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Full Correction of Posttransplant Anemia Is Associated With Stabilized Cardiac Dimensions Among Kidney Transplant Recipients: A Prospective Randomized Controlled Trial
Al-Otaibi, T., Nagib, A. M., Halim, M. A., Abo-Atya, H., Mahmoud, T., Nair, P., Adel, H., Mosaad, A., Fathy, A., Abdul-Hameed, M., et al
Experimental and clinical transplantation : official journal of the Middle East Society for Organ Transplantation. 2024;22(Suppl 1):323-331
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Editor's Choice
Abstract
OBJECTIVES Posttransplant anemia might be associated with cardiovascular morbidity and increased mortality. To our knowledge, the debate on anemia correction has neither been revisited nor decided definitively. We aimed to assess the effects of full correction of posttransplant anemia on the cardiovascular system and quality of life among renal transplant recipients with stable graft function who were using erythropoietin-stimulating agents. MATERIALS AND METHODS We enrolled 247 kidney recipients with stable graft function to be assessed for anemia. Eligible patients were randomized to achieve targeted hemoglobin of 11 to 12 g/dL (group 1, n = 183) or of 13 to 15 g/dL (group 2, n = 64) with the use of erythropoietin-stimulating agents. Patients underwent monthly clinical and laboratory evaluations of kidney graft function. Quality of life and echocardiography were assessed at study start and at 12 months. RESULTS The 2 groups were comparable regarding pretransplant characteristics. In group 2, we observed comparable posttransplant complications (P > .05) but better graft function at 6 months and better cardiac indexes at 1 year of the study (P < .05). At 12 months, quality of life had improved after full correction of posttransplant anemia in the renal transplant recipients who received erythropoietinstimulating agents. CONCLUSIONS Full correction of posttransplant anemia in renal transplant recipients was associated with improved quality of life and cardiac indexes without an effect on cardiovascular comorbidity.
PICO Summary
Population
Adult kidney transplant recipients with stable graft function (n= 247).
Intervention
Targeted haemoglobin of 11 to 12 g/dL with the use of erythropoietin-stimulating agents (ESA) (group 1, n= 183)
Comparison
Targeted haemoglobin of 13 to 15 g/dL with ESA (group 2, n= 64)
Outcome
Patients underwent monthly clinical and laboratory evaluations of kidney graft function. Quality of life and echocardiography were assessed at study start and at 12 months. In group 2, there were comparable post-transplant complications, but better graft function at 6 months and better cardiac indexes at 1 year of the study. At 12 months, quality of life had improved after full correction of post-transplant anaemia in the renal transplant recipients who received erythropoietin-stimulating agents.
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Desmopressin Acetate in Percutaneous Ultrasound-Guided Native Kidney Biopsy in Patients with Reduced Kidney Function: A Double-Blind Randomized Controlled Trial
Sattari SA, Shahoori A, Shahbazian H, Sabetnia L, Aref A, Sattari AR, Ghorbani A
Iranian journal of kidney diseases. 2022;16(4):238-245
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Abstract
INTRODUCTION Bleeding events are the most common complications after kidney biopsy. This study aims to evaluate the effect of desmopressin administration on bleeding complication, in native kidney biopsy candidates with reduced kidney function. METHODS This double-blind randomized clinical trial enrolled 18 to 80 years old patients with 15 < eGFR < 90 mL/min/ 1.73m² from July 2017 to August 2020. Patients were randomly assigned to receive either 3 µg/kg of intranasal desmopressin acetate or 1 mL/kg of intranasal sodium chloride 0.65%, one hour before ultrasound-guided, percutaneous native kidney biopsy. The primary outcome was the post-biopsy bleeding complications, and secondary outcomes were the volume of perirenal hematoma, and changes of post-biopsy hemoglobin and hematocrit level, plasma sodium and blood pressure (Clinical Trial Registration ID: IRCT20090701002112N3). RESULTS A total of 120 patients (58 men and 62 women), 60 patients in each group, were analyzed. The mean age and eGFR of the patients were 45.29 ± 15.95 years and 51.77 ± 18.02 ml/min/ 1.73m², respectively. Desmopressin administration significantly decreased post-biopsy perirenal hematoma compared to placebo (7/60 [11.6%]) vs. 33/60 [40%]; P < .05), and the hematoma volume was significantly smaller in the desmopressin group, in case of hematoma formation (2.31 ± 1.17 vs. 7.72 ± 5.45 mm³, P < .05). CONCLUSION Desmopressin administration before kidney biopsy is a safe and effective strategy to prevent bleeding complications. Considering absolute risk reduction of about 28%, the number needed to treat is about 4 procedures. We recommend considering desmopressin administration before percutaneous native kidney biopsy. DOI: 10.52547/ijkd.6966.
