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Research article
Lian-bo Xiao
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9305-0776
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This work is licensed under a CC BY 4.0 License. Read Full License
Background: To identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who have undergone primary unilateral total knee arthroplasty (TKA).
Methods: For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants aged 50–75 years, with RA who underwent unilateral primary TKA were recruited. The patients received one dose of 1g IV-TXA was 10 min before skin incision, followed by articular injection 1.5 g TXA after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay.
Results: Between September 2019 and May 2020, 104 participants were randomized, but 7 were lost to follow-up. The mean TBL, HBL, and maximum Hb decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. D-dimer level was lower in group B than in group A on postoperative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the two groups (P > 0.05).
Conclusion: In patients with RA, three doses of postoperative IV-TXA further enabled HBL and Hb decrease without increasing the incidence of adverse events in a short period of time after TKA.
Trial registration: The trial was registered in Chinese Clinical Trial Registry (ChiCTR1900025013).
Keywords
Total knee arthroplasty, rheumatoid arthritis, Tranexamic acid, Blood loss
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CURRENT STATUS: Under Revision
Version 2
Posted 16 Sep, 2020
No community comments so far
Editorial decision: Major revision
On 10 Jan, 2021
Review #2 received
Received 07 Jan, 2021
Reviewer #3 agreed
On 05 Jan, 2021
Reviewer #2 agreed
On 30 Nov, 2020
Review #1 received
Received 10 Nov, 2020
Reviewer #1 agreed
On 19 Oct, 2020
Reviewers invited
Invitations sent on 14 Oct, 2020
Editor assigned
On 14 Sep, 2020
Submission checks complete
On 13 Sep, 2020
Editor invited
On 13 Sep, 2020
No comments provided
Editorial decision: Major revision
On 26 Aug, 2020
Review #3 received
Received 22 Aug, 2020
Review #2 received
Received 17 Aug, 2020
Reviewer #3 agreed
On 09 Aug, 2020
Review #1 received
Received 03 Aug, 2020
Reviewer #2 agreed
On 27 Jul, 2020
Reviewers invited
Invitations sent on 16 Jul, 2020
Reviewer #1 agreed
On 16 Jul, 2020
Editor assigned
On 13 Jul, 2020
Submission checks complete
On 12 Jul, 2020
Editor invited
On 12 Jul, 2020
First submitted
On 08 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Orthopedics
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This preprint is under consideration at BMC Musculoskeletal Disorders. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Lian-bo Xiao
Corresponding Author
ORCiD: https://orcid.org/0000-0001-9305-0776
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Revision
Version 2
Posted 16 Sep, 2020
No community comments so far
Editorial decision: Major revision
On 10 Jan, 2021
Review #2 received
Received 07 Jan, 2021
Reviewer #3 agreed
On 05 Jan, 2021
Reviewer #2 agreed
On 30 Nov, 2020
Review #1 received
Received 10 Nov, 2020
Reviewer #1 agreed
On 19 Oct, 2020
Reviewers invited
Invitations sent on 14 Oct, 2020
Editor assigned
On 14 Sep, 2020
Submission checks complete
On 13 Sep, 2020
Editor invited
On 13 Sep, 2020
No comments provided
Editorial decision: Major revision
On 26 Aug, 2020
Review #3 received
Received 22 Aug, 2020
Review #2 received
Received 17 Aug, 2020
Reviewer #3 agreed
On 09 Aug, 2020
Review #1 received
Received 03 Aug, 2020
Reviewer #2 agreed
On 27 Jul, 2020
Reviewers invited
Invitations sent on 16 Jul, 2020
Reviewer #1 agreed
On 16 Jul, 2020
Editor assigned
On 13 Jul, 2020
Submission checks complete
On 12 Jul, 2020
Editor invited
On 12 Jul, 2020
First submitted
On 08 Jul, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Orthopedics
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: To identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who have undergone primary unilateral total knee arthroplasty (TKA).
Methods: For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants aged 50–75 years, with RA who underwent unilateral primary TKA were recruited. The patients received one dose of 1g IV-TXA was 10 min before skin incision, followed by articular injection 1.5 g TXA after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay.
Results: Between September 2019 and May 2020, 104 participants were randomized, but 7 were lost to follow-up. The mean TBL, HBL, and maximum Hb decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. D-dimer level was lower in group B than in group A on postoperative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the two groups (P > 0.05).
Conclusion: In patients with RA, three doses of postoperative IV-TXA further enabled HBL and Hb decrease without increasing the incidence of adverse events in a short period of time after TKA.
Trial registration: The trial was registered in Chinese Clinical Trial Registry (ChiCTR1900025013).
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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