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  • 1
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    Efficacy and safety of iloprost in trauma patients with haemorrhagic shock‐induced endotheliopathy—Protocol for the multicentre randomized, placebo‐controlled, blinded, investigator‐initiated shine‐trauma trial
    Wiley ; 2021
    In:  Acta Anaesthesiologica Scandinavica Vol. 65, No. 4 ( 2021-04), p. 551-557
    Details
    In: Acta Anaesthesiologica Scandinavica, Wiley, Vol. 65, No. 4 ( 2021-04), p. 551-557
    Abstract: Traumatic injury accounts for 800 000 deaths in the European Union annually. The main causes of deaths in trauma patients are exsanguination and multiple organ failure (MOF). We have studied 〉 1000 trauma patients and identified shock‐induced endotheliopathy (SHINE), the pathophysiological mechanism responsible for MOF and high mortality. Pilot studies indicate that low‐dose iloprost (1 ng/kg/min) improves endothelial functionality in critically ill patients suggesting this intervention may improve patient outcome in traumatic SHINE. Material and Methods This is a multicentre, randomized, blinded clinical investigator‐initiated phase 2B trial in trauma patients with haemorrhagic shock‐induced endotheliopathy. Patients are randomized 1:1 to 72 hours infusion of iloprost 1 ng/kg/min or Placebo (equal volume of saline). A total of 220 trauma patients will be included. The primary endpoint is the number of intensive care unit (ICU)‐free days, within 28 days of admission. Secondary endpoints include 28‐ and 90‐day all‐cause mortality, hospital length of stay, vasopressor‐free days in the intensive care unit (ICU) within 28 days, ventilator‐free days in the ICU within 28 days, renal replacement‐free days in the ICU within 28 days, number of serious adverse reactions and serious adverse events within the first 4 days of admission. Discussion This trial will test the safety and efficacy of administration of iloprost vs placebo for 72 hours in trauma patients with haemorrhagic shock‐induced endotheliopathy. Trial endpoints focus on the potential effect of iloprost to reduce the need for ICU stay secondary to mitigation of organ failure. Trial registration SHINE‐TRAUMA trial—EudraCT no. 2019‐000936‐24—Clinicaltrials.gov: NCT03903939 Ethics Committee no. H‐19014482.
    Type of Medium: Online Resource
    ISSN: 0001-5172 , 1399-6576
    URL: Issue
    URL: Article
    DOI: 10.1111/aas.v65.4
    DOI: 10.1111/aas.13776
    RVK:
    XA 11250
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2004319-3
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  • 2
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    Prehospital Transfusion of Red Blood Cells and Plasma by an Urban Ground-Based Critical Care Team
    Cambridge University Press (CUP) ; 2021
    In:  Prehospital and Disaster Medicine Vol. 36, No. 2 ( 2021-04), p. 170-174
    Details
    In: Prehospital and Disaster Medicine, Cambridge University Press (CUP), Vol. 36, No. 2 ( 2021-04), p. 170-174
    Abstract: Prehospital blood component therapy poses a possible treatment option among patients with severe bleeding. The aim of this paper was to characterize patients receiving prehospital blood component therapy by a paramedic-doctor-staffed, ground-based prehospital critical care (PHCC) service. Methods: Bleeding patients with a clinical need for prehospital blood transfusion were included prospectively. The following data were collected: indication for transfusion, mechanism of injury, vital parameters, units of red blood cells (RBCs)/plasma transfused, degree of shock, demographics, and mortality. Results: Twenty-one patients received blood products: 12 (57%) traumatic injuries and nine (43%) non-traumatic bleeds, with a median of 1.5 (range 1.0-2.0) units of RBCs and 1.0 (range 0.0-2.0) unit of plasma. The most frequent trigger to initiate transfusion was on-going excessive bleeding and hypotension. Improved systolic blood pressure (SBP) and milder degrees of shock were observed after transfusion. Mean time from initiation of transfusion to hospital arrival was 24 minutes. In-hospital, 11 patients (61%) received further transfusion and 13 (72%) had urgent surgery within 24 hours. Overall, 28-day mortality was 29% at 24-hours and 33% at 28-days. Conclusion: Prehospital blood component therapy is feasible in a ground-based prehospital service in a medium-sized Scandinavian city. Following transfusion, patient physiology and degree of shock were significantly improved.
