METHODS: An electronic search was performed via PubMed, SCOPUS, Google Scholar, and Cochrane from inception to June 2022. The included trials were evaluated according to the recommendations of the Cochrane Handbook for Systematic Reviews. The primary outcome assessed was the intraoperative bleeding score of the surgical field. The mean arterial pressure, duration of the surgery, amount of blood loss and surgeon's satisfaction score were assessed as the secondary outcomes. The risk of bias for each study was evaluated using the Cochrane risk of bias tool.
RESULTS: A total of 254 records were identified after removal of duplicates. Based on the title and abstract 246 records were excluded, leaving seven full texts for further consideration. Five records were excluded following full text assessment. Three trials with a total of 212 patients were selected. Hot saline irrigation was superior to control in the intraoperative bleeding score (MD - 0.51, 95% CI - 0.84 to - 0.18; P < 0.001; I2 = 72%; very low quality of evidence) and surgeon's satisfaction score (RR 0.18, 95% CI 0.09 to 0.33; P < 0.001; I2 = 0%; low quality of evidence). The duration of surgery was lengthier in control when compared to HSI (MD - 9.02, 95% CI - 11.76 to - 6.28; P < 0.001; I2 = 0; very low quality of evidence). The volume of blood loss was greater in control than HSI (MD - 56.4, 95% CI - 57.30 to - 55.51; P < 0.001; I2 = 0%; low quality of evidence). No significant difference between the two groups for the mean arterial pressure was noted (MD - 0.60, 95% CI - 2.17 to 0.97; P = 0.45; I2 = 0%; low quality of evidence).
CONCLUSIONS: The practice of intranasal HSI during ESS is favorable in controlling intraoperative bleeding and improving the surgical field quality. It increases the surgeon's satisfaction, reduces blood loss, shortens operative time and has no effect on intraoperative hemodynamic instability.
TRIAL REGISTRATION: PROSPERO registration number: CRD42019117083.
METHODS: We prospectively analyzed the use of FloSeal with a hemostatic delivery system in transnasal endoscopic and microscopic skull base procedures performed at the authors' institution from January 1, 2015, to June 30, 2015. In all cases the number of aliquots was noted for the entire operation, and the total number of FloSeal ampules of 5 mL was also recorded.
RESULTS: Our device allowed controlled application of small amounts (0.5-1 mL) of FloSeal to the site of bleeding. This controlled application resulted not only in increased visibility during its application, but it also reduced the amount of FloSeal required during the procedure. We were able to use 5-10 applications per 5-mL ampule of FloSeal within an individual procedure. No procedure required more than one 5-mL ampule of FloSeal. Therefore, the use of our device results in a reduction of costs. Prior to the use of our device, we were often only able to use 1 vial of 5 ml of material for 1 or 2 applications, especially in transnasal endoscopic procedures when working along a deep corridor.
CONCLUSIONS: Our results indicate that our delivery device of FlowSeal can effectively control hemostasis by applying small amounts of FlowSeal to the site of bleeding. This results in increased visibility during hemostasis and a reduction of cost.
OBJECTIVES: The primary aim of this review was to investigate the effect of fibrinogen concentrate in postoperative blood loss in adult surgical patients.
DESIGN: Systematic review and meta-analysis.
DATA SOURCES: Databases of MEDLINE, EMBASE and CENTRAL were searched from their start date until July 2019.
ELIGIBILITY CRITERIA: All randomized clinical trials comparing intravenous fibrinogen concentrate and placebo in adult surgical patients were included, regardless of type of surgery. Observational studies, case reports, case series and non-systematic reviews were excluded.
RESULTS: Thirteen trials (n = 900) were included in this review. In comparison to placebo, fibrinogen concentrate significantly reduced the first 12-hour postoperative blood loss, with a mean difference of -134.6 ml (95% CI -181.9 to -87.4). It also significantly increased clot firmness in thromboelastometry (FIBTEM) with a mean difference of 2.5 mm (95%CI 1.1 to 3.8). No significant differences were demonstrated in the adverse events associated with fibrinogen concentrate use, namely incidence of thromboembolism, myocardial infarction and acute kidney injury.
