Hemostatic Agent May Improve Perioperative Outcomes in Partial Nephrectomy: A Systematic Review and Meta-Analysis
Urologia internationalis. 2021;:1-8
BACKGROUND Hemostatic agents (HAs) are used to achieve hemostasis and prevent postoperative complications in multiple surgeries, but the role of HAs is ambiguous during partial nephrectomy (PN), so this study aimed to assess the role of HAs in PN. METHODS PubMed, Embase, CENTRAL and ClinicalTrials.gov were searched for randomized controlled trials and cohort studies regarding the comparison of HA use alone and standard suturing during PN on January 17, 2020. RevMan 5.3 was used to conduct meta-analysis. Sensitivity analyses and subgroup analyses were performed based on surgical procedures and HA types. RESULTS Six studies involving 1,066 patients were included. The quality of studies was moderate to high. There were significant reductions in warm ischemia time (mean difference [MD] = -6.30 min, 95% confidence interval [CI] -7.70 to -4.90, p < 0.00001), operative time (MD = -19.81 min, 95% CI -27.54 to -12.08, p < 0.00001), and estimated blood loss (MD = -108.62 mL, 95% CI -177.27 to -39.9, p = 0.002) in the HA group, and HA use alone did not increase postoperative complications. The results were similar in the subgroup analyses and sensitivity analyses. CONCLUSION HA may be an effective and safe surgical material in PN, which can improve postoperative outcomes. High-quality and randomly designed studies are needed to validate the applicability.
Fractional Carbon Dioxide Laser or Erbium:Yttrium-Aluminum-Garnet Laser Assisted by Topical Application/Intradermal Injection of Platelet-Rich Plasma for Postacne Scars
Plastic and reconstructive surgery. 2021;148(6):915e-927e
BACKGROUND Fractional carbon dioxide or erbium:yttrium-aluminum-garnet (YAG) laser combined with platelet-rich plasma has been used for postacne scars. Nevertheless, there is limited evidence on its use because of the small size of relevant studies. This study aims to evaluate the efficacy of platelet-rich plasma-assisted laser for postacne scars. METHODS Randomized controlled trials comparing carbon dioxide or erbium:YAG laser combined with platelet-rich plasma to laser alone were searched for using the PubMed, Embase, Web of Science, Cochrane Library, and Google Scholar databases. RESULTS In total, 13 studies involving 672 cases were included. The overall degree of clinical improvement favored platelet-rich plasma combined with carbon dioxide laser (mean difference, 0.55; 95 percent CI, 0.40 to 0.70) or erbium:YAG laser (mean difference, 0.63; 95 percent CI, 0.31 to 0.96). Notably, the use of carbon dioxide laser combined with platelet-rich plasma was more effective in both greater than 50 percent improvement of acne scars (OR, 1.63; 95 percent CI, 1.10 to 2.42) and greater than 75 percent improvement of acne scars (OR, 2.78; 95 percent CI, 1.75 to 4.42), compared with laser alone. Erbium:YAG laser combined with platelet-rich plasma was more effective in greater than 75 percent improvement of acne scars compared with laser alone (OR, 3.45; 95 percent CI, 1.31 to 9.05). Moreover, patient satisfaction was significantly higher with platelet-rich plasma combined with carbon dioxide laser (OR, 2.98; 95 percent CI, 1.72 to 5.16) or erbium:YAG laser (OR, 2.88; 95 percent CI, 1.33 to 6.21) compared to laser alone. CONCLUSION This meta-analysis provides reliable evidence that fractional carbon dioxide or erbium:YAG laser combined with platelet-rich plasma is an effective and safe combination therapy for postacne scars. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.
Red cell transfusion in outpatients with myelodysplastic syndromes: a feasibility and exploratory randomised trial
British journal of haematology. 2020
Optimal red cell transfusion support in myelodysplastic syndromes (MDS) has not been tested and established. The aim of this study was to demonstrate feasibility of recruitment and follow-up in an outpatient setting with an exploratory assessment of quality of life (QoL) outcomes (EORTC QLQ-C30 and EQ-5D-5L). We randomised MDS patients to standardised transfusion algorithms comparing current restrictive transfusion thresholds (80 g/l, to maintain haemoglobin 85-100 g/l) with liberal thresholds (105 g/l, maintaining 110-125 g/l). The primary outcomes were measures of compliance to transfusion thresholds. Altogether 38 patients were randomised (n = 20 restrictive; n = 18 liberal) from 12 participating sites in UK, Australia and New Zealand. The compliance proportion for the intention-to-treat population was 86% (95% confidence interval 75-94%) and 99% (95-100%) for restrictive and liberal arms respectively. Mean pre-transfusion haemoglobin concentrations for restrictive and liberal arms were 80 g/l (SD6) and 97 g/l (SD7). The total number of red cell units transfused on study was 82 in the restrictive and 192 in the liberal arm. In an exploratory analysis, the five main QoL domains were improved for participants in the liberal compared to restrictive arm. Our findings support the feasibility and need for a definitive trial to evaluate the effect of different red cell transfusion thresholds on patient-centred outcomes.
