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The wound healing effect of local leukocyte platelet-rich plasma after total hip arthroplasty: A randomized controlled trial
Capion SC, Jørgensen HBL, Ågren MS, Daugaard H, Ribel-Madsen S, Marando D, Johansson PI, Salado J, Halschou-Jensen PM, Borgwardt A, et al
Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society. 2021
Abstract
Rapid wound closure is important after arthroplasty procedures to prevent postoperative complications. Platelets are rich in growth factors and leukocytes contribute to innate immunity. We hypothesized that topical leukocyte platelet-rich plasma (L-PRP) derived from the blood of patients would be beneficial to wound healing. In this randomized controlled trial, patients subjected to elective total hip arthroplasty (THA) were assigned by concealed allocation either L-PRP application onto the sutured fascia or no application (control) after the THA intervention. In addition, all patients received 1.5 g protein/kg, 5 g L-arginine, 500 mg vitamin C and 44 mg zinc daily over the 4-week postoperative period to obtain optimal nutrition. The primary endpoint was complete healing of the skin incision. The secondary endpoints were blood transfusions, length of hospital stay, pain and wound infections. Sixteen patients in the L-PRP group and 17 patients in the control group completed the trial. L-PRP treatment accelerated complete wound healing after 3 weeks (seven in the L-PRP group vs. zero in the control group, p = 0.003) and after 4 weeks (12 in the L-PRP group vs. six in the control group, p = 0.037). No postoperative superficial wound infections occurred within 4 weeks, and there were no significant differences in the other secondary outcomes. L-PRP generated in 10 sex-matched healthy volunteers revealed increased concentrations of platelets (5.8-fold) and leukocytes (2.3-fold) compared with those in whole blood. Furthermore, the concentration of keratinocyte mitogen epidermal growth factor in L-PRP (380 ± 130 pg/ml, mean ± SD) was higher (p < 0.001) than that in serum (130 ± 26 pg/ml). In conclusion, a single intraoperative local application of L-PRP promoted wound healing after THA, possibly mediated by EGF receptor agonists.
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The effect of intraoperative and 6-h postoperative intravenous administration of low-dose prostacyclin on the endothelium, hemostasis, and hemodynamics in patients undergoing a pancreaticoduodenoctemy: a randomized-controlled pilot study
Johansson PI, Mortensen CR, Nielsen T, Tollund C, Stensballe J, Hansen CP, Frederiksen HJ, Ostrowski SR
European Journal of Gastroenterology & Hepatology. 2016;29((4):):400-406
Abstract
BACKGROUND Capillary leakage, secondary to endothelial breakdown, is common in patients undergoing major surgical procedures with extensive tissue injury and this is associated with increased morbidity and mortality. Prostacyclin has been ascribed cytoprotective properties together with its vasodilatory and antiplatelet effects. The present pilot study investigated the safety and endothelial protective effects of low-dose prostacyclin infusion. PATIENTS AND METHODS A randomized placebo-controlled pilot study evaluating the effect of prostacyclin (iloprost) infusion (1.0 ng/kg/min) versus placebo (saline infusion) intraoperatively and 6 h postoperatively in patients undergoing a pancreaticoduodenoctemy was carried out. Hemodynamics were evaluated by Nexfin, hemostasis was evaluated by thrombelastography, and transfusion requirements were registered. Endothelial damage was evaluated by circulating sE-selectin, soluble thrombomodulin, and nucleosomes. RESULTS Comparable baseline demography and surgical time were found. Hemodynamics were comparable between groups. The placebo group received more red blood cells, median 115 ml [interquartile range (IQR): 0-296 ml] versus 0 ml (IQR: 0-0 ml), P=0.027, at the postoperative ward and after 6 h. Thrombelastography maximum clot firmness decreased intraoperatively only in the placebo group (P=0.034)). Soluble thrombomodulin increased more in the placebo group postoperatively [1.63 ng/ml (IQR: 0.65-2.55 ng/ml) versus 0.40 ng/ml (IQR: 0.21-0.63 ng/ml), P=0.027] and 6 h postoperatively [1.83 (1.1-2.36) versus 0.67 (0.42-0.91), P=0.027]. Nucleosomes increased intraoperatively and postoperatively only in the placebo group; thus, the overall level of nucleosomes was higher in the placebo group (P=0.019). CONCLUSION Intraoperative and postoperative low-dose prostacyclin infusion is safe and associated with reduced endothelial cell damage in patients undergoing a pancreaticoduodenoctemy compared with those receiving placebo.
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Impact of albumin on coagulation competence and hemorrhage during major surgery: a randomized controlled trial
Rasmussen KC, Hojskov M, Johansson PI, Kridina I, Kistorp T, Salling L, Nielsen HB, Ruhnau B, Pedersen T, Secher NH
Medicine. 2016;95((9)):e2720.
