performed using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) checklist. The protocol was registered in PROSPERO (CRD42024503086). Twenty-eight studies evaluating patients with a mild TBI from ten countries with a total sample size of 11,172, 5671 on DOACs, and 5501 on VKAs were included in our meta-analysis.
Results
The random-effects overall incidence of ICH among oral anticoagulated patients with mild TBI was calculated to be 9.4% 95% CI 7.2–12.1%,
I
2
= 89%. The rates of immediate ICH for patients taking DOACs and VKAs were 6.4% and 10.5%, respectively. The overall rate of immediate ICH in anticoagulated mild TBI patients was 8.5% 95% CI 6.6–10.9%, with a high heterogeneity between studies (
I
2
= 88%). Furthermore, the rates of delayed ICH in patients with mild TBI taking DOACs and VKAs were 1.6% and 1.9%, respectively. The overall incidence of delayed ICH among oral anticoagulated mild TBI patients was 1.7% 95% CI 1–2.8%,
I
2
= 79%. The overall rate of ICH among mild TBI patients taking DOAC was calculated to be 7.3% 95% CI 5.2–10.3%, with significant heterogeneity between studies (
I
2
= 79%). However, the overall ICH rate is higher in patients who take only VKAs 11.3% 95% CI 8.6–14.7%,
I
2
= 83%. Patients on DOACs were at lower risk of ICH after mild TBI compared to patients on VKAs (OR = 0.64, 95% CI 0.48–0.86,
p
< 0.01,
I
2
= 28%).
Conclusion
Our meta-analysis confirms the need for performing brain CT scan in patients with mild TBI patients who receive oral anticoagulants before injury. Due to limited data, further multi-center, prospective studies are warranted to confirm the true incidence of traumatic ICH in patients on anticoagulants.
Introduction
Current guidelines recommend that patients with cerebral venous thrombosis (CVT) should be treated with vitamin K antagonists (VKAs) for 3–12 months. Direct oral anticoagulants (DOACs), ...however, are increasingly used in clinical practice. An exploratory randomized controlled trial including 120 patients with CVT suggested that the efficacy and safety profile of dabigatran (a DOAC) is similar to VKAs for the treatment of CVT, but large-scale prospective studies from a real-world setting are lacking.
Methods
DOAC-CVT is an international, prospective, observational cohort study comparing DOACs to VKAs for the prevention of recurrent venous thrombotic events after acute CVT. Patients are eligible if they are 18 years or older, have a radiologically confirmed CVT, and have started oral anticoagulant treatment (DOAC or VKA) within 30 days of CVT diagnosis. Patients with an absolute contra-indication for DOACs, such as pregnancy or severe renal insufficiency, are excluded from the study. We aim to recruit at least 500 patients within a three-year recruitment period. The primary endpoint is a composite of recurrent venous thrombosis and major bleeding at 6 months of follow-up. We will calculate an adjusted odds ratio for the primary endpoint using propensity score inverse probability treatment weighting.
Discussion
DOAC-CVT will provide real-world data on the comparative efficacy and safety of DOACs versus VKAs for the treatment of CVT.
Clinical trial registration
ClinicalTrials.gov
, NCT04660747.
The aim of this work was to conduct a systematic review and meta-analysis of studies reporting on the risk of traumatic intracerebral hemorrhage (tICH), the course of tICH, and its treatment and ...mortality rates in elderly mild traumatic brain injury (mTBI) patients using direct oral anticoagulants (DOACs). We consulted PubMed and Embase for relevant cohort and case-control studies with a control group. Two authors independently selected studies, assessed methodological quality, and extracted outcome data. Estimates were pooled with the Mantel-Haenszel random-effects method. We identified 16 articles comprising 3671 elderly mTBI patients using DOACs. Use of DOACs was associated with a reduced risk of tICH compared to the use of vitamin K antagonists (VKAs; odds ratio OR, 0.44; 95% confidence interval CI, 0.29-0.65; I
= 22%) and a similar risk compared to the use of antiplatelet therapy (APT; OR, 0.98; 95% CI, 0.39-2.44; I
= 0%). Reversal agent use and neurosurgical intervention rate were lower in patients using DOACs compared to patients using VKAs (OR, 0.10; 95% CI, 0.06-0.16; I
= 0% and OR, 0.37; 95% CI, 0.21-0.67; I
= 0%, respectively). There was no significant difference in neurosurgical intervention rate between patients who used DOACs versus patients who used APT (OR, 0.58; 95% CI, 0.15-2.21; I
= 41%) or no antithrombotic therapy (OR, 0.76; 95% CI, 0.20-2.86; I
= 23%). ICH progression, risk of delayed ICH, and TBI-related in-hospital mortality were comparable among treatment groups. The present study indicates that elderly patients using DOACs have a lower risk of adverse outcome compared to patients using VKAs and a similar risk compared to patients using APT after mTBI.