PICO Summary
Population
Adult patients with kidney disease, who were candidates for percutaneous native kidney biopsy (n= 120).
Intervention
Intranasal desmopressin acetate (n= 60).
Comparison
Placebo: intranasal sodium chloride (n= 60).
Outcome
Desmopressin administration significantly decreased post-biopsy perirenal haematoma compared to placebo (7/60 [11.6%]) vs. 33/60 [40%]), and the haematoma volume was significantly smaller in the desmopressin group, in case of haematoma formation (2.31 ± 1.17 vs. 7.72 ± 5.45 mm³).
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Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2)
Meier B, Wannhoff A, Denzer U, Stathopoulos P, Schumacher B, Albers D, Hoffmeister A, Feisthammel J, Walter B, Meining A, et al
Gut. 2022
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Editor's Choice
Abstract
OBJECTIVE Acute non-variceal upper gastrointestinal bleeding (NVUGIB) is managed by standard endoscopic combination therapy, but a few cases remain difficult and carry a high risk of persistent or recurrent bleeding. The aim of our study was to compare first-line over-the-scope-clips (OTSC) therapy with standard endoscopic treatment in these selected patients. DESIGN We conducted a prospective, randomised, controlled, multicentre study (NCT03331224). Patients with endoscopic evidence of acute NVUGIB and high risk of rebleeding (defined as complete Rockall Score ≥7) were included. Primary endpoint was clinical success defined as successful endoscopic haemostasis without evidence of recurrent bleeding. RESULTS 246 patients were screened and 100 patients were finally randomised (mean of 5 cases/centre and year; 70% male, 30% female, mean age 78 years; OTSC group n=48, standard group n=52). All but one case in the standard group were treated with conventional clips. Clinical success was 91.7% (n=44) in the OTSC group compared with 73.1% (n=38) in the ST group (p=0.019), with persistent bleeding occurring in 0 vs 6 in the OTSC versus standard group (p=0.027), all of the latter being successfully managed by rescue therapy with OTSC. Recurrent bleeding was observed in four patients (8.3%) in the OTSC group and in eight patients (15.4%) in the standard group (p=0.362). CONCLUSION OTSC therapy appears to be superior to standard treatment with clips when used by trained physicians for selected cases of primary therapy of NVUGIB with high risk of rebleeding. Further studies are necessary with regards to patient selection to identify subgroups benefiting most from OTSC haemostasis. TRIAL REGISTRATION NUMBER NCT03331224.
PICO Summary
Population
High-risk patients with acute non-variceal upper gastrointestinal bleeding enrolled in the STING-2 trial (n= 100).
Intervention
First-line over-the-scope-clips therapy (OTSC group, n= 48).
Comparison
Standard endoscopic treatment (ST group, n= 52).
Outcome
Clinical success was 91.7% (44 patients) in the OTSC group compared with 73.1% (38 patients) in the ST group. Persistent bleeding occurred in 11.5% (6 patients) in the ST group, vs. zero patients in the OTSC group. Recurrent bleeding was observed in 8.3% (4 patients) in the OTSC group and in 15.4% (8 patients) in the ST group.
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Can trajectory nor-epinephrine infiltration reduce blood loss during percutaneous nephrolithotomy? A double-blinded randomized controlled trial
El-Shaer W, Haggag MS, Elshaer A, Shaboob I, Kandeel W, Elmohamady B, Abdelmotaleb DS, Abdel-Lateef S
International journal of urology : official journal of the Japanese Urological Association. 2022
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Editor's Choice
Abstract
PURPOSE To determine the efficacy and safety of trajectory infiltration with 1:150 000 Norepinephrine (NE) in reducing blood loss during percutaneous nephrolithotomy (PCNL). MATERIALS AND METHODS This is a prospective randomized double-blinded placebo-controlled trial. In all, 140 consecutive patients underwent PCNL for the management of large renal calculi. They were randomly assigned (1:1) to one of either study groups, the NE-PCNL group (70 patients whose PCNL-trajectory was infiltrated by NE) or the Placebo group (saline PCNL) (70 patients whose PCNL tracts were infiltrated by normal saline). Procedure-related blood loss (the primary outcome) was assessed and statistically analyzed. Also, all other procedure-related events and complications were recorded and compared. RESULTS The median blood loss was 378 ml (IQR: 252-504) in the NE-PCNL group versus 592 ml (IQR: 378-756) in the S-PCNL group (p < 0.0001). In addition, Hemoglobin and Hematocrit deficits were lower in NE-PCNL (p < 0.05). Patients who were randomized to the NE-PCNL group had a higher immediate stone-free rate (SFR) (80%) compared with those of the S-PCNL group (70%) (p = 0.034). However, no statistical differences were found in the final SFR. The reported overall complications between the 2 groups were similar (p > 0.05). Indeed, bleeding-related complications were 1 (1.4%) versus 10 (14.3%) for NE-PCNL and S-PCNL, respectively (p = 0.009). CONCLUSIONS Trajectory infiltration of PCNL tracts by NE was found to be effective and safe in mitigation of PCNL-related blood loss. This step is a timeless and cost-effective as NE is readily available in surgical theaters and of very low cost.