Abstract
For patients exposed to a massive blood loss during surgery, maintained coagulation competence is important. It is less obvious whether coagulation competence influences bleeding during elective surgery where patients are exposed to infusion of a crystalloid or a colloid.This randomized controlled trial evaluates whether administration of 5% human albumin (HA) or lactated Ringer solution (LR) affects coagulation competence and in turn blood loss during cystectomy due to bladder cancer.Forty patients undergoing radical cystectomy were included to receive either 5% HA (n = 20) or LR (n = 20). Nineteen patients were analyzed in the HA group and 20 patients in the lactated Ringer group.Blinded determination of the blood loss was similar in the 2 groups of patients: 1658 (800-3300) mL with the use of HA and 1472 (700-4330) mL in the lactated Ringer group (P = 0.45). Yet, by thrombelastography (TEG) evaluated coagulation competence, albumin affected clot growth (TEG-angle 69 +/- 5 vs 74 degrees +/- 3 degrees , P < 0.01) and strength (TEG-MA: 59 +/- 6 vs 67 +/- 6 mm, P < 0.001) more than LR. Furthermore, by multivariate linear regression analyses reduced TEG-MA was independently associated with the blood loss (P = 0.042) while administration of albumin was related to the changes in TEG-MA (P = 0.029), aPPT (P < 0.022), and INR (P < 0.033).This randomized controlled trial demonstrates that administration of HA does not affect the blood loss as compared to infusion of LR. Also the use of HA did not affect the need for blood transfusion, the incidence of postoperative complications, or the hospital in-stay. Yet, albumin decreases coagulation competence during major surgery and the blood loss is related to TEG-MA rather than to plasma coagulation variables.
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A randomized trial of the effect of low dose epinephrine infusion in addition to tranexamic acid on blood loss during total hip arthroplasty
Jans O, Grevstad U, Mandoe H, Kehlet H, Johansson PI
British Journal of Anaesthesia. 2016;116((3):):357-62
Abstract
BACKGROUND Total hip arthroplasty (THA) is associated with both intraoperative and postoperative blood loss resulting in anaemia and, in some patients, transfusion of red blood cells. Epinephrine enhances coagulation by several mechanisms. We evaluated the effect of intraoperative low dose infusion of epinephrine on intraoperative and early postoperative blood loss. METHODS After consent, 106 subjects undergoing THA under spinal anaesthesia were randomly assigned to receive an i.v. infusion of either epinephrine 0.05 microg kg-1 min-1 or placebo (saline 0.9%) during the entire surgical procedure. Intraoperative tranexamic acid (TXA) was administered to all subjects. The primary outcome was intraoperative blood loss directly measured by drains and weighing swabs. Secondary outcome was total blood loss at 24 h postoperatively calculated using the Gross formula. RESULTS Of 106 subjects randomized, 6 were excluded, leaving 100 subjects for analyses. Mean duration of surgery was 58 (21) min. Intraoperative blood loss was 343 (95% CI 300-386) ml in the epinephrine group compared with 385 (353-434) ml in the placebo group, P = 0.228. 24 h blood loss was 902 (800-1004) ml in the epinephrine group compared with 1080 (946-1220) ml in the placebo group, P = 0.038. CONCLUSION In subjects also receiving TXA, intraoperative low dose epinephrine infusion did not reduce intraoperative blood loss in THA but calculated 24 h blood loss was reduced by 180 ml compared with placebo. Further studies on low dose epinephrine in patients at high risk of significant bleeding are warranted. CLINICAL TRIAL REGISTRATION NCT 01708642.
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Intravenous iron isomaltoside 1000 (Monofer() ) reduces postoperative anaemia in preoperatively non-anaemic patients undergoing elective or subacute coronary artery bypass graft, valve replacement or a combination thereof: a randomized double-blind placebo-controlled clinical trial (the PROTECT trial)
Johansson PI, Rasmussen AS, Thomsen LL
Vox Sanguinis. 2015;109((3)):257-66.
