Thromboses, Deep VeinPhase 4NCT03838328
Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery
A Phase 4 study testing Tranexamic Acid in people with Thromboses, Deep Vein and Tranexamic Acid Adverse Reaction, run by SHI Jia at 1 site in China.
Trial summary
In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thromboses, Deep Vein, Tranexamic Acid Adverse Reaction
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Mar 2020
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- Written consent obtained
Who cannot join
- Allergy or contraindication to tranexamic acid
- Severe renal impairment (serum creatinine >250 μmol/l, or estimated creatinine clearance <25 ml/min)
- Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
- Thrombocytopenia defined as a platelet count <100,000/ml
- Coagulopathy defined as an international normalized ratio > 1.5 prior to surgery
- Currently enrolled in another perioperative interventional study
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass
In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.
- Being tested
- Tranexamic Acid
- Keywords
- dose effect, tranexamic acid, deep vein thromboses
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
| Study group | Role | What they receive |
|---|---|---|
| Dose group 1 | Experimental | The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation. Receives: Drug: Tranexamic Acid |
| Dose group 2 | Experimental | The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation. Receives: Drug: Tranexamic Acid |
| Dose group 3 | Active comparator | The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of deep venous thrombosis
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
Measured: Within 7 days postoperatively
Secondary outcomes (4)
The rate of new-onset thrombotic events
Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism
Measured: Within 90 days postoperatively
The rate of allogeneic RBC transfusion
Allogeneic blood product includes packed red blood cell
Measured: Within 30 days postoperatively
The volume of allogeneic RBC transfusion
Allogeneic blood product includes packed red blood cell
Measured: Within 30 days postoperatively
Length of stay in ICU and hospital
The time interval between the end of the operation and the discharge from ICU or the hospital.
Measured: Within 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboses, Deep VeinStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SHI Jia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Jia Shi, M.D., Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838328
- Sponsor's protocol ID
- Dose effect of TA on DVT
- Status last verified
- Feb 2019
- First submitted
- 1 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03838328
- Acronym / sponsor ID
- Dose effect of TA on DVT
- Keywords
- dose effect, tranexamic acid, deep vein thromboses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- SHI JiaUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 12 Feb 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.
In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose group 1 | Experimental | Drug: Tranexamic AcidThe dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation. |
| Dose group 2 | Experimental | Drug: Tranexamic AcidThe dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation. |
| Dose group 3 | Active comparator | Drug: Tranexamic AcidThe dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
- Written consent obtained
Key exclusion criteria (7 listed)
- Allergy or contraindication to tranexamic acid
- Severe renal impairment (serum creatinine >250 μmol/l, or estimated creatinine clearance <25 ml/min)
- Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
- Thrombocytopenia defined as a platelet count <100,000/ml
- Coagulopathy defined as an international normalized ratio > 1.5 prior to surgery
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 |
|---|---|---|
| Tranexamic AcidTranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation. | Drug | Dose group 1, Dose group 2, Dose group 3 |
Primary outcome
The incidence of deep venous thrombosis
Time frame: Within 7 days postoperatively
Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound
4 secondary outcomes
The rate of new-onset thrombotic events
Time frame: Within 90 days postoperatively
The rate of allogeneic RBC transfusion
Time frame: Within 30 days postoperatively
The volume of allogeneic RBC transfusion
Time frame: Within 30 days postoperatively
Length of stay in ICU and hospital
Time frame: Within 90 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Thromboses, Deep Vein
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Active, not recruiting
This Research Proposal Focuses on Evaluating the Effectiveness of a Nursing Care Protocol in Preventing Deep Vein Thrombosis (DVT) in Patients Undergoing On-pump Cardiac Surgery. The Study Will Include an Intervention Group That Receives the Nursing Protocol and a Control Group That Receives Routine
On-pump Cardiac Surgery - Prevention - Intervention - Experimental Group - Control Group - Incidence - Complications, DVT - Deep Vein Thrombosis
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
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.
Jia Shi, M.D. principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid in people with Thromboses, Deep Vein and Tranexamic Acid Adverse Reaction, run by SHI Jia at 1 site in China.
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 2 inclusion and 7 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 12 Feb 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 China. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Jia Shi, M.D. (86 10 88322467, shiandypumc@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of deep venous thrombosis (time frame: Within 7 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2019.