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Blood volume and hemodynamics during treatment of major hemorrhage with Ringer solution, 5% albumin, and 20% albumin: a single-center randomized controlled trial
Jardot, F., Hahn, R. G., Engel, D., Beilstein, C. M., Wuethrich, P. Y.
Critical care (London, England). 2024;28(1):39
Abstract
BACKGROUND Volume replacement with crystalloid fluid is the conventional treatment of hemorrhage. We challenged whether a standardized amount of 5% or 20% albumin could be a viable option to maintain the blood volume during surgery associated with major hemorrhage. Therefore, the aim of this study was to quantify and compare the plasma volume expansion properties of 5% albumin, 20% albumin, and Ringer-lactate, when infused during major surgery. METHODS In this single-center randomized controlled trial, fluid replacement therapy to combat hypovolemia during the hemorrhagic phase of cystectomy was randomly allocated in 42 patients to receive either 5% albumin (12 mL/kg) or 20% albumin (3 mL/kg) over 30 min at the beginning of the hemorrhagic phase, both completed by a Ringer-lactate replacing blood loss in a 1:1 ratio, or Ringer-lactate alone to replace blood loss in a 3:1 ratio. Measurements of blood hemoglobin over 5 h were used to estimate the effectiveness of each fluid to expand the blood volume using the following regression equation: blood loss plus blood volume expansion = factor + volume of infused albumin + volume of infused Ringer-lactate. RESULTS The median hemorrhage was 848 mL [IQR: 615-1145]. The regression equation showed that the Ringer-lactate solution expanded the plasma volume by 0.18 times the infused volume while the corresponding power of 5% and 20% albumin was 0.74 and 2.09, respectively. The Ringer-lactate only fluid program resulted in slight hypovolemia (mean, - 313 mL). The 5% and 20% albumin programs were more effective in filling the vascular system; this was evidenced by blood volume changes of only + 63 mL and - 44 mL, respectively, by long-lasting plasma volume expansion with median half time of 5.5 h and 4.8 h, respectively, and by an increase in the central venous pressure. CONCLUSION The power to expand the plasma volume was 4 and almost 12 times greater for 5% albumin and 20% albumin than for Ringer-lactate, and the effect was sustained over 5 h. The clinical efficacy of albumin during major hemorrhage was quite similar to previous studies with no hemorrhage. TRIAL REGISTRATION ClinicalTrials.gov NCT05391607, date of registration May 26, 2022.
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Fibrinogen prophylaxis for reducing perioperative bleeding in patients undergoing radical cystectomy: A double-blind placebo-controlled randomized trial
Fathi M, Lashay A, Massoudi N, Nooraei N, Nik MA
Journal of clinical anesthesia. 2021;73:110373
Abstract
OBJECTIVE Excessive bleeding is an important complication of radical cystectomy. We aimed to assess whether preoperative administration of fibrinogen decreases perioperative bleeding and improves the outcome of radical cystectomy. DESIGN Double-blinded randomized trial with two parallel arms. SETTING The study was conducted in the department of surgery at a teaching hospital affiliated with a University of Medical Sciences. PATIENTS In total, 70 men undergoing radical cystectomy were randomized to fibrinogen (n = 35) and placebo-control groups. Mean (SD) age was 64.7 (7.4) years. INTERVENTIONS The intervention group received 2 g fibrinogen concentrate diluted in 100 ml distilled water, and the control group received 100 ml normal saline; both intravenously 15 ̶ 30 min before the start of the surgery. OUTCOME MEASURES The primary outcome was the amount of perioperative blood loss. The secondary outcomes were hemodynamic features and vital signs. MAIN RESULTS Fibrinogen significantly decreased the volume of blood loss (p < 0.001) and the total number of transfused packed-cell units per group (38 vs. 115 units); and compensated the decrease of HCO3 (p = 0.030), the mean arterial pressure (p < 0.001), hemoglobin O2 saturation (p = 0.001), heart rate (p < 0.001), and temperature (p < 0.001) throughout the surgery compared with the placebo. Patients in the fibrinogen group had shorter Intensive Care Unit (p = 0.001) and hospital (p < 0.001) stay. We did not find any adverse reaction in our patients receiving fibrinogen concentrate. CONCLUSION Fibrinogen concentrate reduces perioperative bleeding and the need for blood transfusion in radical cystectomy. It improves the outcomes of the surgery and decreases patients' length of stay in the healthcare system following radical cystectomy. REGISTRATION Iranian Registry of Clinical Trials (IRCT) http://www.irct.ir/, reference number: IRCT20191013045091N1. ETHICS CODE Shahid Beheshti University of Medical Sciences, reference number: IR.SBMU.RETECH.REC.1398.033.
