Condition or disease | Intervention/treatment | Phase |
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Ascending Aorta Abnormality Ascending Aortic Dissection Ascending Aorta Aneurysm | Combination Product: TDM-621 | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | SASH Trial is a multicenter, prospective, open and randomized 1:1 study. Will be included 200 consecutive patients randomized to receive TDM-621 or regular procedure. It will be performed in 5 different centers. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Hemostatic Potential of TDM-621 on Ascending Aortic Surgery |
Actual Study Start Date : | December 4, 2018 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |
Arm | Intervention/treatment |
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No Intervention: Control
This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques.
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Active Comparator: TDM-621
This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques and will receive the TDM-621 for complementary hemostasis.
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Combination Product: TDM-621
The TDM-621 is a topic hemostatic product which will be used during ascending aortic surgery.
Other Name: PuraStat®
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ricardo R Dias, MD,PhD | 551126615075 | ricardo.dias@incor.usp.br | |
Contact: Felix José A Ramires, MD,PhD | 551126615057 | felix.ramires@incor.usp.br |
Brazil | |
Heart Institute (InCor) University of Sao Paulo | Recruiting |
São Paulo, Brazil, 05403000 | |
Contact: Ricardo R Dias, MD, PhD 551126615075 ricardo.dias@incor.usp.br | |
Contact: Felix José A Ramires, MD, PhD 551126615057 felix.ramires@incor.usp.br |
Study Chair: | Ricardo R Dias, MD,PhD | Instituto do Coração - INCORHCFMUSP |
Tracking Information | |||||
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First Submitted Date ICMJE | February 5, 2019 | ||||
First Posted Date ICMJE | April 17, 2019 | ||||
Last Update Posted Date | April 17, 2019 | ||||
Actual Study Start Date ICMJE | December 4, 2018 | ||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Strategy for Aortic Surgery Hemostasis | ||||
Official Title ICMJE | The Hemostatic Potential of TDM-621 on Ascending Aortic Surgery | ||||
Brief Summary | 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. | ||||
Detailed Description |
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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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: SASH Trial is a multicenter, prospective, open and randomized 1:1 study. Will be included 200 consecutive patients randomized to receive TDM-621 or regular procedure. It will be performed in 5 different centers. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Combination Product: TDM-621
The TDM-621 is a topic hemostatic product which will be used during ascending aortic surgery.
Other Name: PuraStat®
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
200 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2020 | ||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Brazil | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03917862 | ||||
Other Study ID Numbers ICMJE | 93960818.9.1001.0068 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Ricardo Ribeiro Dias, University of Sao Paulo General Hospital | ||||
Study Sponsor ICMJE | University of Sao Paulo General Hospital | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Sao Paulo General Hospital | ||||
Verification Date | April 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |