Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total hip arthroplasty: results of a randomized controlled trial (TRAC-24)

2021 ◽  
Vol 103-B (7) ◽  
pp. 1197-1205
Author(s):  
Paul Magill ◽  
J. C. Hill ◽  
Leeann Bryce ◽  
Una Martin ◽  
Al Dorman ◽  
...  
Keyword(s):  
High Risk ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Controlled Trial ◽  
Reduce Blood Loss ◽  
Randomized Controlled ◽  
History Of ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Aims A typical pattern of blood loss associated with total hip arthroplasty (THA) is 200 ml intraoperatively and 1.3 l in the first 48 postoperative hours. Tranexamic acid (TXA) is most commonly given as a single preoperative dose only and is often withheld from patients with a history of thromboembolic disease as they are perceived to be “high-risk” with respect to postoperative venous thromboembolism (VTE). The TRanexamic ACid for 24 hours trial (TRAC-24) aimed to identify if an additional 24-hour postoperative TXA regime could further reduce blood loss beyond a once-only dose at the time of surgery, without excluding these high-risk patients. Methods TRAC-24 was a prospective, phase IV, single centre, open label, parallel group, randomized controlled trial (RCT) involving patients undergoing primary unilateral elective THA. The primary outcome measure was the indirect calculated blood loss (IBL) at 48 hours. The patients were randomized into three groups. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional oral regime for 24 hours postoperatively, group 2 only received the intraoperative dose, and group 3 did not receive any TXA. Results A total of 534 patients were randomized, with 233 in group 1, 235 in group 2, and 66 in group 3; 92 patients (17.2%) were considered high-risk. The mean IBL did not differ significantly between the two intervention groups (848.4 ml (SD 463.8) for group 1, and 843.7 ml (SD 478.7) for group 2; mean difference -4.7 ml (95% confidence interval -82.9 to 92.3); p = 0.916). No differences in mortality or incidence of VTE were observed between any group. Conclusion The addition of oral TXA for 24 hours postoperatively does not reduce blood loss beyond that achieved with a single 1 g IV perioperative dose alone. There may be a clinically relevant difference in patients with a normal BMI, which warrants further investigation. Critically, there were no safety issues in patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(7):1197–1205.

Oral tranexamic acid for an additional 24 hours postoperatively versus a single preoperative intravenous dose for reducing blood loss in total knee arthroplasty: results of a randomized controlled trial (TRAC-24)

2021 ◽  
Vol 103-B (10) ◽  
pp. 1595-1603
Author(s):  
Paul Magill ◽  
Janet C. Hill ◽  
Leeann Bryce ◽  
Una Martin ◽  
Al Dorman ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Blood Loss ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
History Of ◽  
Total Knee ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Aims In total knee arthroplasty (TKA), blood loss continues internally after surgery is complete. Typically, the total loss over 48 postoperative hours can be around 1,300 ml, with most occurring within the first 24 hours. We hypothesize that the full potential of tranexamic acid (TXA) to decrease TKA blood loss has not yet been harnessed because it is rarely used beyond the intraoperative period, and is usually withheld from ‘high-risk’ patients with a history of thromboembolic, cardiovascular, or cerebrovascular disease, a patient group who would benefit greatly from a reduced blood loss. Methods TRAC-24 was a prospective, phase IV, single-centre, open label, parallel group, randomized controlled trial on patients undergoing TKA, including those labelled as high-risk. The primary outcome was indirect calculated blood loss (IBL) at 48 hours. Group 1 received 1 g intravenous (IV) TXA at the time of surgery and an additional 24-hour postoperative oral regime of four 1 g doses, while Group 2 only received the intraoperative dose and Group 3 did not receive any TXA. Results Between July 2016 and July 2018, 552 patients were randomized to either Group 1 (n = 241), Group 2 (n = 243), or Group 3 (n = 68), and 551 were included in the final analysis. The blood loss did differ significantly between the two intervention groups (733.5 ml (SD 384.0) for Group 1 and 859.2 ml (SD 363.6 ml) for Group 2; mean difference -125.8 ml (95% confidence interval -194.0 to -57.5; p < 0.001). No differences in mortality or thromboembolic events were observed in any group. Conclusion These data support the hypothesis that in TKA, a TXA regime consisting of IV 1 g perioperatively and four oral 1 g doses over 24 hours postoperatively significantly reduces blood loss beyond that achieved with a single IV 1 g perioperative dose alone. TXA appears safe in patients with history of thromboembolic, cardiovascular, and cerebrovascular disease. Cite this article: Bone Joint J 2021;103-B(10):1595–1603.

Comparison of Incidence of Neonatal Anemia in Different Timing of Delayed Cord Clamping; at 30 Seconds, 1 Minute and 2 Minutes in Term Vaginal Delivery: A Randomized Controlled Trial

2020 ◽  
Vol 103 (12) ◽  
pp. 1255-1261
Keyword(s):  
Blood Loss ◽  
Controlled Trial ◽  
Controlled Study ◽  
Delayed Cord Clamping ◽  
Randomized Controlled ◽  
Cord Clamping ◽  
Estimated Blood Loss ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: To compare the effect of cord clamping time on the incidence of neonatal anemia, clinical outcomes, and maternal and neonatal complications in term vaginal delivered newborns. Materials and Methods: A randomized controlled study was undertaken. Two hundred forty healthy full term vaginal delivered newborns were randomly allocated to either 30-seconds, 1-minute, or 2-minutes groups (group 1, 2, and 3) of umbilical cord clamping. During the interval between delivery and cord clamping, the attendant held the neonate supine at the level of the introitus. Neonatal venous hematocrit (Hct) was measured at 48 to 72 hours after birth. Results: Two hundred thirty newborns completed the present study. Neonatal anemia (Hct less than 45%) was detected in six of 77 cases (7.8%) in group 1, five of 76 cases (6.6%) in group 2, and three of 77 case (3.9%) in group 3, and there were no significant differences among the groups. Mean venous hematocrit values at 48 to 72 hours of life ± standard deviations were 53.1±6.4% in group 1, 53.0±5.5% in group 2, and 53.0±5.7% in group 3. The incidence of polycythemia (hematocrit more than 65%) and neonatal jaundice were similar among all the groups. There were no significant differences in the estimated postpartum blood loss and other neonatal outcomes. Conclusion: Neonatal hematocrit was not significantly different following delayed cord clamping (DCC) at 30-seconds, 1-minute, and 2-minutes, but the incidence of neonatal anemia decreased with the longer timing of DCC. The estimated blood loss and other complications were not different between the groups. Therefore, a minimum of a one minute DCC should be considered for neonatal anemic prevention when compared with the 30-seconds DCC. Keywords: Delayed cord clamping, Timing, Hematocrit, Neonatal anemia

scholarly journals Randomized controlled trial of three oxytocic regimens to prevent primary postpartum haemorrhage at caesarean section

Mediscope ◽  
2017 ◽  
Vol 4 (2) ◽  
pp. 5-11
Author(s):  
AJ Peea ◽  
F Begum ◽  
E Saha
Keyword(s):  
Randomized Controlled Trial ◽  
Side Effects ◽  
Caesarean Section ◽  
Blood Loss ◽  
Postpartum Haemorrhage ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

The objective of this present study was to compare the efficacy of three oxytocic regimens to prevent primary postpartum haemorrhage (PPH) at caesarean section. A randomized controlled trial including 90 patients who underwent caesarean section were selected according to inclusion and exclusion criteria assigned randomly into three groups (30 patients in each group) was conducted. Group 1 and group 2 were exposure groups and group 3 was control group. All patients were given 10 units intravenous (IV) bolus oxytocin immediately after delivery of baby. Group 1 was given additional 20 units oxytocin in each 1000 ml fluid for 24 hours. Group 2 received additional 1000 microgram misoprostol per rectal. Group 3 did not receive any additional oxytocic drug. Background characteristics of all the three groups were similar. It was observed that 501-1000 ml blood loss was found among 25 (83.3%) cases in group 1, 27 (90.0%) in group 2 and 27 (90.0%) in group 3. The mean (SD) amount of blood loss was found 733 (190) ml in group 1792 (187) ml in group 2 and 818 (14) ml in group 3. Occurrence of PPH and blood transfusion needed among 1 (3.3%) in group 1, 2 (6.7%) in group 2 and 3 (10.0%) in group 3. Side effects occurred in 7 (23.3%) patients of group 1, 18 (60.0%) in group 2, and 6 (20.0%) in group 3. Shivering was found among 4 (13.3%) in group 1, 10 (33.3%) in group 2 and 3 (10%) in group 3. Vomiting was found among 2 (6.7%) in group 1, 4 (13.3%) in group 2, and 2 (6.7%) in group 3. Pyrexia was 1 (3.3%) in group 1, 4 (13.3%) in group 2 and 1 (3.3%) in group 3. Side effects were more in the group where misoprostol was used. Except side effects there was no statistical difference of occurrence of different events among the three groups. Only bolus IV oxytocin appears to be as effective as oxytocin infusion in addition to bolus IV oxytocin or per rectal misoprostol in addition to bolus IV oxytocin to prevent primary PPH at caesarean section. But occurrence of transient side effects such as shivering, pyrexia and vomiting were noted more frequently with the use of misoprostol.Mediscope Vol. 4, No. 2: Jul 2017, Page 5-11

