Efficacy and Safety of Bioabsorbable Bone Hemostatic Agent in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2021;27:10760296211023589
Although a bioabsorbable bone hemostatic agent (BBHA) was developed approximately 20 years ago to overcome the shortcomings of conventional bone wax, its bleeding control capacity has not yet been studied. This study was aimed at investigating the efficacy and safety of BBHA in total knee arthroplasty (TKA). Sixty-two patients who underwent unilateral primary TKA for knee osteoarthritis were included and randomized to the control or BBHA group. Before releasing the tourniquet, BBHA was applied on the bone-cut surface that was not covered by implants. The primary variable was the drainage volume during the postoperative period. The secondary outcomes were total estimated blood loss (EBL), hemoglobin level, hematocrit level, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level, range of motion (ROM), pain visual analog scale (VAS) score, and rate of complications. There were no significant differences in drainage volume or EBL between the 2 groups. Hemoglobin and hematocrit levels were higher in the BBHA group during the 4-week postoperative period; however, the intergroup differences were not significant. The ESR, CRP, ROM, and pain VAS scores in the BBHA group were not significantly different from the corresponding values in the control group. No specific complications were observed. Although BBHA was found to be safe without complications, it did not decrease bleeding after TKA in general cases. Further studies are necessary to evaluate the efficacy of BBHA in patients with coagulation problems.
Incidence of venous thromboembolism and hemorrhage in Chinese patients after pulmonary lobectomy: mechanical prophylaxis or mechanical prophylaxis combined with pharmacological prophylaxis: a randomized controlled trial
Annals of translational medicine. 2021;9(18):1478
BACKGROUND Venous thromboembolism (VTE) and postoperative bleeding are important complications of lung resection surgery. We investigated the preventive effect of mechanical prophylaxis versus pharmacological prophylaxis after lobectomy, and evaluated the effect of both on the incidence of hemorrhagic events. METHODS A prospective study of 424 lobectomies with moderate to high risk of VTE (Caprini risk score <5) in a single center was performed from April 2020 to March 2021. Patients were 1:1 randomly allocated to mechanical prophylaxis or to the low-molecular-weight heparin (LMWH)-combination-prophylaxis. The incidence of postoperative thrombotic and bleeding events and relevant factors of the two groups were analyzed. RESULTS A total of 410 participants, with 202 and 208 in the mechanical prophylaxis and LMWH-combination-prophylaxis groups respectively, were selected for analysis. Both groups had similar baseline and clinical characteristics. There were no cases of VTE or major bleeding during the study, but the incidence rate of minor bleeding in the LMWH-combination-prophylaxis group was significantly higher than mechanical prophylaxis group [odds ratio (OR) 0.035, 95% confidence interval (CI): 0.011-0.113]. CONCLUSIONS A case-by-case risk assessment of VTE and hemorrhage remains necessary to determine the most appropriate method of thrombosis prophylaxis for patients undergoing pulmonary surgery. Mechanical prophylaxis may be preferable for lung cancer patients with moderate to high risk of VTE (Caprini risk score <5) undergoing lobectomy. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR2100051073.
Application of enhanced recovery after surgery in total knee arthroplasty in patients with haemophilia A: A pilot study
Nursing open. 2021;8(1):80-86
AIM: To identify the effect of enhanced recovery after surgery (ERAS) and rapid rehabilitation concepts on the outcomes of patients with haemophilia A undergoing total knee arthroplasty. DESIGN Randomized controlled trial. METHODS The primary endpoint was postoperative hospital stay. The secondary endpoints were pain scores, joint function scores, haemoglobin levels at 3 and 7 days after surgery and satisfaction with hospitalization. RESULTS Thirty-two patients were enrolled. Compared with the routine nursing group, the ERAS group showed shorter postoperative hospital stay (14.2 SD 0.8 vs. 16.6 ± 1.3 days, p < .001), smaller amounts of blood transfusion (924 SD 317 vs. 1,263 SD 449 ml, p = .020) and coagulation factors (37,325 SD 5,996 vs. 48,475 SD 8,019 U, p < .001), lower pain scores at 3 (3.3 SD 0.7 vs. 4.3 SD 0.7, p = .002) and 7 (2.3 SD 0.7 vs. 2.8 ± 0.5, p = .015) days, lower hospital for special surgery knee scores at 3 (59.9 SD 7.8 vs. 53.6 SD 5.9, p = .016) and 7 (77.9 SD 6.9 vs. 71.1 ± 7.1, p = .009) days and higher satisfaction with hospitalization (94.3 SD 1.4 vs. 92.7 SD 1.6, p = .004).