    Type of Medium: Online Resource
    ISSN: 1049-023X , 1945-1938
    URL: Article
    DOI: 10.1017/S1049023X20001491
    Language: English
    Publisher: Cambridge University Press (CUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2162069-6
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  • 3
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    Prostacyclin in trauma patients with hemorrhagic shock: A randomized clinical trial
    Ovid Technologies (Wolters Kluwer Health) ; 2024
    In:  Journal of Trauma and Acute Care Surgery Vol. 96, No. 3 ( 2024-3), p. 476-481
    Details
    In: Journal of Trauma and Acute Care Surgery, Ovid Technologies (Wolters Kluwer Health), Vol. 96, No. 3 ( 2024-3), p. 476-481
    Abstract: A main cause of trauma morbidity and mortality is multiple-organ failure, and endotheliopathy has been implicated. Pilot studies indicate that low-dose prostacyclin improves endothelial functionality in critically ill patients, suggesting that this intervention may improve trauma patient outcome. METHODS We conducted a multicenter, randomized, blinded, clinical investigator-initiated trial in 229 trauma patients with hemorrhagic shock who were randomized 1:1 to 72 hours infusion of the prostacyclin analog iloprost (1 ng/kg/min) or placebo. The primary outcome was the number of intensive care unit (ICU)–free days alive within 28 days of admission. Secondary outcomes included 28-day all-cause mortality and hospital length of stay. RESULTS The mean number of ICU-free days alive within 28 days was 15.64 days in the iloprost group versus 13.99 days in the placebo group (adjusted mean difference, −1.63 days [95% confidence interval (CI), −4.64 to 1.38 days]; p = 0.28). The 28-day mortality was 18.8% in the iloprost group versus 19.6% in the placebo group (odds ratio, 1.01 [95% CI, 0.51–2.0]; p = 0.97). The mean hospital length of stay was 19.96 days in the iloprost group versus 27.32 days in the placebo group (adjusted mean difference, 7.84 days [95% CI, 1.66–14.02 days], p = 0.01). CONCLUSION Iloprost did not result in a statistically significant increase in the number of ICU-free days alive within 28 days of admission, whereas it was safe and a statistically significant reduction in hospital length of stay was observed. Further research on prostacyclin in shocked trauma patients is warranted. LEVEL OF EVIDENCE Therapeutic/Care Management; Level II.
    Type of Medium: Online Resource
    ISSN: 2163-0763 , 2163-0755
    URL: Article
    DOI: 10.1097/TA.0000000000004150
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2024
    detail.hit.zdb_id: 2651313-4
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  • 4
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    Impaired fibrinolysis and increased clot strength are potential risk factors for thrombosis in lymphoma
    American Society of Hematology ; 2023
    In:  Blood Advances
    Details
    In: Blood Advances, American Society of Hematology
    Abstract: Thrombosis and bleeding are significant contributors to morbidity and mortality in patients with hematological cancer, and the impact of altered fibrinolysis on bleeding and thrombosis risk is poorly understood. In this prospective cohort study, we investigated the dynamics of fibrinolysis in hematological cancer patients. Fibrinolysis was investigated prior to treatment and three months after treatment initiation. A dynamic clot formation and lysis assay was performed beyond the measurement of plasminogen activator inhibitor 1, tissue- and urokinase-type plasminogen activators (tPA and uPA), plasmin-antiplasmin complexes (PAP), α-2-antiplasmin activity, and plasminogen activity. Clot initiation, clot propagation, and clot strength were assessed using thromboelastometry (ROTEM®). A total of 79 patients were enrolled. Lymphoma patients displayed impaired fibrinolysis with prolonged 50% clot lysis time compared to healthy controls (p = 0.048). They also displayed decreased clot strength at follow-up compared to at diagnosisp (p = 0.001). A patient with amyloid-light-chain amyloidosis having overt bleeding at diagnosis displayed hyperfibrinolysis, indicated by a reduced 50% clot lysis time, α-2-antiplasmin activity, and plasminogen activity and elevated tPA and uPA. A patient with acute promyelocytic leukemia also displayed marked hyperfibrinolysis with very high PAP indicating extreme plasmin generation, and clot formation was not measurable probably due to the extremely fast fibrinolysis. Fibrinolysis returned to normal after treatment in both patients. In conclusion, lymphoma patients showed signs of impaired fibrinolysis and increased clot strength, whereas hyperfibrinolysis was seen in patients with acute promyelocytic leukemia and light-chain amyloidosis. Thus, investigating fibrinolysis in hematological cancer patients could have diagnostic value.
