PubMed · 15585007
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Jerrold H Levy. 2004. Hemostatic agents.. https://doi.org/10.1111/j.0041-1132.2004.04173.x
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The therapeutic concentration of epsilon-aminocaproic acid (EACA) has been 130 microg/ml or greater for nearly 50 years. We tested the effects on clot growth/disintegration of EACA with a plasmatic model of hyperfibrinolysis in vitro. Human plasma was exposed to 1000 U/ml tissue-type plasminogen activator containing 0, 13, 65 or 130 microg/ml EACA, with clot growth/disintegration kinetics quantified via thrombelastography. Data were analyzed with one-way analysis of variance or Kruskal-Wallis analysis of variance as appropriate. Exposure of plasma to 1000 U/ml tissue-type plasminogen activator resulted in a brief-lived clot, lasting 2 min. EACA at all concentrations tested significantly increased the rate of clot growth compared with samples with 0 microg/ml EACA. Clot strength was significantly increased by EACA in a concentration-dependent fashion. Similarly, EACA significantly prolonged the time of onset of clot lysis and decreased the rate of lysis. Samples with 130 microg/ml EACA had no sign of lysis present for 30 min. Subtherapeutic to therapeutic concentrations of EACA significantly attenuated or abolished fibrinolysis in the presence of a concentration of tissue-type plasminogen activator more than 2000-fold that encountered systemically during cardiopulmonary bypass. Further clinical investigation is warranted to determine whether smaller concentrations of EACA could provide a reduction in bleeding with a concomitant decrease in thrombotic complications.
BACKGROUND: Because primary intracerebral haemorrhage (PICH) volume influences its outcome and a third of PICHs enlarge by a third within 24 hours of onset, early haemostatic drug therapy might improve outcome. OBJECTIVES: To examine the clinical effectiveness and safety of haemostatic drug therapies for acute PICH in a randomised controlled trial (RCT) design. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched May 2006), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2006), MEDLINE (1966 to August 2005) and EMBASE (1980 to August 2005). In an effort to identify further published, ongoing and unpublished studies we scanned bibliographies of relevant articles, searched international registers of clinical trials and research, and contacted authors and pharmaceutical companies. SELECTION CRITERIA: We sought RCTs of any haemostatic drug therapy for acute PICH, compared against placebo or open control, with relevant clinical outcome measures. DATA COLLECTION AND ANALYSIS: Two review authors independently applied the inclusion criteria, reviewed the relevant studies, and extracted data from them. MAIN RESULTS: We found four phase II RCTs, involving adults aged 18 years or over, within four hours of PICH: 116 received placebo and 373 participants received haemostatic drugs (two received epsilon-aminocaproic acid (EACA) and 371 received recombinant activated factor VII (rFVIIa)). Haemostatic drugs appeared to reduce the risk of death or dependence on the modified Rankin Scale (grades 4 to 6) within 90 days of PICH (risk reduction 0.79 (95% confidence intervals (CI) 0.67 to 0.93)), but not when assessed by the extended Glasgow Outcome Scale (risk reduction 0.90 (95%CI 0.81 to 1.01)). There was a statistically significant excess of arterial thromboembolism at 160 mcg/kg rFVIIa. AUTHORS' CONCLUSIONS: Current evidence for the use of haemostatic drugs in the treatment of acute PICH cannot provide clear guidelines for clinical practice. Adults with acute PICH may benefit from haemostatic therapy with rFVIIa, but the evidence on major clinical outcomes is neither robust nor precise. Large phase III RCTs of rFVIIa - and other less costly drugs - are necessary.
The Consensus Document on Alternatives to Allogenic Blood Transfusion (AABT) has been drawn up by a panel of experts from 5 scientific societies. The Spanish Societies of Anesthesiology (SEDAR), Critical Care Medicine and Coronary Units (SEMICYUC), Hematology and Hemotherapy (AEHH), Blood Transfusion (SETS) and Thrombosis and Hemostasis (SETH) have sponsored and participated in this Consensus Document. Alternatives to blood transfusion have been divided into pharmacological and non-pharmacological, with 4 modules and 12 topics. The main objective variable was the reduction of allogenic blood transfusions and/or the number of transfused patients. The extent to which this objective was achieved by each AABT was evaluated using the Delphi method, which classifies the grade of recommendation from A (supported by controlled studies) to E (non-controlled studies and expert opinion). The experts concluded that most of the indications for AABT were based on middle or low grades of recommendation, "C", "D", or "E", thus indicating the need for further controlled studies.