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The Use of Thromboelastography in Percutaneous Coronary Intervention and Acute Coronary Syndrome in East Asia: A Systematic Literature Review
Xu O, Hartmann J, Tang YD, Dias J
Journal of clinical medicine. 2022;11(13)
Abstract
Dual antiplatelet therapy (DAPT), alongside percutaneous coronary intervention (PCI), is central to the prevention of ischemic events following acute coronary syndrome (ACS). However, response to therapy can vary due to several factors including CYP2C19 gene variation, which shows increased prevalence in East Asian populations. DAPT responsiveness can be assessed using techniques such as light transmission aggregometry (LTA), VerifyNow(®) and thromboelastography with the PlateletMapping(®) assay, and there is increasing focus on the utility of platelet function testing to guide individualized treatment. This systematic literature review of one English and three Chinese language databases was conducted to evaluate the evidence for the utility of thromboelastography in ACS/PCI in East Asia. The search identified 42 articles from the English language and 71 articles from the Chinese language databases which fulfilled the pre-determined inclusion criteria, including 38 randomized controlled trials (RCTs). The identified studies explored the use of thromboelastography compared to LTA and VerifyNow in monitoring patient responsiveness to DAPT, as well as predicting ischemic risk, with some studies suggesting that thromboelastography is better able to detect low DAPT response than LTA. Other studies, including one large RCT, described the use of thromboelastography in guiding the escalation of DAPT, with some evidence suggesting that such protocols reduce ischemic events without increasing the risk of bleeding. There was also evidence suggesting that thromboelastography can be used to identify individuals with DAPT hyporesponsiveness genotypes and could potentially guide treatment by adjusting therapy in patients depending on responsiveness.
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Thromboelastography-Guided Therapy Enhances Patient Blood Management in Cirrhotic Patients: A Meta-analysis Based on Randomized Controlled Trials
Hartmann J, Dias JD, Pivalizza EG, Garcia-Tsao G
Seminars in thrombosis and hemostasis. 2022
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Editor's Choice
Abstract
Patients with cirrhosis often have abnormal hemostasis, with increased risk of hemorrhage and thrombosis. Thromboelastography provides a rapid assessment of the coagulation status and can guide product transfusions in adult patients with cirrhosis. This study aimed to determine whether the use of thromboelastography in adult patients with cirrhosis decreases blood product use and impacts adverse events or mortality compared with standard practice. A registered (PROSPERO CRD42020192458) systematic review and meta-analysis was conducted for randomized controlled trials (RCTs) comparing thromboelastography-guided hemostatic management versus standard practice (control). Co-primary outcomes were the number of transfused platelet units and fresh frozen plasma (FFP) units. Secondary outcomes were mortality, adverse events, utilization of individual blood products, blood loss or excessive bleeding events, hospital/intensive care unit stay, and liver transplant/intervention outcomes. The search identified 260 articles, with five RCTs included in the meta-analysis. Platelet use was five times lower with thromboelastography versus the control, with a relative risk of 0.17 (95% confidence interval [CI]: [0.03-0.90]; p = 0.04), but FFP use did not differ significantly. Thromboelastography was associated with less blood product (p < 0.001), FFP + platelets (p < 0.001), and cryoprecipitate (p < 0.001) use. No differences were reported in bleeding rates or longer term mortality between groups, with the thromboelastography group having lower mortality at 7 days versus the control (relative risk [95% CI] = 0.52 [0.30-0.91]; p = 0.02). Thromboelastography-guided therapy in patients with cirrhosis enhances patient blood management by reducing use of blood products without increasing complications.
PICO Summary
Population
Patients with cirrhosis (5 studies, n= 302).
Intervention
Thromboelastography-guided haemostatic management.
Comparison
Standard coagulation testing (standard practice).
Outcome
Platelet use was five times lower with thromboelastography vs. standard practice, with a relative risk of 0.17 (95% confidence interval [CI]: [0.03-0.90]), but fresh frozen plasma (FFP) use did not differ significantly. Thromboelastography was associated with less blood product, FFP + platelets, and cryoprecipitate use. No differences were reported in bleeding rates or longer-term mortality between groups, with the thromboelastography group having lower mortality at 7 days vs. standard practice (relative risk [95% CI] = 0.52 [0.30-0.91]).