Effect of Chlorhexidine Cleansing of Umbilical Cord for Prevention of Infection

2018 ◽  
Vol 4 (2) ◽  
pp. 35-39
Author(s):  
Md Khairuzzaman ◽  
MA Mannan ◽  
Abdul Matin ◽  
Mst Monjuman Ara Sarker ◽  
Nihar Ranjan Sarker ◽  
...  
Keyword(s):  
Umbilical Cord ◽  
Controlled Trial ◽  
Care Group ◽  
Cord Care ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
To Receive ◽  
Level Hospital ◽  
Group 1

Background: Chlorhexidine cleansing of the cord can reduce neonatal mortality among newborns.Objective: The aim of study was to determine the effect of cord cleansing with chlorhexidine in reduction of umbilical infection among newborns in hospital settings.Methodology: This randomized controlled trial was carried out between April 2013 to July 2014 and 510 newborns were randomly assigned within a tertiary level hospital in Bangladesh to receive 1 of 3 cord care regimens single cord cleansing with 4% chlorhexidine(Group-1), multiple cord cleansing with 4% chlorhexidine (Group-2)  and clean and dry cord care (Group-3 : control).Results: The risk of umbilical cord infection (omphalitis) was significantly reduced in both the single (Relative risk [RR] 0.15 [95% CI] 0.008-0.93) and multiple chlorhexidine cleansing group (RR 0.37 [95% CI] 0.04- 0.99) compared to the dry cord care group.  The risk of omphalitis was not significantly different between multiple and single chlorhexidine cleansing group (RR 3.14 [0.13-76.54]). Conclusion: Chlorhexidine significantly reduce the risk of umbilical infection in both single and multiple cord cleansing neonates.Bangladesh Journal of Infectious Diseases 2017;4(2):35-39

Fibrin gel versus papain gel in the healing of chronic venous ulcers: A double-blind randomized controlled trial

2016 ◽  
Vol 32 (7) ◽  
pp. 488-495 ◽  
Author(s):  
Illymack CF de Araújo ◽  
Elenice Defune ◽  
Luciana PF Abbade ◽  
Hélio A Miot ◽  
Matheus Bertanha ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Efficacy And Safety ◽  
Fibrin Gel ◽  
Double Blind ◽  
Randomized Controlled ◽  
Carbopol Gel ◽  
Venous Ulcers ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objectives Compare the efficacy and safety of fibrin gel to 8% papain gel for wound dressing of venous ulcers. Method Patients with chronic venous ulcers were randomly assigned to one in three groups: Group 1—fibrin gel; Group 2—8% papain gel; Group 3—carbopol gel (control). Patients were seen every 15 days during 2 months, verifying reduction of the ulcer area, local infection, exudation, and epithelization. All serious or nonserious adverse events were recorded. Results Fifty-five patients (total of 63 ulcers) were randomly distributed in three groups (G1 = 21; G2 = 19; G3 = 23). No patient was excluded or discontinued treatment throughout the study. The areas of the ulcers were similarly reduced in all groups (14.3%, 21.1%, and 30.4% in groups 1, 2, and 3, respectively), and all had significant reduction in exudation and contamination. Conclusion The data demonstrate that neither fibrin gel nor papain gel were able to improve the process of ulcer-healing, as compared to control.

scholarly journals Use of Fecal transplantation with a novel diet for mild to moderate active ulcerative colitis: The CRAFT UC randomized controlled trial