    Type of Medium: Online Resource
    ISSN: 2473-9529 , 2473-9537
    URL: Article
    DOI: 10.1182/bloodadvances.2023011379
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2023
    detail.hit.zdb_id: 2876449-3
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  • 5
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    Prophylaxis with low dose tranexamic acid in acute myeloid leukemia patients undergoing intensive chemotherapy
    Wiley ; 2023
    In:  eJHaem Vol. 4, No. 3 ( 2023-08), p. 690-694
    Details
    In: eJHaem, Wiley, Vol. 4, No. 3 ( 2023-08), p. 690-694
    Abstract: Patients suffering from acute myeloid leukemia (AML) carry a high risk of serious bleeding complications due to severe thrombocytopenia for long periods of time during treatment. Prior to prophylactic platelet transfusion becoming the standard of care, intracranial bleeding was a major contributor to death in AML patients. However, despite prophylactic platelet transfusions, up to 79% of patients with AML experience clinically significant bleeding during treatment. Antifibrinolytics are effective and well tolerated hemostatic agents widely used in many patient groups, and in this study, we investigated the effect of low dose tranexamic acid (TXA) in patients with AML and thrombocytopenia. We compared bleeding and thrombosis between 113 thrombocytopenic AML patients receiving TXA 500 mg three times daily ( n  = 36) versus no‐TXA ( n  = 77). Clinical information was obtained systematically from electronic medical records, and laboratory data were collected from the laboratory information system. No difference was demonstrated in number of patients with at least one bleeding episode (TXA: 89% vs. no‐TXA: 93%, p  = 0.60), median number of bleeding days (TXA: 2.5 days vs. no‐TXA 2.0 days, p = 0.30), bleeding location or transfusion needs between the two groups. However, platelet count was found to be a significant risk factor for bleeding, with a probability of bleeding of 35% with a platelet count below 5 × 10 9 /L (logistic regression, p   〈  0.01). We found no difference in thromboembolic events between the two groups (TXA: 8% vs. no‐TXA 10%, p  = 0.99). In conclusion, treatment with low dose TXA is safe, but we found no evidence to suggest that it reduces bleeding in AML patients with thrombocytopenia.
    Type of Medium: Online Resource
    ISSN: 2688-6146 , 2688-6146
    URL: Issue
    URL: Article
    DOI: 10.1002/jha2.v4.3
    DOI: 10.1002/jha2.699
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 3021452-X
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  • 6
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    Comparing restrictive versus liberal oxygen strategies for trauma patients — the TRAUMOX2 trial: protocol for a randomised clinical trial
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 11 ( 2022-11), p. e064047-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 11 ( 2022-11), p. e064047-
    Abstract: Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma. Methods and analysis TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial. Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen ( 〉 21%) that ensures an SpO 2 of 94%. The liberal group receives 12–15 L O 2 /min or FiO 2 =0.6–1.0. The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group. Ethics and dissemination TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website ( www.traumox2.org ) is available for updates and study results will be published in an international peer-reviewed scientific journal. Trial registration numbers EudraCT 2021-000556-19; NCT05146700 .
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    URL: Article
    DOI: 10.1136/bmjopen-2022-064047
    DOI: 10.1136/bmjopen-2022-064047.supp1
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2599832-8
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  • 7
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    Perioperative Coagulation Monitoring
    Elsevier BV ; 2021
    In:  Anesthesiology Clinics Vol. 39, No. 3 ( 2021-09), p. 525-535
    Details
    In: Anesthesiology Clinics, Elsevier BV, Vol. 39, No. 3 ( 2021-09), p. 525-535
    Type of Medium: Online Resource
    ISSN: 1932-2275
    URL: Article
    DOI: 10.1016/j.anclin.2021.03.010
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2021
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  • 8
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    Effect of Tranexamic Acid on Coagulation and Fibrin Clot Properties in Children Undergoing Craniofacial Surgery
    Georg Thieme Verlag KG ; 2020
    In:  Thrombosis and Haemostasis Vol. 120, No. 03 ( 2020-03), p. 392-399
    Details
    In: Thrombosis and Haemostasis, Georg Thieme Verlag KG, Vol. 120, No. 03 ( 2020-03), p. 392-399
    Abstract: Objective Craniosynostosis surgery in small children is very often associated with a high blood loss. Tranexamic acid (TXA) reduces blood loss during this procedure, although the potential underlying coagulopathy in these children is not known in detail. Objective was to determine the nature of any coagulopathy found during and after craniosynostosis surgery and to characterize the effect of TXA on fibrin clot formation, clot strength, and fibrinolysis. Materials and Methods Thirty children received either TXA (bolus dose of 10 mg/kg followed by 8 hours continuous infusion of 3 mg/kg/h) or placebo. Dynamic whole blood clot formation assessed by thromboelastometry, platelet count, dynamic thrombin generation/thrombin-antithrombin, clot lysis assay, and fibrinogen/factor XIII (FXIII) levels were measured. Additionally, clot structure was investigated by real-time live confocal microscopy and topical data analysis. Results Increased ability of thrombin generation was observed together with a tendency toward shortened activated partial thromboplastin time and clotting time. Postoperative maximum clot firmness was higher among children receiving TXA. FXIII decreased significantly during surgery in both groups. Resistance toward tissue plasminogen activator-induced fibrinolysis was higher in children that received TXA, as evidenced by topical data analysis and by a significant longer lysis time. Fibrinogen levels were higher in the TXA group at 24 hours. Conclusion A significant coagulopathy mainly characterized by changes in clot stability and not parameters of thrombin generation was reported. Tranexamic acid improved clot strength and reduced fibrinolysis, thereby avoiding reduction in fibrinogen levels.
