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Transamin's benefit in decreasing blood loss in knee prosthesis patients

Efficacy of tranexamic acid in reducing bleeding in patients undergoing total knee arthroplasty

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4dvhts
Enrollment
Unknown
Registered
2019-10-16
Start date
2017-01-21
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tranexamic acid

Interventions

Thirty-four patients were randomized into 17 blocks of 2 patients on November 16, 2016. After statistical calculation of the sample, 34 patients were divided into 17 blocks of two equal groups without
The patients were weighed in kilograms and their heights were measured in centimeters. The patients underwent spinal anesthesia and received a prophylactic antibiotic dose - 2 g cefazolin and a 1 g bo
Drug
Procedure/surgery

Sponsors

Fundacao Hospital Adriano Jorge
Lead Sponsor
Fundacao Hospital Adriano Jorge
Collaborator

Eligibility

Age
55 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients were regularly enrolled in the institution where the study was performed with a classic indication of TKA, recommended by Camanho: medial or lateral clamping with obliteration of the joint space, deviations in femoro-tibial varus greater than 15º; deviations in femoro-tibial valgus greater than 10º; femorotibial subluxation in the frontal plane greater than 10 mm; anteriorization of the tibia in relation to the femur in the profile radiography; severe involvement of two of the three knee joint compartments (femorotibial medial, femorotibial lateral or femoropatellar), and failure of conservative treatment for at least three months, when these criteria were not fulfilled. Patients with primary degenerative knee OA; for this evaluation, the patients with stage of knee arthrosis III were considered, according to Ählback, modified by Keys

Exclusion criteria

Exclusion criteria: Patients who underwent knee prosthesis revision surgery, who did not use medial articular access, patients not operated by the senior surgeon, patients with rheumatoid arthritis, multiple scars, and those who refused to sign or did not understand were excluded from the study. TCLE. Any patient with decompensated diabetes mellitus (fasting glycemia> 140 mg / dL), uncontrolled systemic hypertension (SBP > 200 mmHg), peripheral vascular disease, previous thromboembolic events, acute myocardial infarction, neoplasia, active infection, rheumatoid arthritis, obese with (American Society of Anesthesiologists - ASA score> III) and use of anticoagulants had their clinical condition reassessed and surgical procedure postponed. Patients who declared themselves indigenous

Design outcomes

Primary

MeasureTime frame
The use of tranexamic acid is expected to reduce postoperative bleeding after total knee arthroplasty. When blood loss was compared with the groups treated with and without tranexamic acid that underwent total knee arthroplasty (Blood volume in the suction drain was measured serially at three, six, 12, and 14 hours after surgery). ). In all periods measured after surgery, there was a greater bleeding in Group II patients, but with statistically significant difference at three, six and 12 hours (p <0.05)

Secondary

MeasureTime frame
When hematocrit drop was compared between the preoperative and the fifth postoperative day, there was a fall of six points in Group I and 9.1 points in Group II, when the comparison was made between groups in the At the same time, no statistically significant differences were observed (p = 0.417). On the fifteenth day we observed an improvement in hematimetric levels;When hemoglobin was compared between the preoperative and the fifth postoperative day, there was a decrease of 2.1 points in Group I and 3.2 points in Group II, when the comparison was made between groups. At the same time, no statistically significant differences were observed (p = 0.203). On the fifteenth day we observed an improvement in hemoglobin levels;No statistically significant differences were observed on the fifth and 15th. postoperative days (p = 0.842 and p = 0.863, respectively) in relation to the estimated blood volume. To calculate the estimated blood volume of the patients, we used the formula described by Nadler et al.;The estimated blood loss was also calculated according to the suggestion of Mercuriali and Inghilleri, and there was a greater loss in Group II when verified in the 15th. postoperative day (p = 0.033). On the fifth postoperative day, there was greater bleeding in Group II, but without statistical significance (p = 0.206);Tukey's test (ANOVA) showed a significant decrease in hematocrit and hemoglobin (p <0.001), but no differences in the estimated blood volume of patients (p = 0.841 for Group I and p = 0.762). When comparing the hematocrit, hemoglobin and blood volume of patients undergoing TKA in relation to the preoperative period, 5º. and 15th. days after surgery in Groups I and II

Countries

Brazil

Contacts

Public ContactMarcos Souza Leao

Fundacao Hospital Adriano Jorge

mgselao@uol.com.br+55-92-981286708

Outcome results

None listed

Source: REBEC (via WHO ICTRP)