HemostasisNCT01060176
Three Dose Regimen of Tranexamic Acid in Cardiac Surgery
A study testing Tranexamic Acid and Saline Solution in people with Hemostasis, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemostasis
- What is being tested?
- Tranexamic Acid and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Feb 2010to Dec 2019
- Phase
- Interventional
- 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
- Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
- Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
- Wrriten consent obtained
Who cannot join
- Non-primary cardiac surgery
- Preoperative liver or renal dysfunction
- Preoperative coagulation disorder
- Allergy
- Pregnancy or lactation
- Disabled in spirit or law
- Fatal conditions such as tumour
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
Lihuan Li, MD, 86-10-88398184, llhfw@sina.com
Jia Shi, MD, 86-10-88322467, shiandypumc@sina.com
About this study
Official title: Three Dose Regimen of Tranexamic Acid on Blood Loss and Allogeneic Transfusions in Cardiac Surgery With Cardiopulmonary Bypass
Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.
- Conditions
- Hemostasis
- Being tested
- Tranexamic Acid, Saline Solution
- Keywords
- tranexamic acid, cardiac surgery procedures, hemostasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Saline SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| High dosage | Experimental | Tranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h Receives: Drug: Tranexamic Acid |
| Medium dosage | Experimental | Tranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h Receives: Drug: Tranexamic Acid |
| Low dosage | Experimental | Tranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h Receives: Drug: Tranexamic Acid |
| Control | Placebo comparator | Saline solution Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of exposure to allogeneic erythrocytes transfusions
Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (>70 years).
Measured: Perioperatively
Secondary outcomes (9)
Volume of allogeneic erythrocytes transfusions
Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (>70 years).
Measured: Perioperatively
Rate and volume of fresh frozen plasma transfusion
Measured: Perioperatively
Rate and volume of allogeneic platelet transfusion
Measured: Perioperatively
Rate of reexploration for hemostasis
Measured: Perioperatively
Postoperative blood loss
Defined as total volume of chest drainage postoperatively
Measured: Postoperatively
Thromboelastography
Measured: Perioperatively
Coagulatory and fibrinolytic associated moleculars
FIB, FDP, FXI:C, AT-III, D-dimer and TXB2
Measured: Perioperatively
Inflammation associated moleculars
ET-1, IL-2, IL-6, IL-8, IL-10, TNF-α, NE, FN and PGI2
Measured: Perioperatively
Length of stay in ICU and hospital postoperatively
Measured: Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Lihuan Li, MD, Study chair, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMCJia Shi, MD, Principal investigator, Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060176
- Sponsor's protocol ID
- TXA Dosage Trial
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2010
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dose Regimen of Tranexamic Acid on Blood Loss and Allogeneic Transfusions in Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT01060176
- Acronym / sponsor ID
- TXA Dosage Trial
- Conditions
- Hemostasis
- Keywords
- tranexamic acid, cardiac surgery procedures, hemostasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Feb 2010 (estimated)
- 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.
Tranexamic acid is thought to be a promising substitute for aprotinin when the latter has seceded in 2007. Yet the ideal dosage and dosing regimen of tranexamic acid in cardiopulmonary bypass cardiac surgery in Chinese population remains controversial. The current study includes patients receiving valvular replacement and coronary artery bypass surgery. Three dosage regimen of tranexamic acid is delivered and blood loss, transfusions and clinical outcomes are recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High dosage | Experimental | Drug: Tranexamic AcidTranexamic acid with a loading dose of 30 mg/kg and a maintenance infusion of 20 mg/kg/h |
| Medium dosage | Experimental | Drug: Tranexamic AcidTranexamic acid with a loading dose of 20 mg/kg and a maintenance infusion of 15 mg/kg/h |
| Low dosage | Experimental | Drug: Tranexamic AcidTranexamic acid with a loading dose of 10 mg/kg and a maintenance infusion of 10 mg/kg/h |
| Control | Placebo comparator | Drug: Saline SolutionSaline solution |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Rheumatic or recessive valvular disease patients requiring valvular replacement surgery with cardiopulmonary bypass
- Coronary artery disease patients requiring coronary artery bypass surgery with cardiopulmonary bypass
- Wrriten consent obtained
Key exclusion criteria (7 listed)
- Non-primary cardiac surgery
- Preoperative liver or renal dysfunction
- Preoperative coagulation disorder
- Allergy
- Pregnancy or lactation
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 Acid | Drug | High dosage, Low dosage, Medium dosage |
| Saline Solution | Drug | Control |
Primary outcome
Rate of exposure to allogeneic erythrocytes transfusions
Time frame: Perioperatively
Allogeneic RBCs were transfused if the hemoglobin level was less than 6 g/dL during cardiopulmonary bypass, less than 8 g/dL postoperatively, or less than 9 g/dL for elderly people (>70 years).
9 secondary outcomes
Volume of allogeneic erythrocytes transfusions
Time frame: Perioperatively
Rate and volume of fresh frozen plasma transfusion
Time frame: Perioperatively
Rate and volume of allogeneic platelet transfusion
Time frame: Perioperatively
Rate of reexploration for hemostasis
Time frame: Perioperatively
Postoperative blood loss
Time frame: Postoperatively
Thromboelastography
Time frame: Perioperatively
Coagulatory and fibrinolytic associated moleculars
Time frame: Perioperatively
Inflammation associated moleculars
Time frame: Perioperatively
Length of stay in ICU and hospital postoperatively
Time frame: Postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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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.
Lihuan Li, MD study chair
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Jia Shi, MD principal investigator
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and Saline Solution in people with Hemostasis, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 3 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 5 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Lihuan Li, MD (86-10-88398184, llhfw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of exposure to allogeneic erythrocytes transfusions (time frame: Perioperatively). 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 5 Feb 2019.