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Use of Thromboelastography in the Evaluation and Management of Patients With Traumatic Brain Injury: A Systematic Review and Meta-Analysis
Cannon JW, Dias JD, Kumar MA, Walsh M, Thomas SG, Cotton BA, Schuster JM, Evans SL, Schreiber MA, Adam EH, et al
Critical care explorations. 2021;3(9):e0526
Abstract
Traumatic brain injury is associated with coagulopathy that increases mortality risk. Viscoelastic hemostatic assays such as thromboelastography (Haemonetics SA, Signy, Switzerland) provide rapid coagulopathy assessment and may be particularly useful for goal-directed treatment of traumatic brain injury patients. We conducted a systematic review to assess thromboelastography in the evaluation and management of coagulopathy in traumatic brain injury patients. DATA SOURCES MEDLINE, PubMed Central, Embase, and CENTRAL. STUDY SELECTION Clinical studies of adult patients with traumatic brain injury (isolated or polytrauma) who were assessed by either standard thromboelastography or thromboelastography with platelet mapping plus either conventional coagulation assays or platelet function assays from January 1999 to June 2021. DATA EXTRACTION Demographics, injury mechanism and severity, diagnostic, laboratory data, therapies, and outcome data were extracted for analysis and comparison. DATA SYNTHESIS Database search revealed 1,169 sources; eight additional articles were identified by the authors. After review, 31 publications were used for qualitative analysis, and of these, 16 were used for quantitative analysis. Qualitative and quantitative analysis found unique patterns of thromboelastography and thromboelastography with platelet mapping parameters in traumatic brain injury patients. Patterns were distinct compared with healthy controls, nontraumatic brain injury trauma patients, and traumatic brain injury subpopulations including those with severe traumatic brain injury or penetrating traumatic brain injury. Abnormal thromboelastography K-time and adenosine diphosphate % inhibition on thromboelastography with platelet mapping are associated with decreased survival after traumatic brain injury. Subgroup meta-analysis of severe traumatic brain injury patients from two randomized controlled trials demonstrated improved survival when using a viscoelastic hemostatic assay-guided resuscitation strategy (odds ratio, 0.39; 95% CI, 0.17-0.91; p = 0.030). CONCLUSIONS Thromboelastography and thromboelastography with platelet mapping characterize coagulopathy patterns in traumatic brain injury patients. Abnormal thromboelastography profiles are associated with poor outcomes. Conversely, treatment protocols designed to normalize abnormal parameters may be associated with improved traumatic brain injury patient outcomes. Current quality of evidence in this population is low; so future efforts should evaluate viscoelastic hemostatic assay-guided hemostatic resuscitation in larger numbers of traumatic brain injury patients with specific focus on those with traumatic brain injury-associated coagulopathy.
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Repeat donation and deferral rates in US source plasma donors: Exploratory analysis from the IMPACT trial
Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, Popovsky MA, Leitman SF
Transfusion. 2021
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Editor's Choice
Abstract
BACKGROUND The IMPACT trial demonstrated the safety of a new personalized nomogram for plasma donation and provided an opportunity to explore short- to mid-term impact on repeat donation and deferral rates, and factors affecting these. STUDY DESIGN AND METHODS In the IMPACT trial, participants were randomized to donate plasma using an established weight-based nomogram (control) versus a new personalized nomogram incorporating height, weight, and hematocrit (experimental). In this exploratory analysis, repeat donations (per donor, by study arm) were analyzed using negative binomial generalized linear regression models and descriptive statistics. The mean number of donor deferral events was compared between the two arms using logistic regression and count data modeling approaches and were analyzed by lead cause. RESULTS The predicted mean number of repeat donations was similar between the control and experimental arms (6.82 vs. 6.62, respectively; p = .22). Overall, the predicted mean number of repeat donations was significantly higher in males compared with females (p < .0001). Naïve donors had on average 2.8/2.7 (control/experimental) fewer repeat donations compared with experienced donors. In 23, 137 donations from 3443 donors, 798 donors (376 control, 422 experimental, p = .80) had at least one deferral (for any cause). The predicted mean number of deferrals in all categories of interest was not statistically different between the study arms. CONCLUSION Similar repeat donation and deferral rates between arms suggest that the new nomogram did not result in disruptions to subsequent donation. Further longitudinal research on mid- to long-term effects is warranted.
PICO Summary
Population
Plasma donors enrolled in the IMPACT trial (n= 3,443).
Intervention
Personalised nomogram incorporating height, weight, and haematocrit (experimental, n= 1,717).
Comparison
Established weight-based nomogram (control, n= 1,726).