PICO Summary
Population
Patients undergoing percutaneous nephrolithotomy (PCNL) (n= 140).
Intervention
PCNL after tract infiltration with norepinephrine (NE) (NE-PCNL group, n= 70).
Comparison
PCNL after tract infiltration with normal saline (S-PCNL group, n= 70).
Outcome
The primary outcome was procedure-related blood loss. The median blood loss was 378 ml (IQR= 252, 504) in the NE-PCNL group versus 592 ml (IQR= 378, 756) in the S-PCNL group. Haemoglobin and haematocrit deficits were lower in NE-PCNL. Patients in the NE-PCNL group had a higher immediate stone-free rate (80%) compared with those of the S-PCNL group (70%). No statistical differences were found in the final stone free rate. The reported overall complications between the two groups were similar. Bleeding-related complications were 1 (1.4%) versus 10 (14.3%) for NE-PCNL and S-PCNL, respectively.
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Propranolol vs. band ligation for primary prophylaxis of variceal hemorrhage in cirrhotic patients with ascites: a randomized controlled trial
Singh V, Kumar P, Verma N, Vijayvergiya R, Singh A, Bhalla A
Hepatology international. 2022
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Editor's Choice
Abstract
BACKGROUND AND AIMS Recent studies have debated the utility of beta-blockers to prevent variceal hemorrhage (V.H.) in cirrhosis patients with ascites. We aimed to evaluate the safety and efficacy of propranolol (PPL) compared to endoscopic variceal ligation (EVL) for V.H. primary prevention in patients with ascites. METHODS Cirrhosis patients with ≥ grade 2 ascites and varices needing primary prophylaxis were randomly assigned to receive either PPL (n = 80) or EVL (n = 80). Patients were followed monthly until 12 months or transplant or death. The primary endpoint was 12-month transplant-free-survival (TFS). Secondary endpoints were the incidence of V.H., acute kidney injury (AKI), and control of ascites. RESULTS Baseline characteristics were similar between the groups. PPL-group had a lower 12-month TFS (76.0% vs. 89.7%; p = 0.02) as compared with EVL-group. Mean arterial pressure ≤ 82 mmHg and MELD-sodium were the independent predictors of mortality. Incidence of VH was comparable between PPL and EVL-groups [6 (7.5%) vs. 2 (2.5%), p = 0.13]. In PPL vs. EVL-group, more patients had worsening of ascites (15% vs. 5%; p = 0.03), developed refractory ascites (13.7% vs.3.7%; p = 0.02), relapse of ascites (37.1% vs. 16.4%, p < 0.01), and AKI (26.2% vs. 12.5%; p = 0.02). Side effects were comparable between the two groups. CONCLUSIONS Primary VH-prophylaxis with PPL is associated with lower survival, poor control of ascites, and increased risk of AKI in cirrhosis patients with ≥ grade 2 ascites. PPL and EVL are equally effective in preventing V.H. Serial monitoring of blood pressures and renal functions is needed in cirrhosis patients with ascites on PPL (NCT02649335).
PICO Summary
Population
Cirrhosis patients with ascites and esophageal varices (n= 160).
Intervention
Propranolol (PPL), (PPL group, n= 80).
Comparison
Endoscopic variceal ligation (EVL), (EVL group, n= 80).