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Effects of balanced hydroxyethyl starch 6% (130/0.4) and albumin 5% on clot formation and glycocalyx shedding: Subgroup analysis of a prospective randomized trial
Kammerer T, Hulde N, Speck E, Hubner M, Crispin A, Zwissler B, Conzen P, von Dossow V, Schafer ST, Hofmann-Kiefer K, et al
Thrombosis research. 2019;183:111-118
Abstract
BACKGROUND Intravenous fluids can impair coagulation and affect the endothelial glycocalyx, whereas glycocalyx shedding itself can cause an impairment of clot formation and firmness. We hypothesized that hydroxyethyl starch 6% (130/0.4) has a more distinct effect on coagulation and glycocalyx shedding than albumin 5%. METHODS Presented data derive from an exploratory subgroup analysis of a prospective randomized, single-blinded trial comparing albumin 5% versus balanced hydroxyethyl starch 6% (130/0.4). Patients between 46 and 85years undergoing cystectomy were included. Prothrombin time, plasma fibrinogen concentration, partial thromboplastin time, thrombelastometry and platelet function were analyzed before and after surgery. Glycocalyx components were assessed before and after surgery, 2 to 4h after surgery and at 1st and 3rd postoperative day. Primary outcome parameter was the change of thrombelastometric variables at the end of surgery. Further variables included calculated blood loss, infusion amount and transfusion rate. RESULTS 55 patients (albumin group n=28; hydroxyethyl starch group n=27) were included. Thrombelastometric variables were significantly more compromised in the hydroxyethyl starch than in the albumin group whereas platelet function, glycocalyx shedding, partial thromboplastin time, prothrombin time and fibrinogen were not different between groups. Mean intraoperative calculated blood loss was higher in the hydroxyethyl starch group (1557+/-825ml versus 1245+/-709ml; p=0.042). Transfusion requirements did not differ. CONCLUSION Rotational thrombelastometric variables were significantly more reduced when hydroxyethyl starch was used compared to albumin 5%. This effect was independent from a shedding of the endothelial glycocalyx. However, results presented here are from a subgroup analysis and must be considered with caution. Trial registration EudraCT number 2010-018343-34.
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Effect of Local Fibrinogen Administration on Postoperative Bleeding in Open Prostatectomy Surgery
Janatmakan F, Nassajian N, Sarkarian M, Ghandizadeh Dezfuli M, Salari A, Tabatabaei SK, Soltani F, Nassajian S
Anesthesiology and Pain Medicine. 2018;8((3)):e73983.
Abstract
Background: Open prostatectomy is still accompanied by some postoperative bleeding. Prescribing fibrinogen to promote clot formation in patients with bleeding is of critical importance. This research studied the effects of local injection of fibrinogen on level of postoperative bleeding in open prostatectomy. Methods: Overall, 44 patients were randomly entered in a study on open prostatectomy. Patients in the intervention group received local injections of 500 mg fibrinogen (20 mL) dissolved in distilled water, and the control group patients only received 20 mL of normal saline, where the injections were given by the surgeon at the prostatectomy operation site. All patients were tested for hemoglobin, hematocrit, PT, PTT, INR, and fibrinogen level. Also, the amount of blood loss and requirement for blood products were recorded. Results: The study groups showed no difference regarding baseline variables. One patient in the fibrinogen group (1.66%) and four patients in the control group (6.66%) received blood products (P < 0.05), and the blood drainage tube at 24 hours after operation was 36.50) 18.70 (mL in the fibrinogen group and 151.36) 120.58 (mL in the control group (P = 0.005). There were no differences in hemoglobin, hematocrit, PT, PTT, INR, and serum fibrinogen level between the groups at any time. Conclusions: The current study demonstrated that using fibrinogen in patients with high bleeding risk may effectively reduce the amount of bleeding and its subsequent blood transfusion requirement, after open prostatectomy surgery.