Patients with myelodysplastic syndrome, (n=38).
Restrictive transfusion threshold (80 g/l, to maintain haemoglobin 85-100 g/l), (n=20).
Liberal transfusion threshold (105 g/l, to maintain haemoglobin 110-125 g/l), (n=18).
The compliance proportion for the intention-to-treat population was 86% and 99% for restrictive and liberal arms respectively. Mean pre-transfusion haemoglobin concentrations for restrictive and liberal arms were 80 g/l (SD6) and 97 g/l (SD7). The total number of red cell units transfused on study was 82 in the restrictive and 192 in the liberal arm. In an exploratory analysis, the five main QoL domains were improved for participants in the liberal compared to restrictive arm.
Perioperative oral eltrombopag versus intravenous immunoglobulin in patients with immune thrombocytopenia: a non-inferiority, multicentre, randomised trial
The Lancet. Haematology. 2020;7(9):e640-e648
BACKGROUND Patients with immune thrombocytopenia are at risk of bleeding during surgery, and intravenous immunoglobulin is commonly used to increase the platelet count. We aimed to establish whether perioperative eltrombopag was non-inferior to intravenous immunoglobulin. METHODS We did a randomised, open-label trial in eight academic hospitals in Canada. Patients were aged at least 18 years, with primary or secondary immune thrombocytopenia and platelet counts less than 100 × 10(9) cells per L before major surgery or less than 50 × 10(9) cells per L before minor surgery. Previous intravenous immunoglobulin within 2 weeks or thrombopoietin receptor agonists within 4 weeks before randomisation were not permitted. Patients were randomly assigned to receive oral daily eltrombopag 50 mg from 21 days preoperatively to postoperative day 7 or intravenous immunoglobulin 1 g/kg or 2 g/kg 7 days before surgery. Eltrombopag dose adjustments were allowed weekly based on platelet counts. The randomisation sequence was generated by a computerised random number generator, concealed and stratified by centre and surgery type (major or minor). The central study statistician was masked to treatment allocation. The primary outcome was achievement of perioperative platelet count targets (90 × 10(9) cells per L before major surgery or 45 × 10(9) cells per L before minor surgery) without rescue treatment. We did intention-to-treat and per-protocol analyses using an absolute non-inferiority margin of -10%. This trial is registered with ClinicalTrials.gov, NCT01621204. FINDINGS Between June 5, 2013, and March 7, 2019, 92 patients with immune thrombocytopenia were screened, of whom 74 (80%) were randomly assigned: 38 to eltrombopag and 36 to intravenous immunoglobulin. Median follow-up was 50 days (IQR 49-55). By intention-to-treat analysis, perioperative platelet targets were achieved for 30 (79%) of 38 patients assigned to eltrombopag and 22 (61%) of 36 patients assigned to intravenous immunoglobulin (absolute risk difference 17·8%, one-sided lower limit of the 95% CI 0·4%; p(non-inferiority)=0·005). In the per-protocol analysis, perioperative platelet targets were achieved for 29 (78%) of 37 patients in the eltrombopag group and 20 (63%) of 32 in the intravenous immunoglobulin group (absolute risk difference 15·9%, one-sided lower limit of the 95% CI -2·1%; p(non-inferiority)=0·009). Two serious adverse events occurred in the eltrombopag group: one treatment-related pulmonary embolism and one vertigo. Five serious adverse events occurred in the intravenous immunoglobulin group (atrial fibrillation, pancreatitis, vulvar pain, chest tube malfunction and conversion to open splenectomy); all were related to complications of surgery. No treatment-related deaths occurred. INTERPRETATION Eltrombopag is an effective alternative to intravenous immunoglobulin for perioperative treatment of immune thrombocytopenia. However, treatment with eltrombopag might increase risk of thrombosis. The decision to choose one treatment over the other will depend on patient preference, resource limitations, cost, and individual risk profiles. FUNDING GlaxoSmithKline and Novartis.