Effect of flowable thrombin-containing collagen-based hemostatic matrix for preventing pancreatic fistula after pancreatectomy: A randomized clinical trial
Annals of hepato-biliary-pancreatic surgery. 2021;25(Suppl 1):S371
INTRODUCTION The aim of this study was to evaluate the safety and efficacy of a flowable hemostatic matrix, and their effect for postoperative pancreatic fistula (POPF) after pancreatectomy. METHODS This was a randomized, clinical, single-center, single-blind (participant), non-inferiority, phase IV, and parallel-group trial. The primary endpoint was the incidence of POPF. The secondary endpoints were risk factors for POPF, drain removal days, incidence of complication, 90-day mortality, and length of hospital stay. RESULTS This study evaluated a total of 54 patients, with 26 patients in the intervention group (flowable hemostatic matrix) and 27 patients in the control group (thrombin-coated collagen patch). POPF was more common in the control group than in the intervention group (59.3% vs. 30.8%, p = 0.037). Among participants who underwent distal pancreatectomy (DP), POPF (33.3% vs. 92.3%, p = 0.004) and clinically relevant POPF (8.3% vs. 46.2%, p = 0.027) were more common in the control group. A multivariate logistic regression model identified flowable hemostatic matrix use (p = 0.029) as an independent negative risk factor for POPF. CONCLUSIONS Flowable hemostatic matrix application is a simple, feasible, and effective method of preventing POPF after pancreatectomy, especially for patients with DP.
Effect of carbazochrome sodium sulfonate combined with tranexamic acid on blood loss and inflammatory response in patients undergoing total hip arthroplasty
Bone & joint research. 2021;10(6):354-362
AIMS: The purpose of this study was to examine the efficacy and safety of carbazochrome sodium sulfonate (CSS) combined with tranexamic acid (TXA) on blood loss and inflammatory responses after primary total hip arthroplasty (THA), and to investigate the influence of different administration methods of CSS on perioperative blood loss during THA. METHODS This study is a randomized controlled trial involving 200 patients undergoing primary unilateral THA. A total of 200 patients treated with intravenous TXA were randomly assigned to group A (combined intravenous and topical CSS), group B (topical CSS), group C (intravenous CSS), or group D (placebo). RESULTS Mean total blood loss (TBL) in groups A (605.0 ml (SD 235.9)), B (790.9 ml (SD 280.7)), and C (844.8 ml (SD 248.1)) were lower than in group D (1,064.9 ml (SD 318.3), p < 0.001). We also found that compared with group D, biomarker level of inflammation, transfusion rate, pain score, and hip range of motion at discharge in groups A, B, and C were significantly improved. There were no differences among the four groups in terms of intraoperative blood loss (IBL), intramuscular venous thrombosis (IMVT), and length of hospital stay (LOS). CONCLUSION The combined application of CSS and TXA is more effective than TXA alone in reducing perioperative blood loss and transfusion rates, inflammatory response, and postoperative hip pain, results in better early hip flexion following THA, and did not increase the associated venous thromboembolism (VTE) events. Intravenous combined with topical injection of CSS was superior to intravenous or topical injection of CSS alone in reducing perioperative blood loss. Cite this article: Bone Joint Res 2021;10(6):354-362.
