Ascending Aorta Aneurysm Clinical Trial
Official title:
The Hemostatic Potential of TDM-621 on Ascending Aortic Surgery
SASH Trial is a multicenter, prospective, open and randomized 1:1 study. The aim of this study is to evaluate the efficacy of TDM-621(Three-D Matrix- 621) (PuraStat®) on hemostasis of ascending aortic surgery. The TDM-621 is a topic hemostatic product. When in contact with blood it allowed to cover the sutures improving the hemostasis. The hypothesis is that the use of TDM-621 may reduce bleeding and the need for blood transfusion of patients undergoing ascending aortic surgeries. It will include 200 consecutive patients randomized to receive TDM-621 or regular procedure, performed in 5 different centers.
According to data from the National Center for Health Statistics 2013, more than 51 million
surgical procedures with hospitalized patients are conducted annually in the United States.
During and postoperative bleeding is a concern for increasing the morbidity and mortality of
the procedures, in addition to being sometimes associated with the need for reoperation.
During surgery as the earlier hemostasis is achieved, the shorter time of operation, the less
need for transfusion, the better is the handling of the patient and the earlier their
recovery. Therefore, the shorter is the length of stay in the intensive care unit and the
hospitalization, which will result in a reduced costs.
In cardiovascular surgery, especially in aortic operations, whose surgical procedure requires
anticoagulation with heparin, cardiopulmonary bypass, several degrees of hypothermia,
sometimes systemic circulatory arrest, among other tactics in the operative handling, all the
additional resources that may help in the hemostasis are vital to improve the outcomes.
Hemostats or adhesives derived from collagen or hydrogels are products that have been
developed to contain minor, less intense bleeds and act as a barrier of containment when
placed on a bloody surface that in contact with the blood, would help in the formation of the
clot. The sealants are basically divided into the fibrin glues (human or animal origin),
products that mimic the final pathway of the coagulation cascade in the formation of the
fibrin clot. Also there are the synthetic sealants (polyethylene glycol polymers) that form
an adhesive over the applied site.
TDM-621 (PuraStat® component) is an absorbable, local hemostatic agent composed of nanofibers
of a self-supporting polypeptide that forms a hydrogel that, when in contact with blood,
allows the suture vessel wall to be optimized for hemostasis.
The hypothesis is that the use of TDM-621 may reduce bleeding and the need for blood
transfusion of patients undergoing thoracic ascending aortic surgeries.
SASH Trial is a multicenter, prospective, open and randomized 1: 1 study. The aim of this
study is to evaluate the effectiveness of TDM-621 on hemostasis of ascending aortic surgery.
It will be performed in 5 different centers.The study will include 200 patients with
ascending aortic disease according to inclusion criteria.
The protocol, informed consent form and other documents related to the study were submitted
to the Ethics Committee/Institutional Review Board and was approved. The study will be
carried out in accordance with the Declaration of Helsinki and Good Clinical Practices (GCP).
Statistical analysis The sample size for the study was calculated by estimating a reduction
of 400 ml to 500 ml peri-operative bleeding with a standard deviation of ± 250 ml for the
treated group, alpha = 5% and 80% power. To do so, it will take 99 Participants for each
group, totaling 198 Participants for the study.
Categorical variables will be assessed using the chi-square test or Fisher's exact test or
likelihood ratio.
The normality of the quantitative variables will be evaluated with the Shapiro-Wilks test.
The parametric variables will be described with mean and standard deviation and compared with
the t-Student test. Non-parametric variables will be described with median and interquartile
range and compared with the Mann-Whitney test.
Values of p <0.05 will be considered significant.
Data Storage It is expected that all data entered in the eCRF will have source documentation
available in the clinical center. The site must implement processes to ensure that this
happens.
Quality Assurance and Data Management Data collection will be performed through an electronic
CRF (eCRF). The investigator or an authorized member of the research team must sign all
completed eCRFs using an electronic signature (a password will be provided by the data
management center at the beginning of the study). Clinical data management will be performed
according to data cleansing procedures. This is applicable for data recorded in the eCRF, as
well as for data from other sources (eg laboratory tests, ECG, etc.). Proper computer editing
programs will be run to verify the accuracy of the database. The researcher will be asked
about incomplete, inconsistent or absent data.
The study was submitted to the Scientific and Ethics Committee of the five hospitals
involved. The Managing Center, which will determine the independent randomization of the
other Centers, as well as coordinate and audit the data is the Heart Institute (InCor)
University of Sao Paulo General Hospital. A study-specific database will be assembled and
stored on the REDCAP platform.
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