Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial
PloS one. 2022;17(6):e0270640
BACKGROUND Patients with colorectal cancer have a high risk of iron deficiency anaemia (IDA) due to chronic tumour induced blood loss, a reduced dietary iron intake from poor nutrition or gastrointestinal malabsorption. This pilot, double blinded, randomised controlled trial (RCT) examined the effect and feasibility of using preoperative iron isomaltoside for treating iron deficiency anaemia. METHODS Forty eligible adults with IDA were randomised to receive either intravenous iron isomaltoside (20 mg.kg-1 up to 1000 mg over 30 minutes) or usual preoperative care (control) three weeks before scheduled colorectal surgery. The primary outcomes were perioperative changes in haemoglobin and ferritin concentrations. RESULTS The recruitment rate was 78% of all eligible referred patients (1.9 patients/month). The haemoglobin and ferritin concentrations were higher in the iron isomaltoside group than the control group over the perioperative period (group*time interaction P = 0.042 and P < 0.001 respectively). Mean haemoglobin change from baseline to before surgery was higher in the iron isomaltoside group (7.8, 95% CI: 3.2 to 12.3 g.l-1) than the control group (1.7, 95% CI: -1.9 to 5.3 g.l-1) [mean difference 6.1, 95% CI: 0.3 to 11.8 g.l-1; P = 0.040]. The ferritin change from baseline to before surgery between groups was large in favour of the iron isomaltoside group (mean difference 296.9, 95% CI: 200.6 to 393.2 μg.l-1; P < 0.001]. There were no differences between groups in packed red blood cell transfusions needed, surgical complications, quality of recovery and days (alive and) at home within 30 days after surgery. CONCLUSION Iron isomaltoside therapy was safe and had a minimal effect on perioperative changes in haemoglobin concentration. Given the slow recruitment and new evidence emerging during the conduct of this study, conducting a multi-centre RCT based on the current pilot trial protocol is unlikely to be feasible. TRIAL REGISTRATION ClinicalTrials.gov NCT03565354.
Intraoperative balloon occlusion of the aorta for blood management in sacral and pelvic tumor resection: A systematic review and meta-analysis
Surgical oncology. 2020;35:156-161
BACKGROUND Neoplasms of the sacrum and pelvis are challenging to manage due to their complex vascularity and size and are at high risk of bleeding during resection. Intra-aortic balloon occlusion (IABO) has been used in trauma to control massive blood loss, but its efficacy and safety in oncologic sacral and pelvic surgery are unknown. The primary objective of this systematic review and meta-analysis was to assess the effectiveness of IABO in providing hemorrhage control during resection of sacral and pelvic tumors. METHODS This PROSPERO pre-registered study meta-analyzed all studies reporting on the use of IABO in the setting of pelvic and sacral tumour resection, in accordance with the PRISMA guidelines. The primary outcome of the meta-analysis was intraoperative blood loss, with secondary outcomes consisting of transfusion volume, post-operative blood loss, operative time, complication rate, and mortality. RESULTS Across studies, IABO was associated with a large, significant reduction in intraoperative blood loss (SMD -0.81, 95% CI -1.01 to -0.60, P < 0.0001) and transfused red blood cell volume (SMD 0.92, 95% CI -1.30 to -0.53, P < 0.0001). Two studies reported that complication rates were comparable between patients receiving IABO and patient receiving conventional surgery (Odds ratio = 1.29, 95% CI: 0.59 to 2.83, P = 0.52). All studies descriptively reported improved visualization of the operative field with IABO. CONCLUSIONS Our findings demonstrated that IABO is an effective technique to decrease blood loss and transfusion requirements during sacral and pelvic tumor surgery. Future clinical trials should be conducted to establish the safety of this method and explore potential contraindications.
The Spot sign and Tranexamic acid On Preventing ICH growth - AUStralasia Trial (STOP-AUST): Protocol of a phase II randomized, placebo-controlled, double-blind, multicenter trial
International Journal of Stroke. 2014;9((4):):519-24.
