Fibrinogen prophylaxis for reducing perioperative bleeding in patients undergoing radical cystectomy: A double-blind placebo-controlled randomized trial
Journal of clinical anesthesia. 2021;73:110373
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.
Efficacy of fibrin sealant as waterproof cover in improving outcome in hypospadias surgery
African journal of paediatric surgery : AJPS. 2021;18(4):215-218
BACKGROUND This prospective comparative study aims to assess the efficacy of fibrin sealant to improve outcomes in paediatric patients operated for hypospadias. MATERIALS AND METHODS Forty consecutive patients with hypospadias were randomised into two groups of twenty patients each. The first group underwent hypospadias repair, technique depending on the type of hypospadias, whereas in the second group, fibrin sealant was used to reinforce the urethroplasty. Assessment was done with respect to the type of hypospadias, type of repair done, operative time, immediate post-operative complications (early ooze and skin flap-related complications), intermediate complications (urethra-cutaneous fistula) and delayed post-operative complications (penile torsion and poor cosmetic outcome) at follow-up. We also compared the overall improvement in outcome among the two groups. RESULTS First Group: The mean operative time was 1 h and 45 min. Complications were seen in nine patients: Early ooze (n = 2); skin flap-related complications (n = 3); fistula (n = 7); poor cosmetic outcome (n = 7) and penile torsion (n = 4). Second Group (Fibrin Sealant): The mean operative time was 1 h and 30 min. Post-operative complications were observed in five patients: Coronal fistula (n = 3) and poor cosmetic outcome (n = 3). On comparing, the differences in outcomes of ooze, skin flap-related complications and torsion were found to be statistically significant with P < 0.05. The differences in the urethra-cutaneous fistula and cosmetic appearance were not found to be statistically significant. The difference in overall improvement in complications was found to be statistically significant. CONCLUSION Fibrin sealant, when applied over the urethroplasty suture line as a waterproof cover, may help to improve the outcome in patients with hypospadias.
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
Thrombosis research. 2019;183:111-118
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.
Effect of Local Fibrinogen Administration on Postoperative Bleeding in Open Prostatectomy Surgery
Anesthesiology and Pain Medicine. 2018;8((3)):e73983.
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.
Efficacy of a fibrin sealant (Tissucol Duo(R)) for the prevention of lymphocele after laparoscopic pelvic lymphadenectomy: a randomised controlled trial
Journal of Minimally Invasive Gynecology. 2018
STUDY OBJECTIVE To assess the efficacy of Tissucol Duo(R) (Baxter AG) fibrin sealant in decreasing the incidence of lymphocele (LC) after pelvic laparoscopic lymph node dissection using harmonic shears. DESIGN CLASSIFICATION Randomized controlled trial (Canadian Task Force Classification level I) SETTING Tertiary referral and educational center. PATIENTS A double blind randomized controlled study was conducted (February 2012-June 2016) including 74 patients randomizing the use of sealant per hemipelvis. INTERVENTION Following bilateral pelvic lymphadenectomy, a fibrin sealant was used in one hemipelvis but not the other, being applied in 41 (55.4%) left and 33 (44.6%) right hemipelvises. The primary outcome was the incidence of LC after surgery in symptomatic and asymptomatic patients. Imaging (ultrasound, computed tomography and magnetic resonance) was performed to detect LC at 3, 6 and 12 months after surgery.
The efficacy of fibrin glue injection in the prostatic fossa on decreasing postoperative bleeding following transurethral resection of prostate
Advanced Biomedical Research. 2016;5:161
BACKGROUND To evaluate the efficacy of fibrin glue injection in the prostatic fossa at the end of transurethral resection of prostate (TURP), in decreasing postoperative bleeding in patient with benign prostatic hyperplasia (BPH). MATERIALS AND METHODS In this prospective randomized clinical trial, sixty patients with BPH, who were a candidate for TURP, were randomly divided into two equal groups. In the intervention group, 10cc of fibrin glue was injected in the prostatic fossa at the end of the surgery; through a 5 Fr feeding tube attached to Foley catheter and its tip was proximal to the balloon of catheter. The other thirty patients created the control group. Hemoglobin (Hb) level and lower urinary tract symptoms (LUTS) score were recorded before and 6, 24, 48 h, and 5 days after TURP. RESULTS The mean age of the patients and prostate volumes were comparable between the groups. The mean Hb level before and 6 h after TURP were not different between the two groups, however, 24 and 48 h and 5 days after TURP, there was a significant difference as well as a higher decrease in the mean Hb level of the control group (P = 0.023). The mean LUTS score was not statistically different between the two groups. CONCLUSION Fibrin glue injection in the prostatic after TURP reduces postoperative bleeding without any effect on LUTS score in patients with BPH.
Effect of perioperative colloid and crystalloid fluid therapy on coagulation competence, haemorrhage and outcome
Danish Medical Journal. 2016;63((9))
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.
Use of fibrin glue as a sealant at the anastomotic line in laparoscopic pyeloplasty: a randomised controlled trial
Arab Journal of Urology Print. 2016;14((94):):292-298.
OBJECTIVE To assess the effectiveness of fibrin glue as a sealant at the anastomotic line of a stentless laparoscopic pyeloplasty (LPP) repair instead of JJ stent insertion. PATIENTS AND METHODS In all, 46 patients with pelvi-ureteric junction obstruction scheduled for LPP were randomised into two groups each containing 23 patients. Group A underwent stented repair, while group B had a stentless repair together with sealing of the anastomotic line with fibrin glue. RESULTS There was no statistically significant difference between the groups for the postoperative improvement in the renal scan and intravenous urography. However, there was a statistically significant decrease in early postoperative adverse events in group B. In group A, all the patients had irritative lower urinary tract symptoms (LUTS) and 16 (72.7%) had postoperative urinary tract infections (UTIs). In group B, no patient had a UTI or irritative LUTS. In all, 21 patients (95.4%) in group A had minimal terminal painful haematuria; while in group B, only one patient (4.3%) had minimal total painless haematuria. Also, patients in group B were spared the need for a second anaesthesia exposure for stent removal. CONCLUSION The use of fibrin glue is a valid alternative to stenting in LPP with the same excellent outcome but with markedly lower short-term postoperative adverse events. IS 2090-598X IL 2090-598X
Impact of albumin on coagulation competence and hemorrhage during major surgery: a randomized controlled trial
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.
The effect of fibrinogen concentrate on perioperative bleeding in transurethral resection of the prostate: a double blind placebo-controlled and randomized study
Journal of Thrombosis and Haemostasis : Jth. 2016;15((2):):255-262
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.