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No differences in renal function between balanced 6% hydroxyethyl starch (130/0.4) and 5% albumin for volume replacement therapy in patients undergoing cystectomy: a randomized controlled trial
Kammerer T, Brettner F, Hilferink S, Hulde N, Klug F, Pagel J, Karl A, Crispin A, Hofmann-Kiefer K, Conzen P, et al
Anesthesiology. 2017;128((1):):67-78
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Abstract
BACKGROUND The use of artificial colloids has declined in critical care, whereas they are still used in perioperative medicine. Little is known about the nephrotoxic potential in noncritically ill patients during routine surgery. The objective of this trial was to evaluate the influences of albumin 5% and balanced hydroxyethyl starch 6% (130/0.4) on renal function and kidney injury. METHODS One-hundred urologic patients undergoing elective cystectomy were randomly assigned for this prospective, single-blinded, controlled study with two parallel groups to receive either albumin 5% or balanced hydroxyethyl starch 6% (130/0.4) as the only perioperative colloid. The primary endpoint was the ratio of serum cystatin C between the last visit at day 90 and the first preoperative visit. Secondary endpoints were estimated glomerular filtration rate and serum neutrophil gelatinase-associated lipocalin until the third postoperative day and risk, injury, failure, loss, and end-stage renal disease criteria at postoperative days 3 and 90. RESULTS The median cystatin C ratio was 1.11 (interquartile range, 1.01 to 1.23) in the albumin and 1.08 (interquartile range, 1.00 to 1.20) in the hydroxyethyl starch group (median difference = 0.03; 95% CI, -0.09 to 0.08; P = 0.165). Also, there were no significant differences concerning serum cystatin C concentrations; estimated glomerular filtration rate; risk, injury, failure, loss, and end stage renal disease criteria; and neutrophil gelatinase-associated lipocalin. Infusion requirements, transfusion rates, and perioperative hemodynamics were similar in both groups. CONCLUSIONS With respect to renal function and kidney injury, this study indicates that albumin 5% and balanced hydroxyethyl starch 6% have comparable safety profiles in noncritically ill patients undergoing major surgery.
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The effect of fibrinogen concentrate on perioperative bleeding in transurethral resection of the prostate: a double blind placebo-controlled and randomized study
Soleimani M, Masoumi N, Nooraei N, Lashay A, Safarinejad MR
Journal of Thrombosis and Haemostasis : Jth. 2016;15((2):):255-262
Abstract
BACKGROUND Hemorrhage during transurethral resection of the prostate (TUR-P) has always been a concern. Several studies have shown that pre-operative administration of fibrinogen concentrate has promising results in reducing hemorrhage in cardiac surgery. OBJECTIVES This study investigated the hemostatic effect of fibrinogen concentrate administration on reducing the bleeding amount during TUR-P in patients with benign prostatic hyperplasia. METHODS Sixty men with benign prostatic hyperplasia, who were chosen to undergo TUR-P, entered this prospective randomized double-blind placebo-controlled pilot study. The participants were randomly assigned to two groups: treatment (n=31) and placebo (n=29). They received an infusion of 2 gr fibrinogen concentrate (treatment group) or normal saline (placebo group) before surgery. Data regarding bleeding amount, the operation and complications were recorded and analyzed. RESULTS No difference was observed in bleeding during (521 mL vs. 557 mL) and after (291 mL vs. 341 mL) the surgery between fibrinogen and placebo groups, respectively. This lack of difference was also seen in operation time (43 vs. 42 minutes), irrigating fluid volume used during (17 L vs. 19 L) and after operation (29 L vs. 28 L), and resected adenoma volume (19 gr vs. 19 gr). The mean blood pressure was also similar in both groups as a confounding factor in the bleeding amount. CONCLUSION Preoperative administration of fibrinogen concentrate had no significant influence on intra- and post-operative bleeding in TUR-P surgery. This article is protected by copyright. All rights reserved.