Platelet-rich fibrin and concentrated growth factors as novel platelet concentrates for chronic hard-to-heal skin ulcers: A systematic review and meta-analysis of randomized controlled trials
J Dermatolog Treat. 2020;:1-28
Background: This study aimed to determine superior outcomes of platelet-rich fibrin and concentrated growth factors dressings in chronic hard-to-heal skin ulcers.Methods: A search in PubMed, EMBASE, Cochrane Library and CINAHL(EBSCO) was performed for randomized controlled trials comparing platelet-rich fibrin or concentrated growth factors dressings to standard wound care in chronic hard-to-heal skin ulcers. Primary outcome was the number of ulcers completely healed. Secondary outcomes were percentage of ulcers area reduction and complications. Dichotomous and continuous results were pooled in risk difference and mean difference respectively, with a 95% confidence interval (CI).Results: Eight studies with 578 patients were included. The number of ulcers completely healed in platelet-rich fibrin was significantly higher than in control group, during the fourth week of follow-up (risk difference, 0.48; 95% CI, 0.31 - 0.66; p < 0.00001) and at the end of follow-up (risk difference, 0.17; 95% CI, 0.08 - 0.26; p = 0.0003). The pooled result between concentrated growth factors and control group was inconclusive due to two few studies included.Conclusions: Platelet-rich fibrin is safe and promising to promote healing of chronic hard-to-heal skin ulcers versus standard wound care. Further studies are warranted to evaluate the roles of concentrated growth factors.
The application of platelet-rich plasma for skin graft enrichment: A meta-analysis
Int Wound J. 2020
Existing evidence demonstrated that the role of platelet-rich plasma (PRP) in skin graft enrichment is uncertain. The aim of this study was to evaluate the efficacy and safety of PRP for skin graft. PubMed, EMBASE, Web of Science, and Cochrane Library databases were searched for randomised controlled trials that compared outcomes of skin graft treated with PRP versus those treated with blank controls. The outcomes mainly included the rate of skin graft take, number of skin graft loss and haematoma formation, and complications. There were 11 studies involving a total of 910 cases of skin grafts. Compared with the control group, PRP group had a significantly higher rate of skin graft take (mean difference = 5.47%; 95% confidence interval [CI], 2.80%-8.14%; P < .0001), fewer number of skin graft loss (risk ratio [RR] = 0.26; 95% CI, 0.13-0.55; P = .0004) and fewer cases of haematoma formation (RR = 0.24; 95% CI, 0.11-0.54; P = .0006). There was no significant difference in the incidence of complications between two groups. This meta-analysis summarises current evidence and indicates that PRP is a safe and effective adjuvant for skin graft enrichment.
Comparison of hemocoagulase atrox versus tranexamic acid used in primary total knee arthroplasty: A randomized controlled trial
Thrombosis research. 2020;188:39-43
BACKGROUND Total knee arthroplasty (TKA) has been considered as an effective choice for end-stage osteoarthritis or rheumatic arthritis. Tranexamic acid (TXA) has been widely used to prevent excessive blood loss perioperatively. Similarly, hemocoagulase atrox can significantly diminish blood loss and transfusion requirements in surgeries, however, it was rarely used in TKA. The purpose of this study is to identify whether hemocoagulase atrox is equal to TXA in reducing blood loss and transfusion rates following TKA, and compare clinical outcomes and complications between the two groups. METHODS 74 patients were randomized to receive TXA (1.5 g intra-articular combined with 1.5 g intravenous), or hemocoagulase atrox (1 U intra-articular combined with 1 U intravenous). The primary outcome was total blood loss. The secondary outcomes included reduction of hemoglobin concentration, clinical outcomes, blood coagulation values, thromboembolic complications, and transfusion rates. RESULTS The mean total blood loss was 431.7 mL in the TXA group compared with 644.6 mL in the hemocoagulase atrox group, with statistical significance (P < 0.05). There were significant differences in reduction of hemoglobin level (P < 0.05). The rate of deep vein thrombosis (DVT) in patients given TXA was higher than those given hemocoagulase atrox, however, there were no significant differences. No transfusions were required in either group, and no significant differences were found in the length of hospital stay and clinical outcomes. CONCLUSIONS Although the blood loss was significantly greater in the hemocoagulase atrox group, no transfusions were required and no significant differences were observed for any other outcomes measured. Meanwhile, the rate of DVT in the hemocoagulase atrox group tends to be lower than those in TXA group. We concluded that hemocoagulase atrox was not superior to TXA in reducing perioperative blood loss. Further studies are warranted to evaluate if hemocoagulase atrox use could improve perioperative blood loss in patients with high thrombotic risk undergoing TKA.