The effect of pantoprazole and somatostatin combined with thrombin in the treatment of non-esophagogastric varicosity upper gastrointestinal bleeding
American journal of translational research. 2021;13(5):5484-5490
OBJECTIVE To explore the effect of pantoprazole and somatostatin combined with thrombin in the treatment of non-esophagogastric varicosity upper gastrointestinal bleeding (UGB) as well as its influence on serum hs-CRP and coagulation function. METHODS From June 2016 to May 2018, patients with upper gastrointestinal hemorrhage due to non-esophagogastric varices in our hospital were selected as research subjects. After screening, they were randomly divided into the combined group (57 cases) and the control group (57 cases). After the two groups are treated, the therapeutic effect was observed. The two groups of patients were followed up for 6 consecutive months, and the data were statistically analyzed. RESULTS It was found that there wass no significant difference between the two groups in gender, age, amount of bleeding, and etiology (P > 0.05). It was found that the immediate hemostasis rate and the hemostasis rate within 24 hours in the combined group were distinctly higher compared to the control group. The difference has statistical significance (P < 0.05). The total effective rate of the combined group was distinctly higher compared to the control group (P < 0.05). By comparing the expression levels of hs-CRP and IL-6 protein in the serum of the two groups before and after treatment, it was found that there was no significant difference in the expression levels of hs-CRP and IL-6 protein before treatment. However, after treatment, it was found that the levels of hs-CRP and IL-6 protein in the combined group were distinctly lower compared to the control group (P < 0.05). By analyzing adverse reactions, it was found that the combined group had distinctly lower adverse reactions compared to the control group (P < 0.05). CONCLUSION This work provides an experimental basis for the diagnosis and treatment of non-esophagogastric varicose UGB in the clinic.
Effects of carbazochrome sodium sulfonate combined with tranexamic acid on hemostasis and inflammation during perioperative period of total hip arthroplasty: a randomized controlled trial
Orthopaedics & traumatology, surgery & research : OTSR. 2021;:103092
BACKGROUND The hemostatic effect of tranexamic acid (TXA) combined with carbazochrome sodium sulfonate (CSS) in total hip arthroplasty (THA) has not been determined. Therefore we performed a randomized study aiming to evaluate the effects of CSS combined with TXA on perioperative blood loss and inflammatory response of THA. HYPOTHESIS CSS combined with TXA can effectively reduce perioperative blood loss and immune response compared to TXA. MATERIAL AND METHODS This randomized placebo-controlled trial assigned 150 patients undergoing unilateral primary total hip arthroplasty who underwent direct anterior approach surgery to 3 groups: group A received TXA plus topical CSS; group B received TXA only; and group C received placebo. The main outcome was total blood loss. Secondary outcomes included reduction in hemoglobin concentration, coagulation parameters, inflammatory marker levels, perioperative visual analog scale (VAS) pain score, transfusion rates, postoperative hospital stay, and incidence of thromboembolic events. RESULTS Total blood loss in group A (668.84±230.95mL) was lower than in group B (940.96±359.22 mL) and C (1166.52±342.85 mL, p < 0.05). We also found that compared with group B, postoperative hip pain, biomarker level of inflammation, visual analogue score (VAS) pain score in group A were significantly improved. The transfusion rate and unit of group A were significantly lower than group C (8 patients ; 17.5 units), but there was no statistical difference between group A (no transfusion) and group B (2 patients; 4 units). No differences were observed in thromboembolic and other outcomes among the groups. DISCUSSION The combined application of topic CSS and TXA is more effective than TXA alone following THA in regard of reducing total blood loss. In addition, CSS combined with TXA is better than TXA alone in terms of improving postoperative hip pain and reducing the level of inflammatory factors. LEVEL OF EVIDENCE I; randomized controlled study.
Effect of remote ischemic preconditioning on cerebral vasospasm, biomarkers of cerebral ischemia, and functional outcomes in aneurysmal subarachnoid hemorrhage (ERVAS): A randomized controlled pilot trial
Brain circulation. 2021;7(2):104-110
BACKGROUND Cerebral vasospasm can complicate aneurysmal subarachnoid hemorrhage (aSAH), contributing to cerebral ischemia. We explored the role of remote ischemic preconditioning (RIPC) in reducing cerebral vasospasm and ischemia and improving outcomes after aSAH. MATERIALS AND METHODS Patients with ruptured cerebral aneurysm undergoing surgical clipping and meeting the trial criteria were randomized to true RIPC (n = 13) (inflating upper extremity blood pressure cuff thrice to 30 mmHg above systolic pressure for 5 min) or sham RIPC (n = 12) (inflating blood pressure cuff thrice to 30 mmHg for 5 min) after ethical approval. A blinded observer assessed outcome measures-cerebral vasospasm and biomarkers of cerebral ischemia. We also evaluated the feasibility and safety of RIPC in aSAH and Glasgow Outcome Scale-Extended (GOSE). RESULTS Angiographic vasospasm was seen in 9/13 (69%) patients; 1/4 patients (25%) in true RIPC group, and 8/9 patients (89%) in sham RIPC group (P = 0.05). Vasospasm on transcranial Doppler study was diagnosed in 5/25 (20%) patients and 1/13 patients (7.7%) in true RIPC and 4/12 patients (33.3%) in sham RIPC group, (P = 0.16). There was no difference in S100B and neuron-specific enolase (NSE) levels over various time-points within groups (P = 0.32 and 0.49 for S100B, P = 0.66 and 0.17 for NSE in true and sham groups, respectively) and between groups (P = 0.56 for S100B and P = 0.31 for NSE). Higher GOSE scores were observed with true RIPC (P = 0.009) unlike sham RIPC (P = 0.847) over 6-month follow-up with significant between group difference (P = 0.003). No side effects were seen with RIPC. CONCLUSIONS RIPC is feasible and safe in patients with aSAH and results in a lower incidence of vasospasm and better functional outcome.