Outcome
Patients receiving PPL had a lower 12-month transplant-free-survival (76.0% vs. 89.7%) compared with patients who had EVL. Mean arterial pressure ≤ 82 mmHg and MELD-sodium were the independent predictors of mortality. Incidence of variceal haemorrhage was comparable between the PPL and EVL groups [6 (7.5%) vs. 2 (2.5%)]. In the PPL vs. EVL group, more patients had worsening of ascites (15% vs. 5%), developed refractory ascites (13.7% vs. 3.7%), relapse of ascites (37.1% vs. 16.4%), and acute kidney injury (26.2% vs. 12.5%). Side effects were comparable between both groups.
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Development and validation of a nomogram to predict intraoperative blood transfusion for gastric cancer surgery
Huang H, Cao M
Transfusion medicine (Oxford, England). 2021
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Editor's Choice
Abstract
OBJECTIVE To construct and validate a nomogram composed of preoperative variables to predict intraoperative blood transfusion for gastric cancer surgery. BACKGROUND Intraoperative transfusion for gastric cancer surgery is a common medical procedure that is associated with increased postoperative complications. METHODS A total of 999 patients who underwent gastrectomy between January 2010 and June 2019 were randomly allocated into the primary and validation cohorts in a 2:1 ratio. In the primary cohort, logistic analyses were performed to identify independent predictors for transfusion. Using the Akaike information criterion, selected variables were incorporated to construct a nomogram. Validations of the nomogram were performed in the primary and validation cohorts. The discrimination ability of the nomogram was assessed by the concordance index (C-index), and calibration was assessed by calibration curves and the Hosmer-Lemeshow goodness-of-fit test. RESULTS The following risk factors for transfusion were identified and used to construct the nomogram: ASA status (III-IV vs I-II: odds ratio [OR] 1.74), comorbidities (yes vs no: OR 1.57), tumour location (diffuse vs lower: OR 4.05), cTNM stage (III vs I: OR 1.95), and a preoperative haemoglobin level less than 80 g/L (vs over 120 g/L: OR 35.30). The C-index was 0.859 and 0.850 in the primary and validation cohorts, respectively, which both indicated good discrimination of the nomogram. Additionally, both calibration curves and Hosmer-Lemeshow tests (p-value 0.184 and 0.887, respectively) demonstrated high agreement between the predictions and actual outcomes. CONCLUSION A nomogram composed of preoperative variables to predict blood transfusion for gastric cancer surgery was effectively developed and validated. This nomogram could be used to improve the utilisation of red blood cells for gastrectomy.
PICO Summary
Population
Patients undergoing gastric cancer surgery (n= 999).
Intervention
Nomogram of preoperative variables to predict intraoperative blood transfusion (primary cohort, n= 666).
Comparison
Nomogram of preoperative variables to predict intraoperative blood transfusion (validation cohort, n= 333).
Outcome
The following risk factors for transfusion were identified and used to construct the nomogram: ASA (American Society of Anaesthesiologists) physical status, comorbidities, tumour location, Clinical Tumour-Lymph Node-Metastasis stage, and a preoperative haemoglobin level less than 80 g/L. The concordance index was 0.859 and 0.850 in the primary and validation cohorts, respectively, which both indicated good discrimination of the nomogram. Additionally, both calibration curves and Hosmer-Lemeshow tests demonstrated high agreement between the predictions and actual outcomes.
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Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial
Lancet. 2020;395(10241):1927-1936
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Editor's Choice
Abstract
BACKGROUND Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. METHODS We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0.9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0.9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and http://clinicaltrials.gov/ ClinicalTrials.gov, NCT01658124. FINDINGS Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49.9%) or matching placebo (6015, 50.1%), of whom 11 952 (99.5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0.99, 95% CI 0.82-1.18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0.7%] of 5952 vs 46 [0.8%] of 5977; 0.92; 0.60 to 1.39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0.8%] of 5952 vs 26 [0.4%] of 5977; RR 1.85; 95% CI 1.15 to 2.98). INTERPRETATION We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial. FUNDING UK National Institute for Health Research Health Technology Assessment Programme.
PICO Summary
Population
Patients with gastrointestinal bleeding enrolled in the HALT-IT trial (n= 12009).
Intervention
Loading dose of tranexamic acid followed by a maintenance dose of tranexamic acid (n= 5994).
Comparison
Placebo: sodium chloride (n= 6015).
Outcome
Death due to bleeding within 5 days of randomisation occurred in (4%) of patients in the tranexamic acid group and in (4%) of patients in the placebo group. Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (0.7%) vs. (0.8%). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (0.8%) vs. (0.4%).
