Plasma trial: Pilot randomized clinical trial to determine safety and efficacy of plasma transfusions
BACKGROUND Plasma is frequently administered to patients with prolonged INR prior to invasive procedures. However, there is limited evidence evaluating efficacy and safety. STUDY DESIGN AND METHODS We performed a pilot trial in hospitalized patients with INR between 1.5 and 2.5 undergoing procedures conducted outside the operating room. We excluded patients undergoing procedures proximal to the central nervous system, platelet counts <40,000/μl, or congenital or acquired coagulation disorders unresponsive to plasma. We randomly allocated patients stratified by hospital and history of cirrhosis to receive plasma transfusion (10-15 cc/kg) or no transfusion. The primary outcome was change in hemoglobin concentration within 2 days of procedure. RESULTS We enrolled 57 patients, mean age 56.0, 34 (59.6%) with cirrhosis, and mean INR 1.92 (SD = 0.27). In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm (p < .01). The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure hemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm (p = .29). Adverse outcomes were uncommon. DISCUSSION We found no differences in change in hemoglobin concentration in those treated with plasma compared to no treatment. The change in INR was small and corrected to less than 1.5 in minority of patients. Large trials are required to establish if plasma is safe and efficacious.
Patients with cirrhosis (n= 57).
Plasma transfusion (n= 27).
No transfusion (n= 30).
In the intention to treat analysis, there were 10 of 27 (38.5%) participants in the plasma arm with a post procedure INR <1.5 and one of 30 (3.6%) in the no treatment arm. The mean INR after receiving plasma transfusion was -0.24 (SD 0.26) lower than baseline. The change from pre-procedure haemoglobin level to lowest level within 2 days was -0.6 (SD = 1.0) in the plasma transfusion arm and -0.4 (SD = 0.6) in the no transfusion arm. Adverse outcomes were uncommon.
Artificial Dermis and Autologous Platelet-Rich Plasma for Treatment of Refractory Wounds: A Clinical Study
The international journal of lower extremity wounds. 2021;:15347346211050710
Refractory wounds present a complex and serious clinical dilemma in plastic and reconstructive surgery. However, there are currently no standard guidelines for the treatment of refractory wounds. Artificial dermis (AD) has achieved some satisfactory results, but also has some limitations. Autologous platelet-rich plasma (PRP), as a cell-therapy material, was a valuable and safe treatment dressing for chronic non-healing wounds. This study aimed to evaluate the efficacies of artificial dermis (AD) with and without autologous platelet-rich plasma (PRP) in patients with refractory wounds. Sixteen patients with refractory wounds were randomly allocated to autologous PRP therapy combined with artificial dermis (PRP + AD [N = 8]) or an artificial dermis program only (AD [N = 8]). We compared the efficacies of the two methods in terms of times to wound healing, infection control, and AD vascularization, as well as hospitalization days and eventual clinical outcomes.13 patients achieved complete healing, including seven (87.5%) in the PRP + AD group and six (75.0%) in the AD group (P > .05). The times to wound healing, infection control, and AD vascularization, and hospitalization time after transfer were significantly shorter in the PRP + AD group compared with the AD group (P < .05). In conclusion, the combination of AD and PRP promoted refractory wound healing and shortened waiting times compared with simple dermal grafts.
Objective assessment of Platelet-Rich Plasma (PRP) potentiality in the treatment of Chronic leg Ulcer: RCT on 80 patients with Venous ulcer
Journal of cosmetic dermatology. 2021;20(10):3257-3263
BACKGROUND Chronic venous leg ulcer reduces the patients' activities and their overall quality of life. Platelet-rich plasma (PRP) was previously investigated as promising less invasive management for leg ulcers. THIS STUDY AIMS To re-assess the efficacy and safety of PRP in the management of chronic leg ulcers due to venous factors. PATIENTS/METHODS RCT enrolled 80 patients who clinically presented with chronic venous leg ulcers. Forty patients were allocated randomly for the treatment with autologous platelet-rich plasma (PRP). Intradermal and subdermal injection of PRP by 27guage syringe weekly, in all edges and in the granular floor of the ulcer for 4-6 sessions. Another 40 patients managed by conventional treatment by compression and dressing for the same period were allocated as Group B. Objective assessment achieved by the percentage of reduction of the size of the ulcer area, rate of healing, incidence of recurrence, and if side effects have been reported. RESULTS PRP therapy showed better results and high p value significance when compared to conventional therapy. CONCLUSION This study shows that PRP is effective and significant in promoting the wound healing process in chronic leg venous ulcers. PRP is simple, safe, and has a short learning curve technique.