CONCLUSIONS: In this meta-analysis of 13 randomized trials, low level of evidence and substantial heterogeneity with small sample size limit strong recommendation on the use of fibrinogen concentrate in adult surgical patients. However, its use is tolerable without any notable adverse events.
TRIAL REGISTRATION: CRD42019149164.
METHODS: Patients chose to continue treatment with nonacog beta pegol in either one of two once-weekly prophylaxis arms (10IU/kg or 40IU/kg), or an on-demand arm (40IU/kg for mild/moderate bleeds; 80IU/kg for severe bleeds). The primary objective was to evaluate immunogenicity; key secondary objectives included assessing safety and haemostatic efficacy in the treatment and prevention of bleeds.
RESULTS: Seventy-one patients received prophylaxis or on-demand treatment. No patient developed an inhibitor and no safety concerns were identified. The success rate for the treatment of reported bleeds was 94.6%; most (87.9%) resolved with one injection. The median annualised bleeding rate for patients on prophylaxis was 1.36 (interquartile range [IQR] 0.00-2.23) and 1.00 (IQR 0.00-2.03) for the 10 and 40IU/kg treatment arms, respectively. The mean FIX activity trough achieved for 10 and 40IU once weekly was 9.8% and 21.3%, respectively. Fourteen patients on prophylaxis underwent 23 minor surgical procedures; haemostatic perioperative outcomes for all of those evaluated were 'excellent' or 'good'.
CONCLUSIONS: Nonacog beta pegol showed a favourable tolerability profile (with no safety issues identified) with good prophylactic protection and control of bleeding in previously treated adult and adolescent haemophilia B patients.
Method: We searched MEDLINE, EMBASE, CENTRAL and clinical trial registers for studies using search strategies incorporating the terms 'intracerebral haemorrhage', 'tranexamic acid' and 'antifibrinolytic'. Authors of ongoing clinical trials were contacted for further details.
Findings: We screened 268 publications and retrieved 17 articles after screening. Unpublished information from three ongoing clinical trials was obtained. We found five completed studies. Of these, two randomised controlled trials (RCTs) comparing intravenous tranexamic acid to placebo (n = 54) reported no significant difference in death or dependency. Three observational studies (n = 281) suggested less haematoma growth with rapid tranexamic acid infusion. There are six ongoing RCTs (n = 3089) with different clinical exclusions, imaging selection criteria (spot sign and haematoma volume), time window for recruitment and dosing of tranexamic acid.
Discussion: Despite their heterogeneity, the ongoing trials will provide key evidence on the effects of tranexamic acid on ICH. There are uncertainties of whether patients with negative spot sign, large haematoma, intraventricular haemorrhage, or poor Glasgow Coma Scale should be recruited. The time window for optimal effect of haemostatic therapy in ICH is yet to be established.
Conclusion: Tranexamic acid is a promising haemostatic agent for ICH. We await the results of the trials before definite conclusions can be drawn.
Methods: Cirrhotic patients with suspected EVB were screened (n = 352). Eligible patients were assigned based on the physician's preference to either somatostatin (group S) or terlipressin (group T) followed by EVL. In group S, intravenous bolus (250 µg) of somatostatin followed by 250 µg/hour was continued for three days. In group T, 2 mg bolus injection of terlipressin was followed by 1 mg infusion every 6 h for three days.
Results: A total of 150 patients were enrolled; 41 in group S and 109 in group T. Reasons for physician preference was convenience in administration (77.1%) for group T and good safety profile (73.2%) for group S. Very early rebleeding within 49-120 h occurred in one patient in groups S and T (p = 0.469). Four patients in group S and 14 patients in group T have variceal rebleeding episodes within 6-42 d (p = 0.781). Overall treatment-related adverse effects were compatible in groups S and T (p = 0.878), but the total cost of terlipressin and somatostatin differed i.e., USD 621.32 and USD 496.43 respectively.
Conclusions: Terlipressin is the preferred vasoactive agent by physicians in our institution for acute EVB. Convenience in administration and safety profile are main considerations of physicians. Safety and hemostatic effects did not differ significantly between short-course somatostatin or terlipressin, although terlipressin is more expensive.