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1.
Optimal Hemostatic Band Duration After Transradial Angiography or Intervention: Insights From a Mixed Treatment Comparison Meta-Analysis of Randomized Trials
Maqsood, M. H., Pancholy, S., Tuozzo, K. A., Moskowitz, N., Rao, S. V., Bangalore, S.
Circulation. Cardiovascular Interventions. 2023;16(2):e012781
Abstract
BACKGROUND The optimal duration of hemostatic compression post transradial access is controversial. Longer duration increases the risk of radial artery occlusion (RAO) while shorter duration increases the risk of access site bleeding or hematoma. As such, a target of 2 hours is typically used. Whether a shorter or longer duration is better is not known. METHODS A PubMed, EMBASE, and clinicaltrials.gov databases were searched for randomized clinical trials of different duration (<90 minutes, 90 minutes, 2 hours, and 2-4 hours) of hemostasis banding. The efficacy outcome was RAO, primary safety outcome was access site hematoma, and secondary safety outcome was access site rebleeding. Primary analysis compared the effect of various duration in reference to the 2 hours duration using a mixed treatment comparison meta-analysis. RESULTS Of the 10 randomized clinical trials included with 4911 patients, when compared to the 2-hour reference duration, there was a significantly higher risk of access site hematoma with 90 minutes (odds ratio, 2.39 [95% CI, 1.40-4.06]) and <90 minutes (odds ratio, 3.61 [95% CI, 1.79-7.29]) but not with the 2 to 4 hours duration. When compared with the 2-hour reference, there was no significant difference in access site rebleeding or RAO with shorter or longer duration but the point estimates favored longer duration for access site rebleeding and shorter duration for RAO. Duration of <90 minutes and 90 minutes ranked 1 and duration of 2 hours ranked 2 as the most efficacious duration whereas duration of 2 hours ranked 1 and 2 to 4 hours ranked 2 as the safest duration. CONCLUSIONS In patients undergoing transradial access for coronary angiography or intervention, a hemostasis duration of 2 hours offers the best balance for efficacy (prevention of RAO) and safety (prevention of access site hematoma/rebleeding).
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2.
Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial
Martel, G., Lenet, T., Wherrett, C., Carrier, F. M., Monette, L., Workneh, A., Brousseau, K., Ruel, M., Chassé, M., Collin, Y., et al
Trials. 2023;24(1):38
Abstract
INTRODUCTION Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection. METHODS This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment. DISCUSSION The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs. TRIAL REGISTRATION ClinicalTrials.gov NCT03651154 . Registered on August 29 2018.
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3.
Surgical bleeding in patients undergoing posterior lumbar inter-body fusion surgery: a randomized clinical trial evaluating the effect of two mechanical ventilation mode types
Hajijafari, M., Ziloochi, M. H., Salimian, M., Fakharian, E.
European Journal of Medical Research. 2023;28(1):114
Abstract
BACKGROUND The purpose of the study was to compare the effect of using volume-controlled ventilation (VCV) versus pressure-controlled ventilation (PCV) on blood loss in patients undergoing posterior lumbar inter-body fusion (PLIF) surgery. METHODS In a randomized, single-blinded, parallel design, 78 patients, candidates for PLIF surgery, were randomly allocated into two groups of 39 to be mechanically ventilated using VCV or PCV mode. All the patients were operated in prone position by one surgeon. Amount of intraoperative surgical bleeding, transfusion requirement, surgeon satisfaction, hemodynamic parameters, heart rate, and blood pressure were measured as outcomes. RESULTS PCV group showed slightly better outcomes than VCV group in terms of mean blood loss (431 cc vs. 465 cc), transfusion requirement (0.40 vs. 0.43 unit), and surgeon satisfaction (82.1% vs. 74.4%); however, the differences were not statistically significant. Diastolic blood pressure 90 and 105 min after induction were significantly lower in PCV group (P = 0.043-0.019, respectively); however, blood pressure at other times, hemoglobin levels, and mean heart rate were similar in two groups. CONCLUSIONS In patients undergoing posterior lumbar inter-body fusion surgery, mode of ventilation cannot make significant difference in terms of blood loss; however, some minor benefits in outcomes may lead to the selection of PCV rather than VCV. More studies with larger sample size, and investigating more factors may be needed.
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4.