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Preoperative intravenous iron to treat anaemia before major abdominal surgery (PREVENTT): a randomised, double-blind, controlled trial
Richards T, Baikady RR, Clevenger B, Butcher A, Abeysiri S, Chau M, Macdougall IC, Murphy G, Swinson R, Collier T, et al
Lancet (London, England). 2020
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Editor's Choice
Abstract
BACKGROUND Preoperative anaemia affects a high proportion of patients undergoing major elective surgery and is associated with poor outcomes. We aimed to test the hypothesis that intravenous iron given to anaemic patients before major open elective abdominal surgery would correct anaemia, reduce the need for blood transfusions, and improve patient outcomes. METHODS In a double-blind, parallel-group randomised trial, we recruited adult participants identified with anaemia at preoperative hospital visits before elective major open abdominal surgery at 46 UK tertiary care centres. Anaemia was defined as haemoglobin less than 130 g/L for men and 120 g/L for women. We randomly allocated participants (1:1) via a secure web-based service to receive intravenous iron or placebo 10-42 days before surgery. Intravenous iron was administered as a single 1000 mg dose of ferric carboxymaltose in 100 mL normal saline, and placebo was 100 mL normal saline, both given as an infusion over 15 min. Unblinded study personnel prepared and administered the study drug; participants and other clinical and research staff were blinded to treatment allocation. Coprimary endpoints were risk of the composite outcome of blood transfusion or death, and number of blood transfusions from randomisation to 30 days postoperatively. The primary analysis included all randomly assigned patients with data available for the primary endpoints; safety analysis included all randomly assigned patients according to the treatment received. This study is registered, ISRCTN67322816, and is closed to new participants. FINDINGS Of 487 participants randomly assigned to placebo (n=243) or intravenous iron (n=244) between Jan 6, 2014, and Sept 28, 2018, complete data for the primary endpoints were available for 474 (97%) individuals. Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group (risk ratio 1·03, 95% CI 0·78-1·37; p=0·84). There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group (rate ratio 0·98, 95% CI 0·68-1·43; p=0·93). There were no significant differences between the two groups for any of the prespecified safety endpoints. INTERPRETATION Preoperative intravenous iron was not superior to placebo to reduce need for blood transfusion when administered to patients with anaemia 10-42 days before elective major abdominal surgery. FUNDING UK National Institute of Health Research Health Technology Assessment Program.
PICO Summary
Population
Adults with preoperative anaemia before elective major open abdominal surgery (n= 487).
Intervention
Intravenous iron: 1000 mg dose of ferric carboxymaltose (n= 244).
Comparison
Placebo: 100 mL normal saline (n= 243).
Outcome
Death or blood transfusion occurred in 67 (28%) of the 237 patients in the placebo group and 69 (29%) of the 237 patients in the intravenous iron group. There were 111 blood transfusions in the placebo group and 105 in the intravenous iron group. There were no significant differences between the two groups for any of the prespecified safety endpoints.
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A randomized controlled trial of the effects of local tranexamic acid on mortality, rebleeding, and recurrent endoscopy need in patients with upper gastrointestinal hemorrhage
Karadas A, Dogan NO, Pinar SG, Yesil O, Pekdemir M, Yilmaz S, Yaka E
European journal of gastroenterology & hepatology. 2019
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Editor's Choice
Abstract
OBJECTIVE Tranexamic acid (TXA) is an antifibrinolytic agent used to control bleeding in different circumstances. We conducted a randomized controlled trial to assess the efficacy and safety of locally administered TXA in upper gastrointestinal hemorrhage. METHODS This single-center, double-blind, randomized controlled trial was performed in a tertiary emergency department (ED) in patients presenting with upper gastrointestinal bleeding symptoms between 2016 and 2018. The patients received either 2000 mg of 5% TXA in 100 mL of isotonic saline solution or 100 mL isotonic saline (control group) via the nasogastric route. As a composite outcome, recurrent endoscopy need, rebleeding, surgery need, recurrent admission to the ED, and mortality parameters were evaluated at the end of a one-month period. RESULTS During the study period, 78 patients were randomized into the TXA group, and 79 patients were randomized into the isotonic saline group. The majority of the bleedings (61%) were in Forrest class 3, and the most frequent cause was peptic ulcer disease. The composite outcome occurred in 25 of the TXA patients (32.1%) and 23 of the isotonic saline patients (29.1%); no statistically significant difference was found between the groups (P = 0.690). In addition, no statistically significant differences were observed between the TXA and control groups regarding mortality (10.3 vs 12.7%; P = 0.637), recurrent ED admission (17.9 vs 12.7%; P = 0.357), or thromboembolic complications (3.8 vs 1.3%; P = 0.367). CONCLUSION Locally administered TXA confers no additional benefit over standard care in patients with upper gastrointestinal hemorrhage.