To develop and validate an oral anticoagulant knowledge tool for Chinese-speaking patients treated with warfarin or direct oral anticoagulants (DOACs) in Hong Kong.
This pilot validation study ...consisted of the following three phases: (1) the development of a knowledge tool and content validity assessment; (2) a pilot study of 200 participants, consisting of 100 patients taking warfarin or DOACs, 50 pharmacists, and 50 members of the general public; and (3) known-group validity and reliability assessments.
A 19-item “Chinese Oral Anticoagulants Knowledge Tool (C-OAKT)” was developed with a scale content validity index of 0.95. The mean score for known-group validity was significantly higher in the pharmacist group than the patient groups, and the patient groups scored significantly higher than the general public (mean ± standard deviation SD = 90.00 ± 7.11 vs. 51.55 ± 17.49 vs. 19.0 ± 15.42, respectively; p < 0.001). The mean score was higher for patients who attended a pharmacist-managed anticoagulant therapy management clinic (PAC) than for non-PAC patients (mean ± SD = 56.80 ± 13.60 vs. 46.30 ± 9.43; p = 0.004). An analysis of internal consistency showed a Cronbach's alpha value of 0.86.
The results of the pilot validation study suggested that the C-OAKT is a valid and reliable instrument for assessing patients' knowledge of oral anticoagulants in ambulatory care settings.
This is the first validated Chinese version of an anticoagulant knowledge assessment tool. This tool will be utilized in public hospitals in Hong Kong, and will facilitate future research exploring the relationship between anticoagulant knowledge and patient-related outcomes.
•A Chinese Oral Anticoagulants Knowledge Tool (C-OAKT) is developed and validated.•It is a novel Chinese tool that can be used to assess knowledge of warfarin and DOAC patients.•It demonstrated good known-group validity and internal consistency.
Amiodarone increases exposure of direct oral anticoagulants (DOACs). We aimed to analyze the effects of concurrent amiodarone use on DOAC concentrations and clinical outcomes.
Patients who were ≥20 ...years of age, had atrial fibrillation, and took DOAC were enrolled to provide trough and peak samples for DOAC concentration measurements using ultra-high-performance liquid chromatography-tandem mass spectrometry. The results were compared with concentrations reported in clinical trials to define above, within, or under the expected range. The outcomes of interest were major bleeding and any gastrointestinal bleeding. Multivariate logistic regression and Cox proportional hazards model were used to determine the impact of amiodarone on above-range concentration and clinical outcomes, respectively.
A total of 722 participants (420 men, 58.2%) were enrolled to provide 691 trough samples and 689 peak samples. Among them, 21.3% concurrently used amiodarone. The proportion of patients with above-range trough and peak concentrations was 16.4% and 30.2%, respectively, for amiodarone users, in contrast to 9.4% and 19.8% for amiodarone non-users. The use of amiodarone was associated with above-range trough and peak concentrations (odds ratio OR = 2.00 1.16, 3.47 and 1.82 1.19, 2.79, respectively). However, amiodarone was not a significant predictor of major bleeding or any gastrointestinal bleeding.
Concurrent amiodarone use led to increased DOAC concentration but was not associated with a higher risk of major bleeding or any gastrointestinal bleeding. Therapeutic monitoring of DOAC users concurrently taking amiodarone may be recommended for patients with an additional risk of increased DOAC exposure.
PURPOSE.Results of an investigation of the pharmacodynamic effect of rivaroxaban anticoagulation, as measured by prothrombin time (PT), on bleeding risk and other outcomes in hospitalized patients ...are reported.
METHODS.In a single-center retrospective cohort study, adult inpatients who had a PT measured within 24 hours after rivaroxaban administration during a designated 23-month period were identified. Patients who experienced in-hospital bleeding events were compared with those who did not. A multivariable logistic regression model was used to quantify the association between PT and bleeding events while adjusting for albumin levels and use of nonsteroidal antiinflammatory drugs and/or antiplatelet agents. Thromboembolic events were assessed as a secondary outcome.
RESULTS.A total of 199 patients met the criteria for inclusion in the analysis; 41 experienced a bleeding event. Among patients with a PT of ≥30 seconds versus a PT of <30 seconds, the overall rate of bleeding events was significantly higher (38.7% versus 17.3%, p = 0.0067). Results of multivariable regression modeling showed that a PT of ≥30 seconds correlated with an approximately 3-fold higher bleeding risk (odds ratio, 3.25; 95% confidence interval, 1.09–9.66). Hypoalbuminemia was also a positive predictor of bleeding risk. There was no significant between-group difference in thromboembolic events.
CONCLUSION.In hospitalized patients receiving rivaroxaban who had coagulation tests performed, a PT of ≥30 seconds was associated with a higher risk of bleeding. Hypoalbuminemia was also associated with bleeding in this population.
The post-thrombotic syndrome (PTS) is a frequent, potentially disabling complication of deep vein thrombosis (DVT) that reduces quality of life and is costly. Clinical manifestations include symptoms ...and signs such as leg pain and heaviness, edema, redness, telangiectasia, new varicose veins, hyperpigmentation, skin thickening and in severe cases, leg ulcers. The best way to prevent PTS is to prevent DVT with pharmacologic or mechanical thromboprophylaxis used in high risk patients and settings. In patients whose DVT is treated with a vitamin K antagonist, subtherapeutic INRs should be avoided. We do not suggest routine use of elastic compression stockings (ECS) after DVT to prevent PTS, but in patients with acute DVT-related leg swelling that is bothersome, a trial of ECS is reasonable. We suggest that selecting patients for catheter-directed thrombolytic techniques be done on a case-by-case basis, with a focus on patients with extensive thrombosis, recent symptoms onset, and low bleeding risk, who are seen at experienced hospital centers. For patients with established PTS, we suggest prescribing 20–30 mm Hg knee-length ECS to be worn daily. If ineffective, a stronger pressure stocking can be tried. We suggest that intermittent compression devices or pneumatic compression sleeve units be tried in patients with moderate-to-severe PTS whose symptoms are inadequately controlled with ECS alone. We suggest that a supervised exercise training program for 6 months or more is reasonable for PTS patients who can tolerate it. We suggest that management of post-thrombotic ulcers should involve a multidisciplinary approach. We briefly discuss upper extremity PTS and PTS in children.
Background
Routine monitoring of direct oral anticoagulant (DOAC) levels is not recommended but may be useful in certain clinical situations. There is a knowledge gap regarding the clinical use of ...DOAC levels in Australian hospitals.
Aims
To evaluate the clinical settings, indications and changes to anticoagulant management associated with DOAC levels in a tertiary hospital in Northern Tasmania, Australia.
Methods
Patients with one or more DOAC levels (dabigatran, rivaroxaban or apixaban) requested between January 2017 and December 2022 were identified. Retrospective chart review was performed to evaluate the clinical settings, indications, adequacy of request information and changes to clinical management associated with the measurement of DOAC levels.
Results
One hundred and twenty‐nine DOAC measurements (54 rivaroxaban, 66 apixaban and nine dabigatran) were performed in 98 patients between January 2017 and December 2022. Annual requests for DOAC levels increased significantly between 2017 and 2019 and remained stable between 2020 and 2021 but declined in 2022. Overall, the most common indication for a DOAC level was renal impairment, followed by bleeding and recurrent thrombosis. Approximately 25% of requests were for acute bleeding with a reversal/haemostatic agent given in 45% of patients, while 10% were prior to urgent surgery. Measurement of DOAC levels was associated with a change in management in 50% of cases. 10% of requests did not specify anticoagulant history.
Conclusion
Trends in requests for DOAC levels have changed over time. Clinician education regarding the importance of providing specific anticoagulant history is essential. Future prospective studies investigating the clinical utility of DOAC levels in different clinical settings are needed.
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