Ultrafiltration in cardiac surgery: Results of a systematic review and meta-analysis
Hensley, N. B., Colao, J. A., Zorrilla-Vaca, A., Nanavati, J., Lawton, J. S., Raphael, J., Mazzeffi, M. A., Wierschke, C., Kostibas, M. P., Cho, B. C., et al
Perfusion. 2023;:2676591231157970
Abstract
Background: Ultrafiltration is used with cardiopulmonary bypass to reduce the effects of hemodilution and restore electrolyte balance. We performed a systematic review and meta-analysis to analyze the effect of conventional and modified ultrafiltration on intraoperative blood transfusion.Methods: Utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement, we systematically searched MEDLINE, EMBASE, Web of Science, and Cochrane Library to perform a meta-analysis of studies of randomized controlled trials (RCTs) and observational studies evaluating conventional ultrafiltration (CUF) and modified ultrafiltration (MUF) on the primary outcome of intraoperative red cell transfusions.Results: A total of 7 RCTs (n = 928) were included, comparing modified ultrafiltration (n = 473 patients) to controls (n = 455 patients) and 2 observational studies (n = 47,007), comparing conventional ultrafiltration (n = 21,748) to controls (n = 25,427). Overall, MUF was associated with transfusion of fewer intraoperative red cell units per patient (n = 7); MD -0.73 units; 95% CI -1.12 to -0.35 p = 0.04; p for heterogeneity = 0.0001, I(2) = 55%) compared to controls. CUF was no difference in intraoperative red cell transfusions compared to controls (n = 2); OR 3.09; 95% CI 0.26-36.59; p = 0.37; p for heterogeneity = 0.94, I(2) = 0%. Review of the included observational studies revealed an association between larger volumes (>2.2 L in a 70 kg patient) of CUF and risk of acute kidney injury (AKI).Conclusion: The results of this systematic review and meta-analysis suggest that MUF is associated with fewer intraoperative red cell transfusions. Based on limited studies, CUF does not appear to be associated with a difference in intraoperative red cell transfusion.
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5.
Hemostatic spray (TC-325) vs. standard endoscopic therapy for non-variceal gastrointestinal bleeding: A meta-analysis of randomized controlled trials
Deliwala SS, Chandan S, Mohan BP, Khan S, Reddy N, Ramai D, Bapaye JA, Dahiya DS, Kassab LL, Facciorusso A, et al
Endoscopy international open. 2023;11(3):E288-e295
Abstract
Background and study aims Hemospray (TC-325) is a mineral powder with adsorptive properties designed for use in various gastrointestinal bleeding (GIB) scenarios. We conducted a systematic review & meta-analysis of randomized controlled trials (RCTs) comparing TC-325 to standard endoscopic therapy (SET) for non-variceal GIB (NVGIB). Methods Multiple databases were searched through October 2022. Meta-analysis was performed using a random-effects model to determine pooled relative risk (RR) and proportions with 95 % confidence intervals (CI) for primary hemostasis, hemostasis failure, 30-day rebleeding, length of stay (LOS), and need for rescue interventions. Heterogeneity was assessed using I (2) %. Results Five RCTs with 362 patients (TC-325 178, SET 184) - 123 females and 239 males with a mean age 65 ± 16 years). The most common etiologies were peptic ulcer disease (48 %), malignancies (35 %), and others (17 %). Bleeding was characterized as Forrest IA (7 %), IB (73 %), IIA (3 %), and IIB (1 %). SET included epinephrine injection, electrocautery, hemoclips, or a combination. No statistical difference in primary hemostasis between TC-325 compared to SET, RR 1.09 (CI 0.95-1.25; I (2) 43), P = 0.2, including patients with oozing/spurting hemorrhage, RR 1.13 (CI 0.98-1.3; I (2) 35), P = 0.08. Failure to achieve hemostasis was higher in SET compared to TC-325, RR 0.30 (CI 0.12-0.77, I (2) 0), P = 0.01, including patients with oozing/spurting hemorrhage, RR 0.24 (CI 0.09 - 0.63, I (2) 0), P = 0.004. We found no difference between the two interventions in terms of rebleeding, RR 1.13 (CI 0.62-2.07, I (2) 26), P = 0.8 and LOS, standardized mean difference (SMD) 0.27 (CI, -0.20-0.74; I (2) 62), P = 0.3. Finally, pooled rate of rescue interventions (angiography) was statistically higher in SET compared to TC-325, RR 0.68 (CI 0.5-0.94; I (2) 0), P = 0.02. Conclusions Our analysis shows that for acute NV GIB, including oozing/spurting hemorrhage, TC-325 does not result in higher rates of primary hemostasis compared to SET. However, lower rates of failures were seen with TC-325 than SET. In addition, there was no difference in the two modalities when comparing rates of rebleeding and LOS.
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6.
The Impact of Surgical Indication on Posttonsillectomy Hemorrhage: A Systematic Review and Meta-Analysis
Gutierrez, J. A., Shannon, C. M., Nguyen, S. A., Labadie, R. F., White, D. R.