Comparison of Hematocrit Change in Preterm Neonates with Birth Weight Based Versus Formula Based Packed Red Blood Cell Transfusion: A Randomized Control Trial
Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion. 2021;:1-7
Conventionally the packed red blood cell (PRBC) transfusion volume given to neonates is 10 ml/kg to 20 ml/kg. The weight-based formulae underestimate the volume of PRBC required to achieve a target hematocrit (Hct) in preterm neonates. The study was done to compare the rise in Hct after transfusing PRBC volume calculated either based on body weight or using formula considering Hct of blood bag and Hct of preterm neonates. This prospective study included a total of 68 preterm neonates requiring transfusion for the first time having ≤ 34 weeks of gestational age. Neonates were randomized using block randomization, to receive 15 ml/kg of PRBC transfusion (group A) or transfusion based on the formula (group B). The primary outcome of interest was post-transfusion rise in hematocrit. The secondary outcome was the effect of transfusion on neonatal morbidities in terms of retinopathy of prematurity, bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, and death. Baseline variables (birth weight, gestation age, APGAR score and score of neonatal acute physiology) pre-transfusion hemodynamics and hematocrit of the bag were comparable in both groups. The mean volume of PRBC in group A was 18.8 ± 4.9 ml, whereas in group B it was 29.6 ± 7.3 ml, p = 0.0001. Group B transfusions had a statistically significant change in 24 h post-transfusion hematocrit. Secondary outcomes were comparable in two groups. Post transfusion rise in Hct of the patient in group B was significant as compared to group A. The study needed huge sample size to establish a difference in the number of re-transfusions required across two groups. The trial was registered under the clinical trial registry of India (CTRI/2018/01/011,063). SUPPLEMENTARY INFORMATION The online version contains supplementary material available at 10.1007/s12288-021-01420-1.
Effect of Platelet-Rich Plasma Injection vs Sham Injection on Tendon Dysfunction in Patients With Chronic Midportion Achilles Tendinopathy: A Randomized Clinical Trial
IMPORTANCE Platelet-rich plasma injections are used as a treatment for chronic midportion Achilles tendinopathy, but evidence for this treatment is limited. OBJECTIVE In adults with midportion Achilles tendinopathy, to assess the effects of a single platelet-rich plasma injection, compared with sham injection, on the outcome of the Victorian Institute of Sport Assessment-Achilles (VISA-A) score (a single composite measure of Achilles tendinopathy severity). DESIGN, SETTING, AND PARTICIPANTS A participant-blinded, multicenter randomized clinical trial that included 240 people from 24 sites assigned to either a platelet-rich plasma injection or a sham injection between April 2016 and February 2020. Final follow-up was July 2020. Participants were older than 18 years with midportion Achilles tendon pain for more than 3 months as confirmed by ultrasound, magnetic resonance imaging, or both. INTERVENTIONS A single intratendinous platelet-rich plasma injection (n = 121) or a single sham injection (insertion of a subcutaneous dry needle not entering the tendon) (n = 119). MAIN OUTCOMES AND MEASURES The primary outcome was the VISA-A score, measured 6 months after treatment allocation. The VISA-A score contains 8 questions that cover 3 domains of pain, function, and activity, analyzed as a composite score (range, 0 [worst symptoms] to 100 [no symptoms]; minimal clinically important difference in score, 12 points). The primary analysis was adjusted for laterality, age, sex, and baseline VISA-A score. RESULTS Among 240 patients assigned to a platelet-rich plasma or sham injection (mean age, 52 years; 138 [58%] women), 221 (92%) completed the trial. At 6-month follow-up, mean VISA-A score values in the plasma-rich plasma group vs the sham injection group were 54.4 vs 53.4 (adjusted mean difference, -2.7 [95% CI, -8.8 to 3.3]). The most common adverse events compared between patients in the platelet-rich plasma group vs the sham group were injection site discomfort (97 vs 73 patients), swelling (56 vs 52 patients) and bruising (48 vs 49 patients). CONCLUSIONS AND RELEVANCE Among patients with chronic midportion Achilles tendinopathy, treatment with a single injection of intratendinous platelet-rich plasma, compared with insertion of a subcutaneous dry needle, did not reduce Achilles tendon dysfunction at 6 months. These findings do not support the use of this treatment for chronic midportion Achilles tendinopathy. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN13254422.