PICO Summary
Population
Patients presenting with upper gastrointestinal bleeding symptoms in a tertiary emergency department.
Intervention
TXA group: 2000 mg of 5% TXA in 100 mL of isotonic saline solution (n=78).
Comparison
Control group: 100 mL isotonic saline (n=79).
Outcome
The composite outcome occurred in 25 of the TXA patients (32.1%) and 23 of the isotonic saline patients (29.1%); no statistically significant difference was found between the groups. No statistically significant differences were observed between the TXA and control groups regarding mortality (10.3 vs 12.7%), recurrent ED admission (17.9 vs 12.7%), or thromboembolic complications (3.8 vs 1.3%).
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The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study
Bonnet A, Gilquin N, Steer N, Gazon M, Quattrone D, Pradat P, Maynard M, Mabrut JY, Aubrun F
European journal of anaesthesiology. 2019;36(11):825-833
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Editor's Choice
Abstract
BACKGROUND Orthotopic liver transplantation is associated with a risk of bleeding. Coagulation in cirrhotic patients is difficult to assess with standard coagulation tests because of rebalanced coagulation. This can be better assessed by thromboelastometry which can detect coagulation impairments more specifically in such patients. OBJECTIVES Our first objective was to compare the number of units of blood products transfused during liver transplantation when using an algorithm based on standard coagulation tests or a thromboelastometry-guided transfusion algorithm. DESIGN Randomised controlled trial. SETTING Single-centre tertiary care hospital in France, from December 2014 to August 2016. PARTICIPANTS A total of 81 adult patients undergoing orthotopic liver transplantation were studied. Patients were excluded if they had congenital coagulopathies. INTERVENTION Transfusion management during liver transplantation was guided either by a standard coagulation test algorithm or by a thromboelastometry-guided algorithm. Transfusion, treatments and postoperative outcomes were compared between groups. MAIN OUTCOME MEASURES Total number of transfused blood product units during the operative period (1 U is one pack of red blood cells (RBCs), fresh frozen plasma (FFP) or platelets). RESULTS Median [interquartile range] intra-operative transfusion requirement was reduced in the thromboelastometry group (3 [2 to 4] vs. 7 [4 to 10] U, P = 0.005). FFP and tranexamic acid were administered less frequently in the thromboelastometry group (respectively 15 vs. 46.3%, P = 0.002 and 27.5 vs. 58.5%, P = 0.005), whereas fibrinogen was more often infused in the thromboelastometry group (72.5 vs. 29.3%, P < 0.001). Median transfusions of FFP (3 [2 to 6] vs. 4 [2 to 7] U, P = 0.448), RBCs (3 [2 to 5] vs. 4 [2 to 6] U, P = 0.330) and platelets (1 [1 to 2] vs. 1 [1 to 2] U, P = 0.910) were not different between groups. In the postoperative period, RBC or platelet transfusion, the need for revision surgery or occurrence of haemorrhage were not different between groups. CONCLUSION A transfusion algorithm based on thromboelastometry assessment of coagulation reduced the total number of blood product units transfused during liver transplantation, particularly FFP administration. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02352181.
PICO Summary
Population
Adult patients undergoing orthotopic liver transplantation (n=81).
Intervention
Transfusion management during liver transplantation was guided by a standard coagulation test algorithm.
Comparison
Transfusion management during liver transplantation was guided by a thromboelastometry-guided algorithm.
Outcome
Median [interquartile range] intra-operative transfusion requirement was reduced in the thromboelastometry group (3 [2 to 4] vs. 7 [4 to 10] U). FFP and tranexamic acid were administered less frequently in the thromboelastometry group (respectively 15 vs. 46.3% and 27.5 vs. 58.5%), whereas fibrinogen was more often infused in the thromboelastometry group (72.5 vs. 29.3%). Median transfusions of FFP (3 [2 to 6] vs. 4 [2 to 7] U, RBCs (3 [2 to 5] vs. 4 [2 to 6] U) and platelets (1 [1 to 2] vs. 1 [1 to 2] U) were not different between groups. In the postoperative period, RBC or platelet transfusion, the need for revision surgery or occurrence of haemorrhage were not different between groups. (1 U is one pack of red blood cells (RBCs), fresh frozen plasma (FFP) or platelets).