Otolaryngology--Head and Neck Surgery : Official Journal of American Academy of Otolaryngology-Head and Neck Surgery. 2023
Abstract
OBJECTIVE To investigate the impact of the surgical indication on posttonsillectomy bleed rates. DATA SOURCES PubMed, Scopus, CINAHL. REVIEW METHODS A systematic review was performed searching for articles published from the date of inception to July 6, 2022. English language articles describing posttonsillectomy hemorrhage rates in pediatric patients (age ≤ 18) stratified by indication were selected for inclusion. A meta-analysis of proportions with comparison (Δ) of weighted proportions was conducted. All studies were assessed for risk of bias. RESULTS A total of 72 articles with 173,970 patients were selected for inclusion. The most common indications were chronic/recurrent tonsillitis (CT/RT), obstructive sleep apnea/sleep-disordered breathing (OSA/SDB), and adenotonsillar hypertrophy (ATH). Posttonsillectomy hemorrhage rates for CT/RT, OSA/SDB, and ATH were 3.57%, 3.69%, and 2.72%, respectively. Patients operated on for a combination of CT/RT and OSA/SDB had a bleed rate of 5.99% which was significantly higher than those operated on for CT/RT alone (Δ2.42%, p = .0006), OSA/SDB alone (Δ2.30%, p = .0016), and ATH alone (Δ3.27%, p < .0001). Additionally, those operated on for a combination of ATH and CT/RT had a hemorrhage rate of 6.93%, significantly higher than those operated on for CT/RT alone (Δ3.36%, p = .0003), OSA/SDB alone (Δ3.01%, p = .0014), and ATH alone (Δ3.98%, p < .0001). CONCLUSION Patients operated on for multiple indications had significantly higher rates of posttonsillectomy hemorrhage than those operated on for a single surgical indication. Better documentation of patients with multiple indications would help further characterize the magnitude of the compounding effect described here.
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7.
The Effect of Tourniquet Duration on Pain, Bleeding, and Functional Outcomes in Total Knee Arthroplasty
Çi Nka H, Yurtbay A, Erdoğan F, Büyükceran İ, Coşkun HS, Tomak Y
Cureus. 2023;15(2):e34606
Abstract
Objective The aim of this study was to evaluate the effects of tourniquet use on perioperative blood loss, pain, and functional and clinical outcomes. Patients and methods This is a prospective study that included 80 knees who underwent total knee arthroplasty. The patients were separated into two groups: those with a tourniquet used throughout the entire surgical procedure and those where the tourniquet was only used during the cementation procedure. In the postoperative period, the pain levels of the patients were evaluated using a visual analog scale (VAS), and the functional results were evaluated with knee range of motion measurement, the Western Ontario and Mcmaster Universities Osteoarthritis (WOMAC) index, the Knee Injury and Osteoarthritis Outcome Score (KOOS), the Kujala Patellofemoral Scoring System, and the Oxford Knee Scoring system. The patients were examined in the early postoperative period and again in the 12th week, including possible complications that may develop postoperatively. Results In the early postoperative period, a greater hemoglobin decrease and calculated blood loss values, better functional clinical results, and better knee range of motion were determined in the group with a tourniquet applied only during the cementation, and the swelling in the knee was less (p<0.05). However, the difference between the two groups had disappeared by the postoperative 12th week. There was no significant difference in respect of complications. Conclusion Limiting the duration of tourniquet use during total knee arthroplasty has the significant advantage of providing better functional results with less pain in the early postoperative period.
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8.