Advanced platelet-rich fibrin plus and osseous bone graft for socket preservation and ridge augmentation - A randomized control clinical trial
Journal of oral biology and craniofacial research. 2021;11(2):225-233
OBJECTIVE To compare the clinical and radiographic effectiveness of A PRF Plus as an adjuctive material to osseous bone graft in socket preservation and ridge augmentation. METHODS Twenty patients with need to preserve extraction socket in non-molar sites planning for further prosthetic rehabilitation were divided into two groups. Test Group (Group A) was treated with A PRF Plus membrane and Sybograf plus ™ (70% HA and 30 %β TCP) bone graft. The Control Group (Group B) was treated with Sybograf plus ™ (70% HA and 30% βTCP) bone graft. Both groups had same socket preservation surgical technique. RESULTS Both Group A and Group B showed significant improvement in clinical and radiographic parameters. Mean socket length, Vertical Resorption reduction in Group A was 1.48 whereas in Group B was 1.67 which is statistically significant. (p ≤ 0.05). Changes in Horizontal width reduction at 1,3, and 5 mm depth of the socket for both groups were not statistically significant. The Gain in socket fill for Group A and B 6 months postoperatively was 1185.30HU ± 473.21 and 966.60 HU ± 273.27 respectively. But intergroup comparison was not statistically significant. (p = 0.17). There were no significant statistical differences in postoperative pain in Group A and Group B as subjects experienced moderate amount of pain. The assessment of post-operative swelling showed that only 30% subjects in Group A reported with swelling. Whereas 80% subjects in Group B complained of post-operative swelling. CONCLUSION The results of the present study proved utilisation of A PRF Plus as a promising adjunct to conventional regenerative therapy for socket preservation.
Expression of Vascular Endothelial Growth Factor Using Platelet Rich Fibrin (PRF) and Nanohydroxyapatite (nano-HA) in Treatment of Periodontal Intra-Bony Defects - A Randomized Controlled Trial
Saudi journal of biological sciences. 2021;28(1):870-878
The study aims to assess the concentration of vascular endothelial growth factors (VEGF) with platelet rich fibrin (PRF) biomaterial, while using it separately or in combination with nanohydroxyapatite (nano-HA) for treating intra-bony defects (IBDs) using radiographic evaluation (DBS-Win software). Sixty patients with IBD (one site/patient) and chronic periodontitis were recruited randomly to test either autologous PRF platelet concentrate, nano-HA bone graft, a combination of PRF platelet concentrate and nano-HA, or alone conventional open flap debridement (OFD). Recordings of clinical parameters including probing depth (PD), gingival index (GI), and clinical attachment level (CAL) were obtained at baseline and 6 months, post-operatively. One-way analysis of variance (ANOVA) was used to compare four groups; whereas, multiple comparisons were done through Tukey's post hoc test. The results showed that CAL at baseline changed from 6.67 ± 1.23 to 4.5 ± 1.42 in group I, 6.6 ± 2.51 to 4.9 ± 1.48 in group II, 5.2 ± 2.17 to 3.1 ± 1.27 in group III, and 4.7 ± 2.22 to 3.7 ± 2.35 in group IV after 6 months. The most significant increase in bone density and fill was observed for IBD depth in group III that was recorded as 62.82 ± 24.6 and 2.31 ± 0.75 mm, respectively. VEGF concentrations were significantly increased at 3, 7, and 14 days in all groups. The use of PRF with nano-HA was successful regenerative periodontal therapy to manage periodontal IBDs, unlike using PRF alone. Increase in VEGF concentrations in all group confirmed its role in angiogenesis and osteogenesis in the early stages of bone defect healing.
Clinical and Radiographic Analysis of Novabone Putty with Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects: A Randomized Control Trial
Contemporary clinical dentistry. 2021;12(2):150-156
BACKGROUND Periodontal regeneration remains one of the crucial issues in the field of periodontology. Periodontal intrabony defects could be treated by surgical intervention through various alloplastic bone graft substitutes. The Food and Drug Administration approved, Novabone putty is one of the recently marketed bone graft substitutes, which has been used in the present study. This study also incorporates the placement of platelet-rich fibrin (PRF) in combination with Novabone putty. MATERIALS AND METHODS Twenty patients were included in the study and were allocated to either Group A or Group B through randomization. Group A included the placement of Novabone putty in the periodontal intrabony defects, whereas Group B included the placement of Novabone putty along with PRF. Statistical analysis of plaque index, gingival index, probing pocket depth, relative attachment level, and intraoral periapical radiographs was performed. RESULTS Statistical more significant difference (P < 0.05) in probing pocket depth, and relative attachment level was observed in Group B (Novabone putty and PRF) in comparison to Group A (Novabone putty). CONCLUSION Evaluation of efficacy of Novabone putty along with PRF produced more favorable results in relative attachment level gain and more reduction in probing pocket depth when compared to Novabone putty alone.