Peri-Operative Eltrombopag or Immune Globulin for Patients with Immune Thrombocytopaenia (The Bridging ITP Trial): Methods and Rationale
Thrombosis and haemostasis. 2019
BACKGROUND The Bridging ITP Trial is an open-label randomized trial designed to compare the oral thrombopoietin receptor agonist eltrombopag and intravenous immune globulin (IVIG) for patients with immune thrombocytopaenia (ITP) who require an increase in platelet count before elective surgery. Here, we report the study methods and rationale. METHODS We designed a multi-centre, non-inferiority randomized trial comparing daily oral eltrombopag starting 3 weeks pre-operatively, and IVIG administered 1 week pre-operatively for patients with ITP requiring a platelet count increase prior to surgery. Starting dose of eltrombopag is 50 mg daily with a weekly pre-operative dose titration schedule, and treatment is continued for 1 week after surgical haemostasis is achieved. IVIG is administered at a dose of 1 to 2 g/kg 1 week pre-operatively with the allowance for a second dose within 1 week after surgical haemostasis. The objective of the study is to demonstrate non-inferiority of eltrombopag for the primary endpoint of achieving the pre-operative platelet count threshold (50 x 10(9)/L for minor surgery; or 100 x 10(9)/L for major surgery) and sustaining platelet count levels above the threshold for 1 week after surgical haemostasis is achieved, without the use of rescue treatment. Secondary endpoints include thrombosis, bleeding and patient satisfaction. CONCLUSION The Bridging ITP Trial will evaluate the efficacy and safety of eltrombopag as an alternative to IVIG in the peri-operative setting for patients with ITP. The protocol was designed to provide a management strategy that can be applied in clinical practice. CLINICALTRIALS. GOV IDENTIFIER NCT01621204.
[Prospective clinical study on extracorporeal shock wave therapy combined with platelet-rich plasma injection for knee osteoarthritis]
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery. 2019;33(12):1527-1531
Objective: To investigate the effectiveness of extracorporeal shock wave therapy combined with platelet-rich plasma (PRP) injection in treatment of knee osteoarthritis (KOA) by prospective clinical study. Methods: Between June 2015 and June 2018, 180 patients with KOA met the inclusion criteria were included in study and randomly allocated to group A (n=60), group B (n=60), and group C (n=60). The patients were treated with autologous PRP intra-articular injection in group A, extracorporeal shock wave therapy in group B, and extracorporeal shock wave therapy combined with autologous PRP intra-articular injection in group C, once a week and 5 times a duration of treatment. There was no significant difference in age, gender, disease duration, side of KOA, and Kellgren-Lawrence grading between groups (P>0.05). The pain and function of knee joint were assessed by visual analogue scale (VAS) score, Lequesne Index score, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, and knee joint activity before treatment and at 1, 3, and 5 weeks after the first treatment. Results: There were significant differences in VAS score, Lequesne Index score, WOMAC score, and knee joint activity between pre- and post-treatment in all groups (P<0.05). VAS score, Lequesne Index score, and WOMAC score gradually decreased with the prolongation of treatment time (P<0.05); but there was no significant difference in knee joint activity between different time points (P>0.05). There was no significant difference in VAS score, Lequesne Index score, WOMAC score, and knee joint activity between groups before treatment (P>0.05); the scores of group C were superior to groups A and B (P< 0.05) at different time points after treatment; while the knee joint activities of 3 groups were similar (P>0.05). Conclusion: The extracorporeal shock wave therapy combined with PRP injection can relieve the pain synergistically for KOA.
Can furosemide prevent transfusion-associated circulatory overload? Results of a pilot, double-blind, randomized controlled trial
BACKGROUND Transfusion-associated circulatory overload (TACO) is a leading cause of transfusion-attributable morbidity. It is unclear whether diuretics are safe and effective in preventing this reaction. MATERIALS AND METHODS In a pilot controlled feasibility trial, inpatients 65 years or older ordered a single unit of red blood cells were randomized to pre-transfusion furosemide 20 mg or placebo intravenously. Primary outcome was the ability to enroll 80 patients within a 2-month time period. Secondary feasibility outcomes included proportion of RBC transfusions meeting eligibility criteria, proportion of eligible patients enrolled, and compliance to study protocol. Clinical outcomes included the incidence of TACO and associated complications. RESULTS Nine months of enrollment were required for 80 patients to complete the study, due primarily to fewer transfusions than expected meeting eligibility criteria and lower than anticipated consent rates. Protocol compliance was below target due to missing chart documentation of patient fluid balance, and transfusion infusion time. Blinding was maintained throughout the study and treatment arms were well-balanced. A single case of TACO occurred in each arm, for an overall incidence of 2.5%. No differences in peri-transfusion vital signs, B-natriuretic peptide, or signs of furosemide toxicity were observed. CONCLUSION The study protocol was not feasible as designed, primarily due to challenges in patient enrollment. Modifications to trial design to improve feasibility in future studies have been identified.