Impact of time and distance on outcomes following tourniquet use in civilian and military settings: A scoping review
Joarder M, Noureddine El Moussaoui H, Das A, Williamson F, Wullschleger M
Injury. 2023
Abstract
BACKGROUND The last two decades have seen the reintroduction of tourniquets into guidelines for the management of acute limb trauma requiring hemorrhage control. Evidence supporting tourniquet application has demonstrated low complication rates in modern military settings involving rapid evacuation timeframes. It is unclear how these findings translate to patients who have prolonged transport times from injury in rural settings. This scoping review investigates the relationship between time and distance on metabolic complications, limb salvage and mortality following tourniquet use in civilian and military settings. METHODS A systematic search strategy was conducted using PubMed, Embase, and SafetyLit databases. Study characteristics, setting, mechanism of injury, prehospital time, tourniquet time, distance, limb salvage, metabolic response, mortality, and tourniquet removal details were extracted from eligible studies. Descriptive statistics were recorded, and studies were grouped by ischemia time (< 2 h, 2-4 h, or > 4 h). RESULTS The search identified 3103 studies, from which 86 studies were included in this scoping review. Of the 86 studies, 55 studies were primarily in civilian environments and 32 were based in military settings. One study included both settings. Blast injury was the most common mechanism of injury sustained by patients in military settings (72.8% [5968/8200]) followed by penetrating injury (23.5% [1926/8200]). In contrast, in civilian settings penetrating injury was the most common mechanism (47.7% [1633/3426]) followed by blunt injury (36.4% [1246/3426]). Tourniquet time was reported in 66/86 studies. Tourniquet time over four hours was associated with reduced limb salvage rates (57.1%) and higher mortality rates (7.1%) compared with a tourniquet time of less than two hours. The overall limb salvage and mortality rates were 69.6% and 6.7% respectively. Metabolic outcomes were reported in 28/86 studies with smaller sample sizes and inconsistencies in which parameters were reported. CONCLUSION This scoping review presents literature describing comparatively safe tourniquet application when used for less than two hours duration. However, there is limited research describing prolonged tourniquet application or when used for protracted distances, such that the impact of tourniquet release time on metabolic outcomes and complications remains unclear. Prospective studies utilizing the development of an international database to provide this dataset is required.
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9.
Effect of Endometrial Ablation by Thermal Balloon vs. Hysteroscopy Ablation on Amenorrhea Rates in Patients with Abnormal Uterine Bleeding: A Randomized Clinical Trial
Mohamadianamir M, Mohazzab A, Rokhgire S, Mansouri Z, Yazdizadeh M, Ghezelbash S, Aklamli M, Azizi S
International journal of fertility & sterility. 2023;17(2):133-139
Abstract
BACKGROUND Abnormal uterine bleeding (AUB) that is any irregularity in menstrual cycles causes women to refer to clinics. This study aimed to compare the efficacy, safety, and complications of endometrial ablation by the thermal balloon (Cavaterm) method with the hysteroscopy loop resection method in the treatment of AUB. MATERIALS AND METHODS The present study is an open-label, randomized clinical trial that was performed in the two hospitals, Shahid Akbarabadi and Hazrat Rasoul Akram, of Tehran, Iran, from December 2019 to October 2020. Patients were randomly allocated to the two groups of interventions by a simple randomization method. The proportion of amenorrhea (as primary outcome) and consequent hysterectomy and patient satisfaction (as secondary outcomes) was assessed using the Chi-square test and independent t test. RESULTS There was no significant difference between the two groups in the baseline characteristics. The percentage of intervention failure was statistically higher in the hysteroscopy group (24%) in comparison with the Cavaterm group [8.2%, P=0.03, relative risk (RR)=1.63, 95% confidence interval (CI): 1.13-2.36]. Mean ± standard deviation of satisfaction based on the Likert score in the Cavaterm group and hysteroscopy group were 4.3 ± 1.21 and 3.7 ± 1.56, respectively, that showed a significant difference (P=0.04). Assessing the procedural complications, the rate of spotting, bloody discharge, and malodor discharge was significantly higher in the Cavaterm group. In contrast, postoperative dysmenorrhea is more common in the hysteroscopy group. CONCLUSION Cavaterm ablation is accompanied by a higher success rate of amenorrhea and patients' satisfaction than hysteroscopy ablation (registration number: IRCT20220210053986N1).
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10.
Complications of revision surgery in case of bleeding after thyroid surgery: A systematic review
Galluzzi F, Garavello W
European annals of otorhinolaryngology, head and neck diseases. 2023
Abstract
OBJECTIVES The aim of this review is to evaluate complications in patients undergoing surgical control of bleeding after thyroid surgery. Secondly, we have analyzed the rate of the main complications. METHODS The databases PubMed and EMBASE were searched for articles regarding complications after revision thyroid surgery for bleeding. A Systematic review methodology based on Preferred Reporting Items for Systematic Reviews and Meta-analysis was performed. RESULTS Nine studies met the inclusion criteria, six are retrospectives and three retrospectives controlled. The overall rate of bleeding after thyroid surgery was 1.38%. In these patients, the most common complication after revision surgery for bleeding is hypoparathyroidism 24.9% (95% CI: 20.7-29.5) followed by recurrent laryngeal nerve injury 8.1% (95% CI: 6.4-10.1) and wound infection 4.5% (95% CI: 2.5-7.6). Tracheostomy and other lethal complications are rarely described. CONCLUSION Although rare, complications after surgical control of bleeding in patients undergoing thyroid surgery can be serious. Therefore, in order to optimize the surgical outcomes, standardized protocol providing early detection and precise hemostasis procedure, is needed. Specific patient-informed consent for this condition should be created.