Effectiveness of preoperative tranexamic acid in reducing blood loss during caesarean section at Aminu Kano Teaching Hospital, Kano: a randomized controlled trial
The Pan African medical journal. 2021;39:34
INTRODUCTION bleeding during and after caesarean section is one of the contributors to maternal mortality and morbidity. Tranexamic acid can be given before surgery to significantly reduce the amount of blood loss during caesarean section. The objective was to evaluate the effectiveness of preoperative tranexamic acid in reducing blood loss during caesarean section at Aminu Kano Teaching Hospital, Kano. METHODS this was a randomized double blind placebo controlled study that was carried out among 244 women who were to have emergency caesarean section between December 2017 and June 2018 and were randomly assigned to the study group or control group. Women in the study group received lg (10mls) of tranexamic acid intravenously while women in the control group received 10ml of normal saline. Oxytocin was administered in the two groups according to protocol. Measurement of blood loss was done immediately after surgery. Postoperative drop in haemoglobin and haematocrit were also determined. Statistical analysis was done using SPSS Version 22. RESULTS the average intra operative blood loss was 414.0 ml in the study group and 773.8 ml in the control group (t = - 16.18, p ≤ 0.01). Average postoperative haemoglobin was 10.1 g/dl in the study group and 9.5 g/dl in the control group (t = 4.99, p ≤ 0.01). Average postoperative haematocrit was 31.5% in the study group and 29.9% in the control group (t = 4.70, p ≤ 0.01). CONCLUSION there was a significant reduction in the blood loss when preoperative tranexamic acid was given to patients who were to undergo emergency caesarean section.
Women having emergency caesarean section in a single centre in Nigeria (n= 244).
Intravenous tranexamic acid (n= 122).
Normal saline (n= 122).
There was a significant reduction in blood loss when preoperative tranexamic acid compared to the normal saline. The average intra operative blood loss was 414.0 ml in the study group and 773.8 ml in the control group. Average postoperative haemoglobin was 10.1 g/dl in the study group and 9.5 g/dl in the control group. Average postoperative haematocrit was 31.5% in the study group and 29.9% in the control group.
Ovarian function following use of various hemostatic techniques during treatment for an endometrioma: A randomized controlled trial
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics. 2021
OBJECTIVE To compare the effect of hemostatic techniques (bipolar energy versus hemostatic sealants versus suture) on the ovarian reserve of patients submitted to laparoscopic cystectomy for the surgical excision of a unilateral endometrioma. METHODS A randomized controlled trial conducted in a teaching hospital included 84 patients with a unilateral endometrioma. The patients underwent laparoscopic stripping for excision of the unilateral endometrioma between March 2018 and February 2020. Three different hemostatic techniques - bipolar energy (Group 1), hemostatic sealants (Group 2) and suture (Group 3) - were compared. Anti-Müllerian hormone (AMH) levels were measured prior to and 1 and 6 months after surgery to determine changes in ovarian function. RESULTS Following surgery, AMH levels decreased in all the groups; however, this decrease was not statistically significant. Comparison between groups showed no statistically significant differences in AMH levels between the three hemostatic techniques used. Six months after surgery, median AMH levels were: 1.65 (interquartile range [IQR]: 0.62-2.08) ng/ml in Group 1, 1.87 (IQR: 1.27-2.97) in Group 2, and 1.53 (IQR: 1.18-2.44) in Group 3. CONCLUSION The present study suggests that there is no difference between the different hemostatic techniques used in laparoscopic cystectomy for the treatment of unilateral endometriomas.