Ascending Aorta AbnormalityPhase 2/3SASHNCT03917862
Strategy for Aortic Surgery Hemostasis
A Phase 2/3 study testing TDM-621 in people with Ascending Aorta Abnormality and Ascending Aortic Dissection, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascending Aorta Abnormality, Ascending Aortic Dissection, Ascending Aorta Aneurysm
- What is being tested?
- TDM-621
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Dec 2018to Dec 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be over 18 years old,
- Patient with aortic root aneurysm and / or ascending aorta, or chronic Stanford A dissections whose surgical correction is restricted to the root, ascending aorta and extending distally up to the hemiarch , including reoperations,
- All procedures on the aortic valve and coronary ostia are allowed,
- All patients will be clarified on the details of the study and if they agree to participate, they will sign the informed consent form.
Who cannot join
- Patients with acute aortic dissection,
- Patients whose correction includes total replacement of the aortic arch or distal extension to it,
- Patients who require associated procedures on the other cardiac valves other than the aortic valve,
- Patients who require myocardial revascularization,
- Patients who refuse to receive blood products,
- Patients with chronic anemia (hemoglobin less than 12g / dl for women and 13g / dl for men),
Show all 10Show fewer
- Platelet count less than 150,000 / mm3,
- Coagulopathy (previous history, use of anticoagulants not reversed, prothrombin time higher than 14.8 seconds or INR (international normalized ratio) higher than 1.2), hypofibrinogenemia (fibrinogen less than or equal to 150mg / dl),
- Patients in uninterrupted use of antiplatelet therapy (less than 7 days of operation), inhibitors of glycoproteins IIb / IIIa, as well as some supplements or vitamins (ginger, ginkgo biloba or fish oil),
- Patients with terminal liver disease, renal dialysis and neoplasias.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute (InCor) University of Sao Paulo
São Paulo, 05403000
Ricardo R Dias, MD, PhD, 551126615075, ricardo.dias@incor.usp.br
Felix José A Ramires, MD, PhD, 551126615057, felix.ramires@incor.usp.br
About this study
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.
Read the 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.
- Being tested
- TDM-621
- Keywords
- Ascending Aortic Surgery, Hemostasis, Ascending Aortic Dissection, Ascending Aorta Aneurysm, Bleeding
- Medical subject headings
- Dissection, Ascending Aorta, Aneurysm, Ascending Aorta, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDM-621Combination product
Also called PuraStat®
The TDM-621 is a topic hemostatic product which will be used during ascending aortic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques. |
| TDM-621 | Active comparator | 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. Receives: Combination Product: TDM-621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the total bleeding up to 48 hours of the operation.
This evaluation will be made by measuring the wet weight of the compresses after infusion of protamine until the closure of the chest, also by measuring the volume of red cells recovered by the cell saver and through the flow of the mediastinum drain in the first 6hours, 12hours, 24hours and 48hours of the postoperative period initiated after the sternum closure.
Measured: Total blood volume measured up to 48hours after surgery.
Evaluate the number of bags of red blood cells transfused up to 48 hours of the operation.
This outcome will be evaluated by quantifying the number of bags of red blood cells needed, following the study criteria, during the operation until 48 hours after the postoperative period.
Measured: Total amount of red cells bags up to 48hours postoperative period.
Secondary outcomes (5)
To evaluate the transfusion of platelet concentrate, or cryoprecipitates or fresh frozen plasma received intraoperatively up to 48 hours after the end of the procedure.
Number of bags transfusion of platelet concentrate,or cryoprecipitates or fresh frozen plasma, received intraoperatively up to 48 hours after the end of the procedure.
Measured: Total number of bags of any component from intraoperative up to 48hours postoperative period.
Evaluation of postoperative complications.