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Abstract
BACKGROUND AND OBJECTIVES This trial explores whether intravenous iron isomaltoside 1000 (Monofer() ) results in a better regeneration of haemoglobin levels and prevents anaemia compared to placebo in preoperative non-anaemic patients undergoing cardiac surgery. STUDY DESIGN AND METHODS The trial is a prospective, double-blind, comparative, placebo-controlled trial of 60 non-anaemic patients undergoing cardiac surgery. The patients were randomized 1:1 to either 1000 mg intravenous iron isomaltoside 1000 administered perioperatively by infusion or placebo. RESULTS Mean preoperative haemoglobin in the active treatment group was 143 g/dl vs. 140 g/dl in the placebo group. At discharge 5 days after surgery, haemoglobin levels were reduced to 107 and 105 g/dl, respectively. One month after surgery, haemoglobin concentration had increased to an average of 126 g/dl vs. 118 g/dl (p = 0012) and significantly more patients were non-anaemic in the intravenous iron isomaltoside 1000-treated group compared to the placebo group (385% vs. 80%; p = 0019). There were no differences in side-effects between the groups. CONCLUSION A single perioperative 1000 mg dose of intravenous iron isomaltoside 1000 significantly increased the haemoglobin level and prevented anaemia 4 weeks after surgery, with a short-term safety profile similar to placebo. Future trials on potential clinical benefits of preoperative treatment with intravenous iron in non-anaemic patients are needed.Copyright © 2015 The Authors ISBT Science Series published by John Wiley & Sons Ltd on behalf of International Society of Blood Transfusion.
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Perioperative transfusion threshold and ambulation after hip revision surgery - a randomized trial
Nielsen K, Johansson PI, Dahl B, Wagner M, Frausing B, Borglum J, Jensen K, Sturup J, Hvolris J, Rasmussen LS
BMC Anesthesiology. 2014;14:89.
Abstract
BACKGROUND Transfusion with red blood cells (RBC) may be needed during hip revision surgery but the appropriate haemoglobin concentration (Hb) threshold for transfusion has not been well established. We hypothesized that a higher transfusion threshold would improve ambulation after hip revision surgery. METHODS The trial was registered at Clinicaltrials.gov ( NCT00906295). Sixty-six patients aged 18 years or older undergoing hip revision surgery were randomized to receive RBC at a Hb threshold of either 7.3 g/dL (restrictive group) or 8.9 g/dL (liberal group). Postoperative ambulation was assessed using Timed Up and Go-test (TUG) and ability to walk was also assessed daily by a physiotherapist blinded to the allocation. RESULTS Fifty-three patients were able to perform the TUG and included in the analysis. The TUG could be completed in a median of 36 sec vs. 30 sec in the restrictive group and the liberal group, respectively (P=0.02). The mean difference in TUG was 14.5 sec (95% CI 2.8-26.2 sec). No difference was found in the day patients could perform TUG or walk 10 meters. The Hb at the day of testing was 10.2 g/dL in the restrictive group and 9.9 g/dL in the liberal group. Only 26 patients received RBC. CONCLUSIONS A Hb transfusion threshold of 8.9 g/dL was associated with a statistically significantly faster TUG after hip revision surgery compared to a threshold of 7.3 g/dL but the clinical importance is questionable and the groups did not differ in Hb at the time of testing.
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Intraoperative transfusion threshold and tissue oxygenation: a randomised trial
Nielsen K, Dahl B, Johansson PI, Henneberg SW, Rasmussen LS
Transfusion Medicine. 2012;22((6):):418-25.
Abstract
BACKGROUND AND OBJECTIVES Transfusion with allogeneic red blood cells (RBCs) may be needed to maintain oxygen delivery during major surgery, but the appropriate haemoglobin (Hb) concentration threshold has not been well established. We hypothesised that a higher level of Hb would be associated with improved subcutaneous oxygen tension during major spinal surgery. MATERIALS AND METHODS Fifty patients aged 18 years or older scheduled for spinal fusion with instrumentation were included and randomised to receive RBCs at either a Hb concentration of 7.3 g dL (-1) (restrictive group) or a Hb concentration of 8.9 g dL (-1) (liberal group) (Registration no.: H-C-2009-072). Oxygen tension was measured with a polarographic electrode placed subcutaneously over the left deltoid muscle. The primary endpoint was subcutaneous oxygen tension at the time most patients were still undergoing surgery. RESULTS Forty-eight patients were included in the intention-to-treat analysis; 25 patients in the restrictive group and 23 patients in the liberal group. The median change in subcutaneous oxygen tension 60 min after surgical incision was -0.79 and -0.75 kPa in the restrictive and the liberal groups, respectively (P = 0.78). No significant difference was found in the lowest subcutaneous oxygen tension; -2.07 vs. -1.95 kPa in the restrictive and the liberal groups, respectively (P = 0.85). CONCLUSION A Hb concentration transfusion threshold of 8.9 g dL (-1) was not associated with a higher subcutaneous oxygen tension during major spinal surgery than a threshold of 7.3 g dL (-1), but the trial was compromised by methodological difficulties. 2012 The Authors. Transfusion Medicine 2012 British Blood Transfusion Society.
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Hemostatic strategies for minimizing mortality in surgery with major blood loss
Johansson PI
Transfusion Alternatives in Transfusion Medicine. 2010;11((Suppl 2):):8. Abstract No. S14.