    Type of Medium: Online Resource
    ISSN: 0340-6245 , 2567-689X
    URL: Article
    DOI: 10.1055/s-0039-3402762
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2020
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  • 9
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    Efficacy and Safety of Antifibrinolytic Drugs in Pediatric Surgery: A Systematic Review
    Georg Thieme Verlag KG ; 2021
    In:  Seminars in Thrombosis and Hemostasis Vol. 47, No. 05 ( 2021-07), p. 538-568
    Details
    In: Seminars in Thrombosis and Hemostasis, Georg Thieme Verlag KG, Vol. 47, No. 05 ( 2021-07), p. 538-568
    Abstract: Antifibrinolytic drugs are used to reduce blood loss and subsequent transfusions during surgery and following trauma, but the optimal dosing regimen in the pediatric population is still unresolved. The aim of this systematic review was to evaluate efficacy and safety of antifibrinolytic drugs in pediatric surgery and trauma to determine the optimal dosing regimen. A literature search was performed in PubMed, Embase, Cochrane, and Web of Science on May 3, 2020. We included randomized controlled studies investigating the effect of tranexamic acid (TXA), aprotinin, and epsilon-aminocaproic acid, in terms of reducing blood loss, blood transfusions, reoperations, and rebleeds in pediatric patients aged 0 to 18 years undergoing cardiac surgery, noncardiac surgery, or trauma. Fifty randomized controlled trials (RCTs) were included; 28 RCTs investigated cardiac surgery and 22 investigated noncardiac surgery. No RCTs regarding trauma met the inclusion criteria. All antifibrinolytic drugs reduced postoperative blood loss and transfusions when used in pediatric surgery. The dosing regimen varied between studies, but similar effect sizes were found in terms of reduced blood loss regardless of the cumulative dose used. Few studies found adverse events, and no difference in incidence or type of adverse events was seen between the antifibrinolytic and the placebo group. In conclusion, use of antifibrinolytics is efficient and safe in children undergoing surgery. We propose TXA as the drug of choice based on its level of evidence and safety profile; we recommend a dosing regimen composed of a loading dose of 10 to 15 mg/kg prior to surgery followed by 1 to 5 mg/kg/h as continuous infusion throughout surgery.
    Type of Medium: Online Resource
    ISSN: 0094-6176 , 1098-9064
    URL: Article
    DOI: 10.1055/s-0040-1721736
    Language: English
    Publisher: Georg Thieme Verlag KG
    Publication Date: 2021
    detail.hit.zdb_id: 2072469-X
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  • 10
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    Effect of tranexamic acid on markers of inflammation in children undergoing craniofacial surgery
    Wiley ; 2021
    In:  Acta Anaesthesiologica Scandinavica Vol. 65, No. 1 ( 2021-01), p. 34-39
    Details
    In: Acta Anaesthesiologica Scandinavica, Wiley, Vol. 65, No. 1 ( 2021-01), p. 34-39
    Abstract: Tranexamic acid (TXA) reduces blood loss and transfusion requirements during craniosynostosis surgery in small children. Possible interaction from TXA on the inflammatory system is unknown. Objective To evaluate the effect of TXA on a wide range of inflammatory markers in children receiving TXA in a randomized, blinded, and placebo controlled study design. Methods Thirty children undergoing craniosynostosis surgery with significant blood loss received TXA (bolus dose of 10 mg kg −1 followed by 8 hours continuous infusion of 3 mg kg −1  h −1 ) or placebo in a randomized, double‐blinded study design. Using a new proximity extension assays employing a panel of inflammatory biomarkers samples was used for analysis of blood samples obtained pre‐operatively, 4 and 24 hours after operation. Results Ninety‐two inflammatory parameters were measured. TXA did not affect any of the measured parameters as compared with placebo. Among 34 of the 92 pro‐ and antiinflammatory parameters investigated changes were observed between pre‐operative, 4 or 24 hours, respectively, reflecting immune activation during surgical stress. Conclusion TXA administration in a low‐dose regimen including bolus followed by 8 hours infusion during craniosynostosis surgery did not change any of 92 inflammatory markers as compared with placebo.
    Type of Medium: Online Resource
    ISSN: 0001-5172 , 1399-6576
    URL: Issue
    URL: Article
    DOI: 10.1111/aas.v65.1
    DOI: 10.1111/aas.13700
    RVK:
    XA 11250
    Language: English
    Publisher: Wiley
    Publication Date: 2021
    detail.hit.zdb_id: 2004319-3
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