2021 ◽  
Author(s):  
Chen Sarbagili Shabat ◽  
Franco Scaldaferri ◽  
Eran Zittan ◽  
Ayal Hirsch ◽  
Maria Chiara Mentella ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mucosal Healing ◽  
Fecal Transplantation ◽  
Randomized Controlled ◽  
Single Donor ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background We evaluated whether integration of novel diets for donors and patients in addition to fecal transplantation (FT) could increase FT remission rate in refractory ulcerative colitis (UC). Methods This was a blinded randomized controlled trial in adults with active UC, defined by a simple clinical colitis activity index (SCCAI) of ≥5 and ≤ 11 and endoscopic Mayo score 2-3, refractory to medication. Group 1 received free diet and single donor standard FT by colonoscopy on day 1and rectal enemas on days 2 and 14 without dietary conditioning of the donor. Group 2: FT as above but with dietary pre-conditioning of the donor for 14 days and a UC Exclusion Diet (UCED) for the patients. Group 3 received the UCED alone. The primary endpoint was week 8 clinical steroid free remission, defined as SCCAI &lt;3. Results Sixty two of 96 planned patients were enrolled. Remission week 8 Group 1 was 2/17 (11.8%), Group 2 4/19 (21.1%), Group 3 6/15 (40%) (NS). Endoscopic remission was Group 1 2/17 (12%), Group 2 3/19 (16%), Group 3 4/15 (27%) (Group 1 vs.3 p=0.38). Mucosal healing (Mayo 0) was achieved only in Group 3 (3/15, 20%) vs. 0/36 FT patients (p=0.022). Exacerbation of disease occurred in 3/17 (17.6%) Group 1, 4/19 (21.1%) Group 2, and 1/15 (6.7%) Group 3 (Group 2 vs.3, p=0.35). Conclusions UCED alone appeared to achieve higher clinical remission and mucosal healing than single donor FT with or without diet. The study was stopped for futility by a safety monitoring board.

scholarly journals The benefit of Curcuma longa and Boswellia serrata to improve quality of life in osteoarthritis patients: a randomized controlled trial

2019 ◽  
Vol 5 (6) ◽  
pp. 1005
Author(s):  
Rizaldy Taslim Pinzon ◽  
Rosa De Lima Renita Sanyasi ◽  
Esdras Ardi Pramudita ◽  
Septian Dewi Periska
Keyword(s):  
Curcuma Longa ◽  
Controlled Trial ◽  
Usual Activity ◽  
Boswellia Serrata ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
Anxiety Depression ◽  
Group 1

<p class="abstract"><strong>Background:</strong> Quality of life (QoL) can be affected by chronic pain in osteoarthritis (OA). Previous studies showed that combination of <em>Curcuma longa</em> (CL) and <em>Boswellia serrata</em> (BS) extract (CB extract) are promising for alternative treatment for pain in OA. This study aimed to measure the benefit of CB extract to improve QoL in patients with OA.</p><p class="abstract"><strong>Methods:</strong> This was a randomized controlled trial (RCT) in OA patients. Subjects were randomized to 3 different group (Group 1: CB extract (350 mg of CL and 150 mg BS) and NSAID (400 mg ibuprofen or 50 mg diclofenac sodium); group 2: CB extract; group 3: NSAID). Each medication was taken two times per day for 4 weeks. QoL measured using 5Q-5D-5L that include five dimensiones in 5Q-5D: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, with 5 levels of severity.<strong></strong></p><p class="abstract"><strong>Results:</strong> There were 105 subjects at baseline. After 4 weeks of study, remained 95 subjects. The most common problem in group 1, 2, and 3 was pain (n=23, n=8, n=15 respectively). The improvement of level of severity in group 1 after 4 weeks of treatment was significant in mobility problems (p=0.002), pain/discomfort (p&lt;0.001), and anxiety/depression (p=0.008). A significant improvement was only seen in usual activity problems (p=0.013) in group 2. The decrease of level of severity in usual activity problems (p=0.034), pain/discomfort (p=0.005), and anxiety/depression (p=0.018) in group 3 were also statistically significant.</p><p class="abstract"><strong>Conclusions:</strong> CB extract was beneficial to improve QoL in OA patients with a less side effect compared to NSAID.</p>

Importance of tranexamic acid in pediatric monosutural craniosynostosis surgery

2021 ◽  
pp. 1-7
Keyword(s):  
Length Of Stay ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Median Volume ◽  
Group 3 ◽  
Time Periods ◽  
Group 2 ◽  
Group 1

