Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement: efficacy and safety of fibrin sealant and tranexamic acid. A randomised controlled clinical trial (TRANEXFER study)

Jordán, Marcos; Aguilera, Xavier García; Gonzalez, Jose; Castillón, Pablo; Salomó, Mónica; Hernández, José Antonio; Ruiz, Leonardo; Mora, J.; Camacho-Carrasco, Pilar; Prat-Fabregat, Salvi; Bosch, Alba Fernández; Rodríguez-Arias, Ainhoa; Martinez‐Zapata, Maria José

doi:10.1007/s00402-018-3089-4

Cited by 24 publications

(19 citation statements)

References 23 publications

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“…The data of postoperative hemoglobin level was reported in three studies [20][21][22]. The current meta-analysis showed that there was a signi cant difference in postoperative hemoglobin level between the FS group and the TXA group during the THA [WMD = -0.47, 95% CI (-0.74, -021), P = 0.0005, I 2 = 3%, Fig.…”

Section: Postoperative Hemoglobin Levelmentioning

confidence: 71%

“…Seventeen studies were excluded after reading the title and abstract. For the remaining nine we screened the full text, and eventually, four studies [19][20][21][22] involving 180 patients were included. The included studies involved 98 patients in the FS group and 81 patients in the TXA group.…”

Section: Study Selection Processmentioning

confidence: 99%

“…Total calculated blood loss Data of total calculated blood loss was provided in three studies [19,[21][22]; the pooled outcomes demonstrated that there were no signi cant differences between the FS group and the TXA group during THA [WMD = -86.22, 95% CI (-99.13, -73.31), P < 0.00001, I 2 = 96%, Fig. 3] in the presence of statistical heterogeneity (I 2 = 95 %).…”

Section: Risk Of Bias Assessmentmentioning

confidence: 99%

“…Blood transfusion rate data were provided in three studies [20][21][22]. The meta-analysis demonstrated that there were no signi cant differences in blood transfusion rate [RD = -0.12, 95% CI (-0.23, -0.00), P = 0.05, I 2 = 74%, Fig.…”

Section: Blood Transfusion Ratementioning

confidence: 99%

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The Efficacy and Safety of Fibrin Sealant Versus Tranexamic Acid Administration in Patients Undergoing Hip Arthroplasty: A Meta-analysis

Yong¹,

Deng²,

Nan³

et al. 2020

Preprint

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PurposeThe efficacy and safety of topical fibrin sealant (FS) compared with tranexamic acid (TXA) to reduce blood loss after total hip arthroplasty (THA) is not clear. A meta-analysis was conducted to evaluate the efficacy and safety of topical FS versus topical or intravenous TXA for treatment of primary THA.MethodWe searched electronic databases, including PubMed, Embase, and the Cochrane Library to identify studies up to March 2020. The references included in articles were also checked for additional potentially-relevant studies. The language of publication was limited to English. The endpoints included the mean difference (MD) of blood loss, hemoglobin value, and odds ratios (ORs) of transfusion requirements and thrombotic events. Our meta-analysis was performed according to the Guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. The data of the included studies were analyzed using RevMan 5.3.ResultsA total of four studies (two randomized controlled trials and two non-randomized controlled trials) met the inclusion criteria. Our meta-analysis demonstrated that TXA administration led to significantly different outcomes in terms of transfusion rate (RD = -0.12, 95% CI (-0.23, -0.00), P = 0.05, I2 = 74%) and postoperative hemoglobin levels (WMD = -0.47, 95% CI (-0.74, -021), P = 0.0005, I2 = 3%) compared with topical application of FS in patients undergoing THA. No significant difference was seen in total calculated blood loss (WMD = -86.22, 95% CI (-99.13, -73.31), P < 0.00001, I2 = 96%) or complication rate (RR = 0.98, 95% CI (-99.13, -73.31), P = 0.45, I2 = 0%) between the two groups.ConclusionsTXA administration can effectively decrease the transfusion rate and result in higher postoperative hemoglobin levels without increasing the rate of infection.

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Section: Postoperative Hemoglobin Levelmentioning

confidence: 71%

Section: Study Selection Processmentioning

confidence: 99%

Section: Risk Of Bias Assessmentmentioning

confidence: 99%

Section: Blood Transfusion Ratementioning

confidence: 99%

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The Efficacy and Safety of Fibrin Sealant Versus Tranexamic Acid Administration in Patients Undergoing Hip Arthroplasty: A Meta-analysis

Yong¹,

Deng²,

Nan³

et al. 2020

Preprint

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show abstract

“…Several clinical trials on the application of topical FS and TXA in THA have been implemented [19][20][21][22]. Kearns et al [22] concluded that the use of TXA signi cantly reduced blood-transfusion requirements and preserved higher hemoglobin levels in patients undergoing THA compared with topical FS. Mahmood et al [20] conducted a clinical trial that obtained similar outcomes.…”

Section: Discussionmentioning

confidence: 99%

The Efficacy and Aafety of Fibrin Sealant Versus Tranexamic Acid Administration in Patients Undergoing Hip Arthroplasty: A Meta-Analysis.