Surgical wound infection, mediastinitis, pulmonary infection, sepsis, low cardiac output, adult respiratory distress syndrome, acute renal failure, renal dialysis, postoperative cerebrovascular accident, convulsive crisis, delirium, deep vein thrombosis, pulmonary thromboembolism, postoperative acute myocardial infarction, atrial and ventricular arrhythmias, until the day of hospital discharge.
Measured: From the postoperative time until the date of first documented event or date of hospital discharge whichever came first up to 2 weeks.
In hospital mortality
In hospital mortality
Measured: From the postoperative time until the date of death from any cause or date of hospital discharge whichever came first up to 2 weeks.
Evaluation of postoperative complications.
Body temperature higher or equal 37.8 °C in the first 72 hours postoperative (with or without antibiotic therapy), temperature higher than or equal to 37.8 ° C after 72 hours postoperative (with or without antibiotic therapy).
Measured: From the postoperative time up to 72 hours and after 72 hours up to hospital discharge.
Evaluation of postoperative complications.
The use of vasopressors in the first 48 hours postoperatively (noradrenaline and / or vasopressin).
Measured: From the postoperative time up to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start4 Dec 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ascending Aorta AbnormalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 3-D Matrix UK Ltd., InCor Heart Institute
- Responsible party
- Principal investigator, Ricardo Ribeiro Dias, University of Sao Paulo General Hospital
- Investigators
- Ricardo R Dias, MD,PhD, Study chair, Instituto do Coração - INCORHCFMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917862
- Sponsor's protocol ID
- 93960818.9.1001.0068
- Acronym
- SASH
- Status last verified
- Apr 2019
- First submitted
- 5 Feb 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not yet decided with executive committee how and what to share IPD (individual participant data).
Publications
Bhamidipati CM, Coselli JS, LeMaire SA. BioGlue in 2011: what is its role in cardiac surgery? J Extra Corpor Technol. 2012 Mar;44(1):P6-12.
PubMed 22730865Vyas KS, Saha SP. Comparison of hemostatic agents used in vascular surgery. Expert Opin Biol Ther. 2013 Dec;13(12):1663-72. doi: 10.1517/14712598.2013.848193. Epub 2013 Oct 22.
PubMed 24144261American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology. 2015 Feb;122(2):241-75. doi: 10.1097/ALN.0000000000000463. No abstract available.
PubMed 25545654Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.
PubMed 20940381Pagano D, Milojevic M, Meesters MI, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Boer C. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):79-111. doi: 10.1093/ejcts/ezx325. No abstract available.
PubMed 29029100Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
PubMed 38695613
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hemostatic Potential of TDM-621 on Ascending Aortic Surgery
- ClinicalTrials.gov ID
- NCT03917862
- Acronym / sponsor ID
- SASH / 93960818.9.1001.0068
- Keywords
- Ascending Aortic Surgery, Hemostasis, Ascending Aortic Dissection, Ascending Aorta Aneurysm, Bleeding
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- 3-D Matrix UK Ltd., InCor Heart Institute
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This group include patients which will be undergone to conventional ascending aortic surgery, according to stablished techniques. |
| TDM-621 | Active comparator | Combination Product: TDM-621This 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be over 18 years old,
- Patient with aortic root aneurysm and / or ascending aorta, or chronic Stanford A dissections whose surgical correction is restricted to the root, ascending aorta and extending distally up to the hemiarch , including reoperations,
- All procedures on the aortic valve and coronary ostia are allowed,
- All patients will be clarified on the details of the study and if they agree to participate, they will sign the informed consent form.
Key exclusion criteria (10 listed)
- Patients with acute aortic dissection,
- Patients whose correction includes total replacement of the aortic arch or distal extension to it,
- Patients who require associated procedures on the other cardiac valves other than the aortic valve,
- Patients who require myocardial revascularization,
- Patients who refuse to receive blood products,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TDM-621Also: PuraStat®The TDM-621 is a topic hemostatic product which will be used during ascending aortic surgery. | Combination product | TDM-621 |
Primary outcome
Evaluate the total bleeding up to 48 hours of the operation.