OBJECTIVE Tranexamic acid (TXA) is an antifibrinolytic drug that has achieved significant reduction in perioperative blood loss and the quantity of blood transfused in many pediatric surgical procedures, without morbidity. Despite the accumulation of evidence regarding its effectiveness in craniosynostosis repair surgery, TXA is not unanimously employed by pediatric neurosurgery teams. The purpose of this study was to evaluate the impact of the routine use of TXA in a homogeneous population of children who underwent open surgery for monosutural craniosynostosis. METHODS The authors retrospectively reviewed 3 cohorts of patients that were subdivided from 2 cohorts surrounding the initiation of TXA (group 1, TXA− [2008–2011] and group 2, TXA+ [2011–2013]) and a third cohort of more recent patients (group 3, TXA+ [2016–2017]). TXA was administered using the same protocol comprising a loading dose of 10 mg/kg over 15 minutes after induction of general anesthesia followed by a 10 mg/kg per hour infusion until skin closure. Patients in all 3 groups underwent similar standardized procedures for scaphocephaly, trigonocephaly, and unicoronal craniosynostosis by the same pediatric neurosurgeon. RESULTS Overall, 102 infants were included in the study: 32 infants in group 1, 36 in group 2, and 34 in group 3. Significant reductions in transfusion of packed erythrocytes (PE) and fresh-frozen plasma (FFP) were observed between the TXA− and TXA+ time periods. The median volume of PE transfusion was reduced by > 50% with the use of TXA (42.8 mL/kg in the TXA− group vs 20.0 in the TXA+ groups, p < 0.0001). Reduction in PE transfusion was 100% postoperatively in the TXA+ groups (20.0 mL/kg in the TXA− group vs 0.0 in the TXA+ groups, p < 0.0001). The median volume of FFP transfusion was reduced by 100% with the use of TXA (12.8 mL/kg in the TXA− group vs 0.0 in the TXA+ groups, p < 0.0001). All children in group 1 received a transfusion, whereas 3 children (8%) and 7 children (20%) in groups 2 and 3, respectively, did not. Significant reductions in postoperative drain output were also noted between the TXA− and TXA+ time periods. The total hospital length of stay was significantly lower in the TXA+ groups (p < 0.0001). CONCLUSIONS Use of TXA reduced blood loss and the need for transfusions but also decreased the hospital length of stay and, thus, minimized overall medical care costs. Intraoperative administration of TXA in craniosynostosis repair surgery should be routinely used in all centers that practice these procedures.

A Randomized, Controlled Trial of Chlorhexidine-Soaked Cloths to Reduce Methicillin-Resistant and Methicillin-SusceptibleStaphylococcus aureusCarriage Prevalence in an Urban Jail

2014 ◽  
Vol 35 (12) ◽  
pp. 1466-1473 ◽  
Author(s):  
Michael Z. David ◽  
Jane D. Siegel ◽  
Janet Henderson ◽  
Greg Leos ◽  
Kaming Lo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Reduction ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Absolute Risk Reduction ◽  
Methicillin Resistant ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective.To assess an intervention to limit community-associated methicillin-resistantStaphylococcus aureus(MRSA) dissemination.Design.Randomized, controlled trial.Setting.County Jail, Dallas, Texas.Participants.A total of 4,196 detainees in 68 detention tanks.Methods.Tanks were randomly assigned to 1 of 3 groups: in group 1, detainees received cloths that contained chlorhexidine gluconate (CHG) to clean their entire skin surface 3 times per week for 6 months; group 2 received identical cloths containing only water; and group 3 received no skin treatment. During the study, all newly arrived detainees were invited to enroll. Nares and hand cultures were obtained at baseline and from all current enrollees at 2 and 6 months.Results.At baseline,S. aureuswas isolated from 41.2% and MRSA from 8.0% (nares and/or hand) of 947 enrollees. The average participation rate was 47%. At 6 months, MRSA carriage was 10.0% in group 3 and 8.7% in group 1 tanks (estimated absolute risk reduction [95% confidence interval (CI)], 1.4% [−4.8% to 7.1%];P= .655). At 6 months, carriage of anyS. aureuswas 51.1% in group 3, 40.7% in group 1 (absolute risk reduction [95% CI], 10.4% [0.01%–20.1%];P= .047), and 42.8% (absolute risk reduction [95% CI], 8.3% [−1.4% to 18.0%];P= .099) in group 2.Conclusions.Skin cleaning with CHG for 6 months in detainees, compared with no intervention, significantly decreased carriage ofS. aureus, and use of water cloths produced a nonsignificant but similar decrease. A nonsignificant decrease in MRSA carriage was found with CHG cloth use.Trial registration.ClinicalTrials.gov identifier NCT00785200.

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