Hemostatic effect of topical hemocoagulase spray in digestive endoscopy

AIM: To evaluate the hemostatic effect of topical hemocoagulase spray in digestive endoscopy.METHODS: Eighty-nine patients who developed oozing bleeding during endoscopic treatment from September 2014 to October 2014 at Center for Digestive Endoscopy, Tianjin Medical University General Hospital were randomly divided into either a study group(n = 39) or a control group(n = 50). The study group was given topical hemocoagulase spray intraoperatively, while the control group was given traditional 8% norepinephrine spray. Hemostatic efficacy was compared between the two groups. Bleeding site, wound cleanliness and perforation were recorded, and the rates of perforation and late bleeding were compared.RESULTS: Successful hemostasis was achieved in 39(100%) patients of the study group and in 47(94.0%) patients of the control group, and there was no significant difference in the rate of successful hemostasis between the two groups. Compared with the control group, after topical hemocoagulase spray in the study group, the surgical field was clearer, the bleeding site was more easily identified, and the wound was cleaner. There was no significant difference in the rate of perforation between the study and control groups(16.7% vs 35.0%, P = 0.477), but the rates oflate bleeding(0% vs 15.8%, P = 0.048) and overall complications(P = 0.032) were significantly lower in the study group.CONCLUSION: Topical hemocoagulase spray has a definite hemostatic effect for oozing bleeding in digestive endoscopy, and this method is convenient, safe, and reliable. It is expected to become a new method for endoscopic hemostasis.

Hypofibrinogenemia Caused by Hemocoagulase Injection:A Retrospective Study on Clinical Laboratory Findings

Objective Hemocoagulase injection based on the venom of Agkistrodon halys Pallas is widely used in the treatment of hemorrhagic disorders.This study aimed to characterize the clinical laboratory findings of hemocoagulase-induced hypofibrinogenemia as the associated adverse reaction of hemocoagulase injection.Methods Wie retrospectively enrolled 27 in-patients who were treated with hemocoagulase injection for hemoptysis and developed hypofibrinogenemia during the period of January 1,2015 to March 31,2018.Clinical data were collected and investigated,including clinical manifestations,hemostatic and fibrinolytic parameters,dosage of hemocoagulase,the medication time,and the cryoprecipitate blood product infusion.Differences in fibrinogen,D-dimer,and fibrin/fibrinogen degradation products(FDP)before,during,and after the application of hemocoagulase injection were analyzed statistically.Results Plasma fibrinogen level during medication of hemocoagulase injection decreased significantly compared to that before the treatment(F=1.80,P<0.001),with the average decrease of 2.28 g/L(0.63-3.9 g/L).After withdrawal,fibrinogen level increased significantly compared to that during the medication(F=l.20,P<0.001),but was still lower than that before the medication(F=0.59,P=0.03).The D-dimer level and the FDP level after withdrawal decreased significantly compared to the levels during the medication(F=0.83,P=0.002;Wilcoxon-test,Z=-4.54,P<0.001).Spearman's correlation analyses did not find either fibrinogen change during-before the administration or FDP change after-during the administration was associated with the dosage of hemo coagulase(r=-0.17,P=0.40;r=-0.28,P=0.15;respectively)and the time of recovery from hypofibrinogenemia(r=-0.45,P=0.05;r=0.13,P=0.61;respectively).Conclusion Monitoring both clotting and fibrinolysis parameters is essential in the management of hemoptysis patients treated with hemocoagulase injection.Clinicians should be aware of hypofibrinogenemia and consider discontinuation of the administration of hemocoagulase whenever necessary.

Hemocoagulase Injection blood anesthesia in joint operation

Objective:To investigate the role of Hemocoagulase Injection used in the joint operation and the effect on the blood coagulable function.Methods:A total of 60 patients who undergoing joint operation in our hospital were randomly divided into two groups.Experiment group(Group A,n=30)was injected with 2 U Hemocoagulase Injection in 5 min before anesthesia induction.The contrast group(Group B,n=30)was treated with 0.9%normal saline in 5 min before anesthesia induction.Then common anesthesia was given to the two groups of patients.The venous blood was withdrawn for blood routine examination,thrombelastography and coagulable function at the time of pre-inducement, end of operation,and in 6 and 12 h after operation.The change of thrombelastograph and coagulable state were monitored during the whole surgery.And the volume of transfusion and hemorrhage between two groups was contrasted. Results:After the use of Hemocoagulase Injection,the operative time was shortened obviously(P<0.05).The volumes hemorrhage and transfusion was obviously smaller in Group A than in Group B(P<0.01).Hemocoagulase Injection did not influence fibrinogen and thrombelastograph of Group A(P>0.05).Conclusion:Hemocoagulase Injection can reduce the volumes of hemorrhage and transfusion and not influence the coagulable function.It is worth using in the joint operation.