Time frame: Total blood volume measured up to 48hours after surgery.
This evaluation will be made by measuring the wet weight of the compresses after infusion of protamine until the closure of the chest, also by measuring the volume of red cells recovered by the cell saver and through the flow of the mediastinum drain in the first 6hours, 12hours, 24hours and 48hours of the postoperative period initiated after the sternum closure.
Evaluate the number of bags of red blood cells transfused up to 48 hours of the operation.
Time frame: Total amount of red cells bags up to 48hours postoperative period.
This outcome will be evaluated by quantifying the number of bags of red blood cells needed, following the study criteria, during the operation until 48 hours after the postoperative period.
5 secondary outcomes
To evaluate the transfusion of platelet concentrate, or cryoprecipitates or fresh frozen plasma received intraoperatively up to 48 hours after the end of the procedure.
Time frame: Total number of bags of any component from intraoperative up to 48hours postoperative period.
Evaluation of postoperative complications.
Time frame: From the postoperative time until the date of first documented event or date of hospital discharge whichever came first up to 2 weeks.
In hospital mortality
Time frame: From the postoperative time until the date of death from any cause or date of hospital discharge whichever came first up to 2 weeks.
Evaluation of postoperative complications.
Time frame: From the postoperative time up to 72 hours and after 72 hours up to hospital discharge.
Evaluation of postoperative complications.
Time frame: From the postoperative time up to 48 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 22730865Bhamidipati CM, Coselli JS, LeMaire SA. BioGlue in 2011: what is its role in cardiac surgery? J Extra Corpor Technol. 2012 Mar;44(1):P6-12.
- Background: PubMed 24144261Vyas KS, Saha SP. Comparison of hemostatic agents used in vascular surgery. Expert Opin Biol Ther. 2013 Dec;13(12):1663-72. doi: 10.1517/14712598.2013.848193. Epub 2013 Oct 22.
- Background: PubMed 25545654American Society of Anesthesiologists Task Force on Perioperative Blood Management. Practice guidelines for perioperative blood management: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Blood Management*. Anesthesiology. 2015 Feb;122(2):241-75. doi: 10.1097/ALN.0000000000000463. No abstract available.
- Background: PubMed 20940381Hajjar LA, Vincent JL, Galas FR, Nakamura RE, Silva CM, Santos MH, Fukushima J, Kalil Filho R, Sierra DB, Lopes NH, Mauad T, Roquim AC, Sundin MR, Leao WC, Almeida JP, Pomerantzeff PM, Dallan LO, Jatene FB, Stolf NA, Auler JO Jr. Transfusion requirements after cardiac surgery: the TRACS randomized controlled trial. JAMA. 2010 Oct 13;304(14):1559-67. doi: 10.1001/jama.2010.1446.
- Background: PubMed 29029100Pagano D, Milojevic M, Meesters MI, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Boer C. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. Eur J Cardiothorac Surg. 2018 Jan 1;53(1):79-111. doi: 10.1093/ejcts/ezx325. No abstract available.
- Derived from this study: PubMed 38695613Ma GW, Kucey A, Tyagi SC, Papia G, Kucey DS, Varcoe RL, Forbes T, Neville R, Dueck AD, Kayssi A. The role of sealants for achieving anastomotic hemostasis in vascular surgery. Cochrane Database Syst Rev. 2024 May 2;5(5):CD013421. doi: 10.1002/14651858.CD013421.pub2.
- Individual participant dataSharing planned: No. It is not yet decided with executive committee how and what to share IPD (individual participant data).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo R Dias, MD,PhD study chair
Instituto do Coração - INCORHCFMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TDM-621 in people with Ascending Aorta Abnormality and Ascending Aortic Dissection, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo R Dias, MD,PhD (551126615075, ricardo.dias@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the total bleeding up to 48 hours of the operation. (time frame: Total blood volume measured up to 48hours after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917862, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.