A comparative evaluation of Advanced Platelet-Rich Fibrin (A-PRF) and Platelet-Rich Fibrin (PRF) as a Scaffold in Regenerative Endodontic Treatment of Traumatized Immature Non-vital permanent anterior teeth: A Prospective clinical study
Journal of clinical and experimental dentistry. 2021;13(5):e463-e472
BACKGROUND Regenerative endodontic treatment (RET) is a promising treatment alternative for traumatized immature non-vital teeth. Advanced platelet-rich fibrin (A-PRF) contains significantly more growth factors than Platelet-rich fibrin (PRF) and has not been evaluated as a scaffold in RET. The aim of the present study was to evaluate and compare A-PRF and PRF as scaffolds in the RET concerning periapical healing, and root development of traumatized immature non-vital teeth. MATERIAL AND METHODS In the present study, RET was performed on 30 traumatized immature non-vital maxillary incisors in 28 patients aged between 8-27 years. Minimal mechanical debridement and irrigation with 1.5% sodium hypochlorite and 17% ethylenediaminetetraacetic acid was performed. Canals were disinfected using modified triple antibiotic paste consisting of ciprofloxacin, metronidazole and cefaclor. Based on the type of scaffold, teeth were randomly assigned into A-PRF (n=15) and PRF groups (n=15). Periapical healing, apical response and quantitative root dimensions (length and thickness) were analyzed radiographically after 12 months follow-up. RESULTS Nineteen patients with 21 teeth (A-PRF n=11, PRF n=10) completed the follow-up and 9 patients were excluded. Clinically, patients in both the groups were asymptomatic. The survival rates for A-PRF and PRF were 78.5% and 77.5%, respectively. No statistically significant differences were detected between A-PRF and PRF regarding periapical healing and type of apical response (p& 0.05). The difference in the pre-operative and follow-up root thickness and root length in both A-PRF and PRF groups were statistically significant (p< 0.05). CONCLUSIONS Based on short-term results of 13 months, both A-PRF and PRF can be used as scaffold in regenerative endodontic treatment of traumatized immature non-vital teeth. A-PRF could be recommended in such cases since it yielded more root dentin thickness which is crucial for reinforcing immature teeth. Key words:Regenerative endodontic treatment, dental trauma, Non-vital teeth, immature teeth, platelet-rich fibrin, advanced platelet-rich fibrin.
Assessment of recurrent anal fistulas treatment with platelet-rich plasma
Arquivos de gastroenterologia. 2021
BACKGROUND Surgical treatment of recurrent anal fistulas can lead to numerous complications, including fecal incontinence. Therefore, sphincter preserving techniques are gaining more popularity. OBJECTIVE The aim of the study was to assess effectiveness of platelet-rich plasma (PRP) therapy in the patients with recurrent cryptoglandular anal fistulas. METHODS A cohort of 18 patients with anal fistulas was enrolled into a preliminary and prospective trial. They were divided into two groups consisting of eight and ten patients respectively. PRP was injected locally in all patients, however in the group II it was applied after 7 days drainage of fistulas with polyurethane foam or negative pressure wound therapy. On average, three doses of PRP were administered, but with the opportunity to double the number of applications if it was clinically justified. The patients were evaluated in an out-patient department after fortnight and then in 1, 6, and 12 months following the last PRP application. RESULTS Anal fistulas were closed in 4 (50%) patients from the group I and in 7 (70%) patients form the group II. Although, the difference between both groups was not statistically significant, PRP therapy should be preceded with fistulous tract drainage in all patients. Summarizing, that successful result was achieved in 11 (60%) patients from the entire group of 18 participants. CONCLUSION The rate of recurrent cryptoglandular anal fistulas closure reaching 60%, after topical treatment with PRP, exceeds the results of other sphincter-saving methods of treatment. Therefore, it might become a novel method of anal fistulas therapy.