Outcome
The predicted mean number of repeat donations was similar between the control and experimental arms (6.82 vs. 6.62). Overall, the predicted mean number of repeat donations was significantly higher in males compared with females. Naïve donors had on average 2.8/2.7 (control/experimental) fewer repeat donations compared with experienced donors. In 23,137 donations from 3,443 donors, 798 donors (376 control, 422 experimental) had at least one deferral. The predicted mean number of deferrals in all categories of interest was not statistically different between the study arms.
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Personalized Collection of Plasma from Healthy Donors: A Randomized Controlled Trial of a Novel Technology-Enabled Nomogram
Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, Popovsky MA, Leitman SF
Transfusion. 2021
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Abstract
BACKGROUND Source plasma is essential to support the growing demand for plasma-derived medicinal products. Supply is short, with donor availability further limited by the COVID-19 pandemic. This study examined whether a novel, personalized, technology-based nomogram was non-inferior with regard to significant hypotensive adverse events (AEs) in healthy donors. STUDY DESIGN AND METHODS IMPACT (IMproving PlasmA CollecTion) was a prospective, multi-center, double-blinded, randomized, controlled trial carried out between January 6 and March 26, 2020 in three U.S. plasma collection centers. Donors were randomized to the current simplified 1992 nomogram (control) or a novel Percent Plasma Nomogram (PPN) with personalized target volume calculation (experimental). Primary endpoint was the rate of significant hypotensive AEs. Non-inferiority (NI) was tested with a margin of 0.15%. Collected plasma volume was a secondary endpoint. RESULTS 3,443 donors (Mean [SD] BMI: 32 (7.74) kg/m(2) ; 65% male) underwent 23,137 donations (Median [range]: 6 [1-22] per subject). Ten significant hypotensive AEs were observed (6 control; 4 experimental), with model-based AE incidence rate estimates (95% CI) of 0.051% (0.020%, 0.114%) and 0.035% (0.010%, 0.094%), respectively (p=0.58). NI was met at an upper limit of 0.043% versus the predefined margin of 0.15%. There was no statistical difference between total AE (all AE types: p=0.32). Mean plasma volume collected was 777.8 mL (control) versus 841.7 mL (experimental); an increase of 63.9 mL per donation (8.2%; p<0.0001). CONCLUSION This trial showed that a novel personalized nomogram approach in healthy donors allowed approximately 8% more plasma per donation to be collected without impairing donor safety. This article is protected by copyright. All rights reserved.
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Thromboelastography-guided therapy improves patient blood management and certain clinical outcomes in elective cardiac and liver surgery and emergency resuscitation: a systematic review and analysis
Dias JD, Sauaia A, Achneck HE, Hartmann J, Moore EE
Journal of thrombosis and haemostasis : JTH. 2019
Abstract
BACKGROUND Thromboelastography (TEG((R)) 5000/6s Thrombelastograph((R)) Hemostasis Analyzer; Haemonetics((R)) , Braintree, MA) is a point-of-care system designed to monitor and analyze the entire coagulation process in real time. TEG((R)) -guided therapy has been shown to be valuable in a variety of surgical settings. OBJECTIVE While guidelines recommend viscoelastic monitoring for the management of perioperative bleeding, there are no meta-analyses specifically evaluating the effects of TEG((R)) -guided transfusion on patient outcomes. PATIENTS/METHODS We searched MEDLINE (PubMed) and EMBASE for original articles using TEG((R)) versus control in a perioperative setting for inclusion in this systematic review. We identified nine eligible randomized controlled trials (RCTs) in two elective surgery settings (cardiac surgery and liver surgery), but only one RCT in the emergency setting. RESULTS In the elective surgery study meta-analysis, platelet (p=0.004), plasma (p<0.001) and red blood cell transfusion (p=0.14), operating room length of stay (LoS) (p=0.005), intensive care unit LoS (p=0.04) and bleeding rate (p=0.002) were reduced with TEG((R)) -guided transfusion versus control. Although blood product use was reduced, rates of mortality remained comparable between TEG((R)) and control groups. In the emergency setting evaluation, the RCT reported lower mortality in the TEG((R)) group versus the controls (p=0.049). In addition, there was a significant reduction in platelet and plasma transfusion (p=0.04 and p=0.02, respectively), and the number of ventilator-free days increased in the TEG((R)) group compared with the controls (p=0.10). CONCLUSIONS This systematic review and analysis indicate that TEG((R)) -guided hemostatic therapy can enhance blood product management and improve key patient outcomes, including LoS, bleeding rate and mortality. This article is protected by copyright. All rights reserved.