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Impact of albumin on coagulation competence and hemorrhage during major surgery: a randomized controlled trial
Rasmussen KC, Hojskov M, Johansson PI, Kridina I, Kistorp T, Salling L, Nielsen HB, Ruhnau B, Pedersen T, Secher NH
Medicine. 2016;95((9)):e2720.
Abstract
For patients exposed to a massive blood loss during surgery, maintained coagulation competence is important. It is less obvious whether coagulation competence influences bleeding during elective surgery where patients are exposed to infusion of a crystalloid or a colloid.This randomized controlled trial evaluates whether administration of 5% human albumin (HA) or lactated Ringer solution (LR) affects coagulation competence and in turn blood loss during cystectomy due to bladder cancer.Forty patients undergoing radical cystectomy were included to receive either 5% HA (n = 20) or LR (n = 20). Nineteen patients were analyzed in the HA group and 20 patients in the lactated Ringer group.Blinded determination of the blood loss was similar in the 2 groups of patients: 1658 (800-3300) mL with the use of HA and 1472 (700-4330) mL in the lactated Ringer group (P = 0.45). Yet, by thrombelastography (TEG) evaluated coagulation competence, albumin affected clot growth (TEG-angle 69 +/- 5 vs 74 degrees +/- 3 degrees , P < 0.01) and strength (TEG-MA: 59 +/- 6 vs 67 +/- 6 mm, P < 0.001) more than LR. Furthermore, by multivariate linear regression analyses reduced TEG-MA was independently associated with the blood loss (P = 0.042) while administration of albumin was related to the changes in TEG-MA (P = 0.029), aPPT (P < 0.022), and INR (P < 0.033).This randomized controlled trial demonstrates that administration of HA does not affect the blood loss as compared to infusion of LR. Also the use of HA did not affect the need for blood transfusion, the incidence of postoperative complications, or the hospital in-stay. Yet, albumin decreases coagulation competence during major surgery and the blood loss is related to TEG-MA rather than to plasma coagulation variables.
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Effect of perioperative colloid and crystalloid fluid therapy on coagulation competence, haemorrhage and outcome
Rasmussen KC
Danish Medical Journal. 2016;63((9))
Abstract
BACKGROUND Haemorrhage follows surgical intervention, but also fluid substitution may affect the blood loss. Here influence of colloids and lactated Ringer's solution (LR) on coagulation competence and haemorrhage is evaluated during cystectomy. METHODS A meta-analysis, a prospective observational study and three randomized controlled trials were conducted - 17 patients received HES 130/0.4, 19 patients Dextran 70, 19 patients human albumin, and 54 patients LR - with blinded evaluation of blood loss and outcome while coagulation competence was evaluated by thromboelastography (TEG) and plasma coagulation analyses. RESULTS Administration of HES reduced TEG determined "maximal amplitude" (TEG-MA) from 64+/-6 to 52+/-7 mm associated with a 2181+/-1190 mL blood loss. For Dextran values were 65+/-7 to 49+/-9 mm and 2339+/-1471 mL, respectively, for albumin 62+/-6 to 59+/-6 mm and 1658+/-684 mL compared to 65+/-6 to 64+/-6 mm and 1559+/-976 mL with the use of LR. Furthermore, reduced TEG-MA was independently associated with the perioperative blood loss. A straight postoperative course was seen less often after infusion of synthetic colloids versus albumin/LR (7/36 vs. 31/73), P=0.02. CONCLUSIONS Perioperative bleeding is related to administration of Dextran 70 followed by HES 130/0.4 whereas albumin and LR result in a similar low level of haemorrhage. Furthermore, evaluation of coagulation competence by TEG-MA appears superior to plasma coagulation analyses for predicting the perioperative blood loss and supports that haemorrhage depends not only on the surgical intervention but also on the perioperative fluid therapy of apparent consequence for outcome.
