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Bleeding Rates (bleeding + rate)
Selected AbstractsReformulated BeneFix®: efficacy and safety in previously treated patients with moderately severe to severe haemophilia BHAEMOPHILIA, Issue 3 2007T. LAMBERT Summary. BeneFix®, the only recombinant factor IX (FIX), has been reformulated. The reformulation involves a change in diluent and allows for more concentrated infusions of recombinant FIX. A double-blind, randomized, pharmacokinetic (PK) crossover study demonstrated that reformulated BeneFix was bioequivalent to original BeneFix and follow-up PK evaluation after 6 months of treatment demonstrated the PK stability of reformulated BeneFix after multiple exposures. Favourable efficacy and safety profiles, consistent with those already well-established for original BeneFix, were observed: 81.1% of haemorrhages resolved with only a single infusion; 85.3% of initial treatment response ratings were Excellent or Good; more than half of the subjects using reformulated BeneFix for routine prophylaxis (11 of 17, 64.7%) had no spontaneous haemorrhages during their 6,12 month course of prophylactic treatment, with an overall spontaneous bleeding rate of 0.72 year,1; and for the single surgical procedure (knee washing), treatment was rated Useful. In addition, there was no FIX inhibitor development, allergic-type manifestations, or thrombogenic complications with more than 1100 infusions (nearly 5.2 million IUs) administered in this trial. All efficacy and safety outcomes from this study were achieved with more concentrated recombinant protein infusions than that possible with original BeneFix, and utilization of the 2000 IU per vial dosage strength, newly introduced with the reformulated product, was high (>62%). The reformulation of BeneFix allows smaller delivery volumes and an increased choice of dosage strengths without altering the PK properties (including incremental recovery and half-life) or the established efficacy and safety profile of recombinant FIX. [source] Effects of tibolone and continuous combined hormone replacement therapy on bleeding rates, quality of life and tolerability in postmenopausal womenBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 8 2002J. Huber Objective To compare the effects of tibolone and conjugated equine oestrogens continuously combined with medroxyprogesterone acetate on bleeding rates, quality of life (QoL) and tolerability. Design A double-blind, randomised comparative trial. Setting Thirty-seven centres in six European countries. Population Five hundred and one postmenopausal women, under 65 years of age with an intact uterus. Interventions For 12 months, women received daily treatment with tibolone 2.5 mg (n= 250), or conjugated equine oestrogens 0.625 mg continuously combined with medroxyprogesterone acetate 5 mg (CEE,MPA, n= 251). Main outcome measures The primary outcome was vaginal bleeding rate during cycles 4,6. The secondary outcomes were vaginal bleeding rate during cycles 1,3, 7,9 and 10,13, cumulative bleeding rate, QoL, wellbeing, climacteric symptoms, urogenital complaints and tolerability. Results Treatment with tibolone led to a significantly lower bleeding rate during cycles 4,6 compared with CEE,MPA (15.0%vs 26.9%; P= 0.004); there was a similar difference during cycles 1,3. Both treatments improved QoL, wellbeing, climacteric symptoms and urogenital complaints. By intent-to-treat analysis, tibolone significantly improved sexual drive, interest and/or performance, compared with CEE,MPA at 12 months (P= 0.017). Although both treatments were well tolerated, there was a significantly lower incidence of breast tenderness with tibolone than CEE,MPA (2.4%vs 17.1%; P < 0.001). Conclusion The vaginal bleeding rate during cycles 4,6 was significantly lower in women using tibolone. Both treatments improved QoL, wellbeing, climacteric symptoms and urogenital symptoms. Breast tenderness was significantly less frequent with tibolone. [source] 70 vs 120 W thulium:yttrium-aluminium-garnet 2 µm continuous-wave laser for the treatment of benign prostatic hyperplasia: a systematic ex-vivo evaluationBJU INTERNATIONAL, Issue 3 2010Thorsten Bach Study Type , Aetiology (case series) Level of Evidence 4 OBJECTIVE To evaluate the ablative and haemostatic properties of the recently introduced 120-W thulium:yttrium-aluminium-garnet (Tm-YAG) laser and to assess these results against those of the previously introduced 70-W Tm-YAG laser. MATERIALS AND METHODS The ex-vivo model of the isolated blood-perfused porcine kidney was used to determine the ablation capacity, haemostatic properties and coagulation depth of a 2 µm continuous-wave Tm-YAG laser. The energy was delivered using a 550-µm and an 800-µm bare-ended fibre. The results of the recently introduced 120-W Tm-YAG were compared to the established 70-W device. Kidney tissue was embedded for histological evaluation. After staining (haematoxylin and eosin, H&E; and NADH) of the specimen, the coagulation zone and depth of the necrotic tissue layer were measured. RESULTS With increased power output, the mean (sd) rate of vaporization of tissue increased, from 9.80 (3.03) g/10 min at 70 W to 16.41 (5.2) g/10 min at 120 W using the 550 µm fibre. The total amount of ablated tissue using the 800 µm fibre was lower than with the 550 µm fibre. With increasing power output the bleeding rate remained stable in either group. Tissue penetration remained shallow, even with increasing power output. In contrast to H&E staining, where the coagulation zone was measured, NADH staining showed an inner zone of necrotic tissue, again with no difference between the 70- and the 120-W Tm-YAG. CONCLUSION The 120-W Tm-YAG offers significantly higher ablation rates than the 70-W device, and despite the increased rate of ablation with the 120-W Tm-YAG, the bleeding rate and depth of tissue penetration were comparable to those using the 70-W device. [source] Can circle hook use benefit billfishes?FISH AND FISHERIES, Issue 2 2009Joseph E Serafy Abstract We performed a quantitative review to evaluate circle hook use in recreational and commercial hook-and-line fisheries that interact with billfishes (Family: Istiophoridae). Specifically, we scrutinized the findings of 11 recent empirical studies that reported, on a species-specific basis, side-by-side measures of circle vs. J-hook fishing performance: catch, mortality, deep-hooking and bleeding rates. Of the 30 total comparisons extracted from the literature that satisfied our inclusion criteria, 13 indicated significant differences between hook types for the specific metric compared. No study reported significant billfish catch rate differences between hook types. However, when significant differences between hook types were found, higher mortality rates and higher rates of deep-hooking and bleeding were associated with J-hooks relative to circle hooks. We conclude that empirical evidence is sufficient to promote circle hook use in almost all hook-and-line fishery sectors that typically interact with istiophorids. However, billfish conservation benefits will only be realized if fishers use unmodified circle hooks, commit to releasing live fish and take other appropriate measures which maximize post-release survival. While there may be fishing modes where circle hook effects are negative, for billfish conservation, we recommend managers grant exceptions to circle hook use only when experimental results support such a practice. [source] Helicobacter pylori Eradication Therapy May Facilitate Gastric Ulcer Healing After Endoscopic Mucosal Resection: A Prospective Randomized StudyHELICOBACTER, Issue 6 2008Jae Hee Cheon Abstract Background and Aim:, It remains unclear whether Helicobacter pylori eradication therapy affects the healing rate of iatrogenic ulcers following endoscopic mucosal resection (EMR) for gastric tumors. The aim of our study was to prospectively evaluate the effect of H. pylori eradication therapy on gastric ulcer healing after EMR. Methods:, After EMR, patients were randomly assigned to either the H. pylori eradication group (Hp group) (lansoprazole 30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, twice a day for 7 days) or the noneradication group (proton pump inhibitor, PPI group) (lansoprazole 30 mg, twice a day for 7 days). Four weeks after EMR, the ulcer stages and size were compared between the two groups. Moreover, ulcer-related symptoms, bleeding rates, adverse effects, and drug compliance were compared. Results:, A total of 64 patients were enrolled. Of these, 17 patients were excluded from the study. The two groups were comparable in terms of baseline clinicopathologic characteristics. Four weeks after EMR, the two groups did not differ with respect to ulcer stage (p = .475) or ulcer-related symptoms (p = .399). However, the ulcer reduction ratio was significantly higher in the Hp group (0.028 ± 0.024 vs. 0.065 ± 0.055, p < .05). No differences were observed between the two groups with regard to drug compliance, adverse drug event rates, or bleeding rates. Conclusions:, Our results suggest that H. pylori eradication therapy might improve the ulcer healing rate after EMR. [source] Bleeding risk with AZD6140, a reversible P2Y12 receptor antagonist, vs. clopidogrel in patients undergoing coronary artery bypass grafting in the DISPERSE2 trialINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 4 2009S. Husted Summary AZD6140, the first reversible oral P2Y12 receptor antagonist, exhibits greater and more consistent inhibition of platelet aggregation than the irreversible thienopyridine clopidogrel. As a result of its reversible effect, AZD6140 may pose less risk for bleeding when antiplatelet treatment cannot be stopped at least 5 days before coronary artery bypass graft (CABG) surgery or other invasive procedures. The Dose conflrmation Study assessing anti-Platelet Effects of AZD6140 vs. clopidogRel in NSTEMI (DISPERSE2) trial showed overall comparable bleeding rates with antiplatelet treatment with AZD6140 90 mg twice daily or 180 mg twice daily vs. clopidogrel 75 mg once daily in 984 patients with non-ST-elevation acute coronary syndromes. A post hoc exploratory analysis of bleeding outcomes in