The mechanism of combination with hemocoagulase and pantoprazole in upper gastrointestinal bleeding

Objective:Through the combination with hemocoagulase and pantoprazole on gastrointestinal bleeding, to observe the changes of serum BUN (blood urea nitrogen), LPO (LPO), NO (nitric oxide), TNF-α(TNF alpha), hs-CRP (high sensitivity C reactive protein) and cortisol levels, and to explore the mechanism of combination. Methods:110 cases of upper gastrointestinal bleeding in our hospital from January 2015 to September 2016 were selected and divided into the control group and the observation group, 55 cases for each group. Patients were treated with bed rest, fasting, intravenous nutrition, oxygen, and according to the individual situation actively supplement blood capacity, and the control group were treated with 40 mg intravenous pantoprazole treatment, 2 times/d;the patients in the observation group were treated with 2 kU hemocoagulase injection based on the treatment of control group, 2 times of intravenous injection per day, and all patients were treated for 3 d, and then the BUN, LPO, NO, TNF-α, hs-CRP and cortisol were detected. Results:(1) There were no significantly differences of the serum levels of BUN, LPO, and NO of the two groups before treatment (P>0.05). After treatment, the serum levels the two groups were significantly lower than before treatment, and LPO, BUN, and NO levels in the observation group were significantly better than the control group (P<0.05);(2) There were no significantly differences of the serum levels of TNF-α, hs-CRP, and cortisol of the two groups before treatment (P>0.05). After treatment, the serum levels in the two groups were significantly lower than before treatment, and TNF-α, hs-CRP, and cortisol levels in the observation group were significantly better than the control group (P<0.05). Conclusions:The treatment of patients with combined use of hemocoagulase and pantoprazole on gastrointestinal bleeding, can significantly improve the serum levels of BUN, LPO, NO, TNF-α, hs-CRP and cortisol levels, and further illustrates the synergistic effect of the combination, also shows that the combination of two drugs for patients with upper gastrointestinal bleeding can improve the symptoms of hemorrhage, reduce inflammation and stress, and improve the treatment effect.

A multicenter, phase III trial of hemocoagulase Agkistrodon： hemostasis, coagulation, and safety in patients undergoing abdominal surgery

Background Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients. Methods This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group （injected with hemocoagulase Agkistrodon at 2 U, n=-324） or a control group （injected with hemocoagulase Atrox, n=108）. The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups. Results The mean hemostatic time in the study group was （36.8±18.7） seconds; the hemorrhagic volume was （3.77±3.93） g; and the hemorrhagic volume per unit area was （0.091±0.125） g/cm2. In the control group, the corresponding values were （38.1±19.7） seconds, （4.00±4.75） g, and （0.095±0.101） g/cm2, respectively. No significant difference in values existed between the two groups （P 〉0.05）. Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related. Conclusions Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.

Study on the anaphylactic shock induced by hemocoagulase for injection based on logistic analysis

In the present study, we aimed to explore the influencing factors of anaphylactic shock caused by hemocoagulase for injection and to provide a scientific basis for clinical safe medication. The cases reports on the adverse reactions induced by hemocoagulase for injection were collected in Chinese and foreign literatures. The clinical characteristics and influencing factors of anaphylactic shock induced by hemocoagulase for injection were evaluated by logistic regression analysis. In this study, 87 articles including 108 cases(68 cases of anaphylactic shock) were collected. Univariate logistic regression indicated that allergic constitution, daily dose, combined anesthesia, first drug delivery, post-dose time and course of treatment were positively associated with the incidence of anaphylactic shock caused by hemocoagulase for injection(P<0.05). The six above-mentioned factors were included in the multivariate logistic stepwise regression analysis to exclude the effects of confounding factors, and the results suggested that allergic constitution(P = 0.048, OR = 8.242), combined anesthesia(P = 0.024, OR = 22.675) and post-dose time(P = 0.006, OR = 20.255) were associated with the incidence of anaphylactic shock caused by hemocoagulase for injection. The clinicians should pay much more attention to risk factors that may cause anaphylactic shock, such as allergic constitution, combined anesthesia and post-dose time. The clinical pharmacists should strengthen pharmaceutical monitoring and improve the safety of medication.

Percutaneous injection of hemostatic agents for active liver hemorrhage

BACKGROUND: Active hemorrhage arising from hepatic injury can be life-threatening and require immediate attention. At present, nonoperative management of abdominal solid organ injuries has become the usual method of care. The purpose of this study was to determine whether, hemocoagulase injection alone guided by contrast-enhanced ultrasonography (CEUS) could control active bleeding in rabbit liver. METHODS: The livers of 30 rabbits were punctured with an 18-gauge semiautomatic biopsy needle to create an active bleeding liver model, which was confirmed with CEUS. The animals were randomly divided into two groups: a treatment group (n=15) and a control group (n=15). In the treatment group, hemocoagulase was injected into the bleeding site under CEUS guidance. In the control group, the active bleeding site was treated with normal saline. When these treatment procedures had been performed, lactated Ringer's solution was given to both groups to maintain the mean arterial pressure at 70 mmHg for 1 hour. The intraperitoneal blood loss, hematocrit, mean heart rate, and macroscopic and microscopic examinations were analyzed at the end of the study. RESULTS: CEUS showed hypoechoic and anechoic perfusion defects in active bleeding liver models. Macroscopic and microscopic examinations also supported the results. After the hemocoagulase injection, the former bleeding site appeared on CEUS as an area devoid of contrast. The blood loss was lower in the treatment group than in the control group (38.0+/-16.6 ml versus 107.9+/-20.8 ml; t=10.172, P<0.05). The mean hematocrit value and the heart rate were higher in the treatment group than in the control group (hematocrit: 23.9+/-3.8% versus 18.8+/-4.1%; t=3.541, P<0.05; heart rate: 250+/-18 versus 223+/-15; t=4.551, P<0.01). CONCLUSION: Hemocoagulase injection alone under the guidance of CEUS is a simple and quick method to control blood loss in active liver bleeding.