1.
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.
2.
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.
3.
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.
4.
Fibrinogen substitution improves whole blood clot firmness after dilution with hydroxyethyl starch in bleeding patients undergoing radical cystectomy: a randomized, placebo-controlled clinical trial
Fenger-Eriksen C, Jensen TM, Kristensen BS, Jensen KM, Tønnesen E, Ingerslev J, Sørensen B
Journal of Thrombosis and Haemostasis. 2009;7((5):):795-802.
Abstract
SUMMARY BACKGROUND Infusion of artificial colloids such as hydroxyethyl starch (HES) induces coagulopathy to a greater extent than simple dilution. Several studies have suggested that the coagulopathy could be corrected by substitution with a fibrinogen concentrate. OBJECTIVES The aims of the present prospective, randomized, placebo-controlled trial were to investigate the hemostatic effect of a fibrinogen concentrate after coagulopathy induced by hydroxyethyl starch in patients experiencing sudden excessive bleeding during elective cystectomy. METHODS Twenty patients were included. Blood loss was substituted 1:1 with HES 130/0. 4. At a dilution level of 30%, patients were randomly selected for intra-operative administration of a fibrinogen concentrate or placebo. The primary endpoint was maximum clot firmness (MCF), as assessed by thromboelastometry. Secondary endpoints were blood loss and transfusion requirements, other thromboelastometry parameters, thrombin generation and platelet function. RESULTS Whole-blood MCF was significantly reduced after 30% dilution in vivo with HES. The placebo resulted in a further decline of the MCF, whereas randomized administration of fibrinogen significantly increased the MCF. Furthermore, only 2 out of 10 patients randomly chosen to receive fibrinogen substitution required postoperative red blood cell transfusions, compared with 8 out of 10 in the placebo group (P = 0. 023). Platelet function and thrombin generation were reduced after 30% hemodilution in vivo, and fibrinogen administration caused no significant changes. CONCLUSIONS During cystectomy, fluid resuscitation with HES 130/0. 4 during sudden excessive bleeding induces coagulopathy that shows reduced whole-blood maximum clot firmness. Randomized administration of fibrinogen concentrate significantly improved maximum clot firmness and reduced the requirement for postoperative transfusion.