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Randomized, controlled, blinded trial of tisseel/tissucol for mesh fixation in patients undergoing Lichtenstein technique for primary inguinal hernia repair: results of the TIMELI trial
Campanelli G, Pascual MH, Hoeferlin A, Rosenberg J, Champault G, Kingsnorth A
Annals of Surgery. 2012;255((4):):650-7.
Abstract
Objective: Test the hypothesis that fibrin sealant mesh fixation can reduce the incidence of postoperative pain/numbness/groin discomfort by up to 50% compared with sutures for repair of inguinal hernias using the Lichtenstein technique. Background: Inguinal hernia repair is the most common procedure in general surgery, thus improvements in surgical techniques, which reduce the burden of undesirable postoperative outcomes, are of clinical importance. Methods: A randomized, controlled, patient- and evaluator-blinded study (Tissucol/Tisseel for MEsh fixation in LIchtenstein hernia repair [TIMELI]; trial NCT00306839) was conducted among patients eligible for Lichtenstein repair of uncomplicated unilateral primary inguinal small-medium sized hernia. Patients were subject to mesh fixation with either fibrin sealant or sutures. Main outcome measures were visual analogue scale (VAS) assessments for pain,numbness,and groin discomforton a scale of 0 = best and 100 = worst outcome. The primary endpoint was a composite that evaluated the prevalence of chronic disabling complications (VAS score >30 for pain/numbness/groin discomfort) at 12 months after surgery. Results: In total, 319 patients were randomized between January 2006 and April 2007 (159 fibrin sealant, 160 sutures). At 12 months, the prevalence of 1 or more disabling complication was significantly lower in the fibrin sealant group than in the sutures group (8.1% vs 14.8%; P = 0.0344). Less pain was reported in the fibrin sealant group than in the sutures group at 1 and 6 months (P = 0.0132; P = 0.0052), as reflected by a lower proportion of patients using analgesics in the fibrin group over the study duration (65.2% vs 79.7%; P = 0.0009). Only 3 of 316 patients (0.9%) experienced recurrence. The incidences of wound-healing complications and other adverse events were comparable between groups. Conclusions: Fibrin sealant for mesh fixation in Lichtenstein repair of small-medium sized inguinal hernias is well tolerated and reduces the rate of pain/numbness/groin discomfort by 45% relative to sutures without increasing hernia recurrence (NCT00306839). (C) 2012 Lippincott Williams & Wilkins, Inc.
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Comparison of self-gripping mesh with mesh fixation with fibrin-glue in laparoscopic hernia repair (TAPP)
Cambal M, Zonca P, Hrbaty B
Bratislavské Lekarske Listy. 2012;113((2):):103-7.
Abstract
AIM: Comparison of self-gripping mesh with fibrin-glue mesh fixation for laparoscopic hernia repair using TAPP technique. MATERIALS AND METHODS The trial has a prospective randomized design. The primary end-point was the evaluation of pain at 2 days, 1 month, and 3 months after surgery. The pain occurring 3 months after the surgery was considered as chronic pain. RESULTS We have compared a group of 50 patients with self-gripping mesh with a group of 50 patients with fibrin glue mesh fixation using TAPP technique. There was no statistical difference between the basic group parameters (sex distribution, average age). There was no significant difference between the groups in terms of postoperative pain 1 month and 3 months after the surgery (p>0.05). There was no patient with chronic pain at 3-month follow-up in our trial. The mean operation time was 44 minutes in the group with self-gripping mesh and 48.5 minutes in the group with fibrin glue mesh fixation. There was a significant difference between both groups (p=0.006) CONCLUSION Both fixation methods appear to be a well-tolerated alternative to classical methods for mesh fixation with clips. According to our trial there is no difference in the postoperative pain incidence in self-gripping mesh and fibrin glue mesh fixation groups for laparoscopic hernia repair. Our data has showed that self-gripping mesh represents a tendency to a faster technique in comparison with fibrin-glue fixation. Both techniques are easy-to-use. There is no superior technique according to our trial (Tab. 2, Fig. 2, Ref. 23).