Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05705336 |
Other study ID # |
N0421 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
January 1, 2021 |
Est. completion date |
January 1, 2022 |
Study information
Verified date |
January 2023 |
Source |
National Institute of Rehabilitation, Mexico |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Study design: Randomized control trial Purpose: Evaluate the efficacy of oral administration
of tranexamic acid (TXA) in spine surgeries to achieve blood loss reduction.
Methods. A total of 60 patients undergoing major surgery of the spine, were randomly assigned
into 2 groups. Group 1 was assigned as the control group and the other one included oral
administration of tranexamic acid 2 hours prior to surgery. Outcomes measures included
intraoperative blood loss, postoperative blood loss, hematological parameters, blood
transfusion needed, and surgical complications.
Description:
The study design is a prospective randomized control trial done in a single institution from
2021 to 2022. Approval from the institutional ethics committee was obtained for the study
(number 04/21). Major surgery was defined as "surgeries involving the intervention of more
than 4 levels of the thoracolumbar spine, and with a diagnosis of failed back surgery or,
deformities in the spine". Patients excluded were those with low preoperative hemogram values
(Hb <10mg/dL, low platelet counts (<100 x 109/L), bleeding disorders, coagulopathies, intake
of contraceptives or anticoagulant medication, active thromboembolic disease (deep venous
thromboembolism, chronic venous insufficiency, chronic thromboembolism), fibrinolytic
disorders secondary to consumption coagulopathy, history of thromboembolic or coronary
disease, history of seizure, liver failure, dyslipidemia, congenital coagulopathies (Von
Willebrand Disease, Hemophilia A and B), acquired coagulopathy (Vitamin K deficiency,
disseminated intravascular coagulation) and, thrombocytopenic purpura. Patients in whom
postsurgical hemoglobin was not available, or patients who accidentally removed the drain or
had leaks were eliminated from the study.
General anesthesia was given for all the procedures and surgery was performed by two seniors'
surgeons with over 27 years of experience in spine surgery, standard posterior approach was
utilized in all cases, and all the cases were treated with pedicle screw fixation, at least
one osteotomy and posterolateral or interbody fusion were performed in all the cases. All
cases have been randomly divided into 2 groups.
Interventions:
1. Control group (n=30 cases): 100ml of water, and 3 tablets of placebo pills were
administered 2 hours prior to surgery.
2. PO TXA group (n=30 cases): Single dose of 1950 mg (3 tablets of 650 mg) was administered
orally 2 hours before the surgical incision. The dose was administered by the nurse on
duty who provided 100ml of water to swallow the pills.
For both groups estimation of intraoperative bleeding was calculated by the anesthesiologist
at the end of the surgery, anesthesiologist and surgeons in charge were blinded to the
patient group, the need for transfusion during surgery and the amount of volume to be
transfused was determined by the anesthesiologist. A suction drain was placed deep into the
fascia before closure; the amount of total drainage at 36 hours was recorded. The Suction
drain was constantly kept in suction mode, and it was removed when the output was less than
100ml/24-hour period after postoperative day 1.
Post-operatory transfusion (within the first 48 hours after surgery) was carried out in
patients with hemoglobin <8mg/dL and for patients with clinical symptoms of anemia such as
hypotension and tachycardia.
Clinical data include age, height, weight, BMI, operative time, hemoglobin levels
preoperatively and 24 hours postoperatively, number of spine levels operated, the volume of
blood loss, calculated as intraoperative blood loss plus drainage collection total bleeding,
number of transfusions received (units of transfusions received in the trans operative and
postoperative period), length of stay and, the complication was also analyzed.
Statistical Analysis The qualitative data were presented as numbers and percentages.
Kolmogorov-Smirnov test determined normality of the data. The parametric quantitate data were
presented as mean and standard deviation. Comparison between groups was analyzed by using the
x2 test or Fisher exact test for qualitative data, and the unparaided t-test for quantitative
data. A logistic regression model that included the variables use of oral TXA, sex, BMI, age,
number of levels operated, complication, and time of surgery (mean 230min) was performed.
A multivariate forward stepwise logistic regression model was then used to measure the
adjusted association of these variables with intraoperative transfusion, with significance
set at p<0.05. Data was analyzed using SPSS version 24.0 (IBM COrp, Armonk, NY).