Fan

Hong

Deng

et al. 2020

Preprint

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Purpose: The efficacy and safety of topical fibrin sealant (FS) compared with tranexamic acid (TXA) to reduce blood loss after total hip arthroplasty (THA) is not clear. A meta-analysis was conducted to evaluate the efficacy and safety of topical FS versus topical or intravenous TXA for treatment of Method: We searched electronic databases, including PubMed, EMBASE, and the Cochrane Library to identify studies up to March 2020. The references included in articles were also checked for additional potentially-relevant studies. The language of publication was limited to English. The endpoints included the mean difference (MD) of blood loss, hemoglobin value, and odds ratios (ORs) of transfusion requirements and thrombotic events. Our meta-analysis was performed according to the Guidelines of the Cochrane Reviewer's Handbook and the PRISMA statement. The data of the included studies were analyzed using RevMan 5.3.Results: A total of four studies (two randomized controlled trials and two non-randomized controlled trials) met the inclusion criteria. Our meta-analysis demonstrated that TXA administration led to significantly different outcomes in terms of transfusion rate (RD = -0.12, 95% CI (-0.23, -0.00), P = 0.05, I2 = 74%) and postoperative hemoglobin levels (WMD = -0.47, 95% CI (-0.74, -021), P = 0.0005, I2 = 3%) compared with topical application of FS in patients undergoing THA. No significant difference was seen in total calculated blood loss (WMD = -86.22, 95% CI (-99.13, -73.31), P < 0.00001, I2 = 96%) or complication rate (RR = 0.98, 95% CI (-99.13, -73.31), P = 0.45, I2 = 0%) between the two groups.Conclusions: TXA administration can effectively decrease the transfusion rate and result in higher postoperative hemoglobin levels without increasing the rate of infection.

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Pharmacological interventions for the prevention of bleeding in people undergoing definitive fixation or joint replacement for hip, pelvic and long bone fractures

Gibbs

Champaneria

Geneen

et al. 2023

Cochrane Database of Systematic Reviews

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Background Pelvic, hip, and long bone fractures can result in significant bleeding at the time of injury, with further blood loss if they are treated with surgical fixation. People undergoing surgery are therefore at risk of requiring a blood transfusion and may be at risk of peri‐operative anaemia. Pharmacological interventions for blood conservation may reduce the risk of requiring an allogeneic blood transfusion and associated complications. Objectives To assess the effectiveness of different pharmacological interventions for reducing blood loss in definitive surgical fixation of the hip, pelvic, and long bones. Search methods We used a predefined search strategy to search CENTRAL, MEDLINE, PubMed, Embase, CINAHL, Transfusion Evidence Library, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) from inception to 7 April 2022, without restrictions on language, year, or publication status. We handsearched reference lists of included trials to identify further relevant trials. We contacted authors of ongoing trials to acquire any unpublished data. Selection criteria We included randomised controlled trials (RCTs) of people who underwent trauma (non‐elective) surgery for definitive fixation of hip, pelvic, and long bone (pelvis, tibia, femur, humerus, radius, ulna and clavicle) fractures only. There were no restrictions on gender, ethnicity, or age. We excluded planned (elective) procedures (e.g. scheduled total hip arthroplasty), and studies published since 2010 that had not been prospectively registered. Eligible interventions included: antifibrinolytics (tranexamic acid, aprotinin, epsilon‐aminocaproic acid), desmopressin, factor VIIa and XIII, fibrinogen, fibrin sealants, and non‐fibrin sealants. Data collection and analysis Two review authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using GRADE. We did not perform a network meta‐analysis due to lack of data. Main results We included 13 RCTs (929 participants), published between 2005 and 2021. Three trials did not report any of our predefined outcomes and so were not included in quantitative analyses (all were tranexamic acid versus placebo). We identified three comparisons of interest: intravenous tranexamic acid versus placebo; topical tranexamic acid versus placebo; and recombinant factor VIIa versus placebo. We rated the certainty of evidence as very low to low across all outcomes. Comparison 1. Intravenous tranexamic acid versus placebo Intravenous tranexamic acid compared to placebo may reduce the risk of requiring an allogeneic blood transfusion up to 30 days (RR 0.48, 95% CI 0.34 to 0.69; 6 RCTs, 457 participants; low‐certainty evidence) and may result in little to no difference i...

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Prevention of postoperative bleeding in hip fractures treated with prosthetic replacement: efficacy and safety of fibrin sealant and tranexamic acid. A randomised controlled clinical trial (TRANEXFER study)

Cited by 24 publications

References 23 publications

The Efficacy and Safety of Fibrin Sealant Versus Tranexamic Acid Administration in Patients Undergoing Hip Arthroplasty: A Meta-analysis

The Efficacy and Safety of Fibrin Sealant Versus Tranexamic Acid Administration in Patients Undergoing Hip Arthroplasty: A Meta-analysis

The Efficacy and Aafety of Fibrin Sealant Versus Tranexamic Acid Administration in Patients Undergoing Hip Arthroplasty: A Meta-Analysis.

Pharmacological interventions for the prevention of bleeding in people undergoing definitive fixation or joint replacement for hip, pelvic and long bone fractures

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