RATIONALE No evidence-based acute therapies exist for intracerebral hemorrhage. Intracerebral hemorrhage growth is an important determinant of patient outcome. Tranexamic acid is known to reduce hemorrhage in other conditions. AIM: The study aims to test the hypothesis that intracerebral hemorrhage patients selected with computed tomography angiography contrast extravasation 'spot sign' will have lower rates of hematoma growth when treated with intravenous tranexamic acid within 45-hours of stroke onset compared with placebo. DESIGN The Spot sign and Tranexamic acid On Preventing ICH growth - AUStralasia Trial is a multicenter, prospective, 1:1 randomized, double-blind, placebo-controlled, investigator-initiated, academic Phase II trial. Intracerebral hemorrhage patients fulfilling clinical criteria (e.g. Glasgow Coma Scale >7, intracerebral hemorrhage volume <70ml, no identified secondary cause of intracerebral hemorrhage, no thrombotic events within the previous 12 months, no planned surgery) and demonstrating contrast extravasation on computed tomography angiography will receive either intravenous tranexamic acid 1g 10-min bolus followed by 1g eight-hour infusion or placebo. A second computed tomography will be performed at 24 + 3 hours to evaluate intracerebral hemorrhage growth and patients followed up for three-months. STUDY OUTCOMES The primary outcome measure is presence of intracerebral hemorrhage growth by 24 + 3 hours, defined as either >33% or >6ml increase from baseline, and will be adjusted for baseline intracerebral hemorrhage volume. Secondary outcome measures include growth as a continuous measure, thromboembolic events, and the three-month modified Rankin Scale score. DISCUSSION This is the first trial to evaluate the efficacy of tranexamic acid in intracerebral hemorrhage patients selected based on an imaging biomarker of high likelihood of hematoma growth. The trial is registered as NCT01702636. 2013 The Authors. International Journal of Stroke 2013 World Stroke Organization.
Aprotinin shows both hemostatic and antithrombotic effects during off-pump coronary artery bypass grafting
The Annals of Thoracic Surgery. 2006;81((1):):104-10; discussion 110-1.
BACKGROUND Hemostatic drugs are widely thought to be unnecessary and potentially detrimental in off-pump coronary artery bypass graft surgery (OPCABG), despite well-established use in on-pump surgery. In a randomized, prospective OPCABG trial, we assessed efficacy and safety of aprotinin through a comprehensive assessment of graft patency and hematologic function. METHODS Sixty patients were randomly assigned to full-dose aprotinin or placebo. Heparin was titrated to a kaolin-based activated clotting time of greater than 300 seconds. Exclusionary criteria included creatinine greater than 2 mg/dL, conversion to on-pump CABG, and preoperative GPIIb/IIIa inhibition. Hematologic assessments were obtained preoperatively, at the end of surgery, and on days 1 and 3: mean platelet volume, thrombin generation (prothrombin fragment 1. 2 assay), and aspirin resistance using a modified thrombelastography, whole blood aggregometry, 11-dehydro-thromboxane B2 levels, and flow cytometry. Thrombotic events were defined as postoperative myocardial infarction by electrocardiography or elevated troponin I, clinical stroke by examination and head computed tomography, and bypass graft failure by multichannel computed tomography angiography on day 5. RESULTS Aprotinin was associated with a significant reduction in intraoperative and postoperative blood loss compared with placebo but had no effect on transfusion rates. Patients treated with aprotinin had significantly fewer thrombotic events (3% versus 23%, p < 0. 05, Fisher's exact test) and less postoperative aspirin resistance (20% versus 46%, respectively, p < 0. 05, Fisher's exact test). Postoperative prothrombin fragment 1. 2 level was reduced by aprotinin use. CONCLUSIONS Aprotinin reduced perioperative bleeding after OPCABG. Preserved aspirin sensitivity in the aprotinin group may explain the observed reduction in thrombotic events and might be related to the suppression of perioperative and transmyocardial thrombin formation.