the subset of 84 patients undergoing CABG in DISPERSE2 suggests reduced risk for total bleeding (41% and 58% vs. 62%), all major bleeding (38% and 50% vs. 62%), and life-threatening bleeding (22% and 38% vs. 54%) with AZD6140 90 mg (n = 32) and 180 mg (n = 26) vs. clopidogrel (n = 26) respectively. Trends suggested that major bleeding rates were reduced with AZD6140 (combined groups) vs. clopidogrel when treatment was stopped , 5 days prior to surgery (39% vs. 63%, p = 0.15) but not when treatment was stopped > 5 days before surgery (50% vs. 60%). This observation is consistent with the reversible binding of AZD6140 to the P2Y12 receptor. Further prospective studies are planned to assess the relationship between this potential clinical benefit of AZD6140 and the reversibility of its antiplatelet effects. [source] Effects of tibolone and continuous combined hormone replacement therapy on bleeding rates, quality of life and tolerability in postmenopausal womenBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 8 2002J. Huber Objective To compare the effects of tibolone and conjugated equine oestrogens continuously combined with medroxyprogesterone acetate on bleeding rates, quality of life (QoL) and tolerability. Design A double-blind, randomised comparative trial. Setting Thirty-seven centres in six European countries. Population Five hundred and one postmenopausal women, under 65 years of age with an intact uterus. Interventions For 12 months, women received daily treatment with tibolone 2.5 mg (n= 250), or conjugated equine oestrogens 0.625 mg continuously combined with medroxyprogesterone acetate 5 mg (CEE,MPA, n= 251). Main outcome measures The primary outcome was vaginal bleeding rate during cycles 4,6. The secondary outcomes were vaginal bleeding rate during cycles 1,3, 7,9 and 10,13, cumulative bleeding rate, QoL, wellbeing, climacteric symptoms, urogenital complaints and tolerability. Results Treatment with tibolone led to a significantly lower bleeding rate during cycles 4,6 compared with CEE,MPA (15.0%vs 26.9%; P= 0.004); there was a similar difference during cycles 1,3. Both treatments improved QoL, wellbeing, climacteric symptoms and urogenital complaints. By intent-to-treat analysis, tibolone significantly improved sexual drive, interest and/or performance, compared with CEE,MPA at 12 months (P= 0.017). Although both treatments were well tolerated, there was a significantly lower incidence of breast tenderness with tibolone than CEE,MPA (2.4%vs 17.1%; P < 0.001). Conclusion The vaginal bleeding rate during cycles 4,6 was significantly lower in women using tibolone. Both treatments improved QoL, wellbeing, climacteric symptoms and urogenital symptoms. Breast tenderness was significantly less frequent with tibolone. [source] Teenage and adult tonsillectomy: dose,response relationship between diathermy energy used and morbidityCLINICAL OTOLARYNGOLOGY, Issue 5 2007A.A.J. Cardozo Objective:, To determine whether an increase in the use of bipolar diathermy energy to perform a tonsillectomy is associated with an increase in postoperative pain and haemorrhage. Study design:, Prospective study. Setting:, District General Hospital. Methods:, In all, 101 patients above the age of 13 years who underwent a tonsillectomy that involved the use of bipolar diathermy during the study period were included. The cumulative amount of diathermy energy used to perform each tonsillectomy was calculated with the help of a digital stop clock timing device connected to the diathermy foot-pedal. Main outcome measures:, Postoperative pain scores and the incidence of secondary haemorrhage were recorded for each patient at four points in time following surgery, up to the tenth postoperative day. The haemorrhage rates were categorised into three groups (no bleeding, minor bleeding and major bleeding) according to severity. Associations between the diathermy energy used to perform each tonsillectomy and the corresponding postoperative pain scores and secondary bleeding rates were investigated. Results:, There was a statistically significant positive relationship between the total amount of bipolar diathermy energy used per tonsillectomy and the pain scores at all the four recorded points in time (rs = 0.44,0.72, P < 0.001). When the median energy consumption in the three groups (no bleeding, minor bleeding and major bleeding) were compared using the Kruskal,Wallis test, we found that there was limited evidence of a difference between the groups, but this was not statistically significant at the 5% level [H (2) = 5.374, P = 0.065, 99% CI 0.058,0.071]. Conclusions:, Increased use of bipolar diathermy during the performance of a tonsillectomy is associated with a statistically significant increased amount of postoperative pain. The dose,response relationship between diathermy energy and postoperative bleeding is less clear. This suggests that there could be other important factors such as surgical instrument characteristics and degree of tonsillar adherence that have an additional influence and are therefore possible areas for future research. [source] | ||||||||||