HemorrhageNCT01191554
Dose-ranging Study of Tranexamic Acid in Valve Surgery
A study testing Tranexamic Acid in people with Hemorrhage and Valvular Heart Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhage, Valvular Heart Surgery
- 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
- 175 participants
- Where
- 1 siteChina
- Study dates
- Sep 2010to Oct 2011
- 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
- valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)
Who cannot join
- a history of bleeding disorders
- active chronic hepatitis or cirrhosis
- chronic renal insufficiency (serum creatinine > 2 mg/dl)
- preoperative anemia (Hb < 10 g/dl)
- previous cardiac surgery
- urgent and emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.
- Conditions
- Hemorrhage, Valvular Heart Surgery
- Being tested
- Tranexamic Acid
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
High and low dosage. Loading dose followed by continuous infusion in operation.
| Study group | Role | What they receive |
|---|---|---|
| High dosage | Experimental | A loading dose of 30 mg/kg and a maintenance infusion of 16 mg/kg through out the operation, and 2 mg/kg into the cardiopulmonary bypass (CPB) prime volume. Receives: Drug: Tranexamic Acid |
| Low dosage | Experimental | A loading dose of 10 mg/kg and a maintenance infusion of 1 mg/kg through out the operation, and 1 mg/kg into the cardiopulmonary bypass (CPB) prime volume. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of allogeneic red blood cells transfused
Measured: 7 days post-operation
Secondary outcomes (2)
Chest tube drainage
Measured: 6 hours post-operation
Chest tube drainage
Measured: 24 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Lihuan Li, M.D, Study chair, Fuwai Hospital & Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191554
- Sponsor's protocol ID
- FW2009006
- Status last verified
- Nov 2012
- First submitted
- 30 Aug 2010
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Tranexamic Acid Dose Regimens on Postoperative Bleeding and Transfusion Needs in Primary Valve Surgery
- ClinicalTrials.gov ID
- NCT01191554
- Acronym / sponsor ID
- FW2009006
- Conditions
- Hemorrhage, Valvular Heart Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 31 Aug 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.
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Tranexamic acid (TA), a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with Cardiopulmonary bypass. There are currently multiple dosing regimens for TA in cardiac surgery. Preliminary dose-response study has shown that low dose of TA would be as hemostatic efficacy as higher dose. Currently, no randomized study focus on TA in primary valve surgery. The aim of this prospective, double-blinded, randomized trial is to compare two dosing regimens of TA during primary valve surgery on perioperative blood loss and allogeneic blood transfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dosage | Experimental | Drug: Tranexamic AcidA loading dose of 30 mg/kg and a maintenance infusion of 16 mg/kg through out the operation, and 2 mg/kg into the cardiopulmonary bypass (CPB) prime volume. |
| Low dosage | Experimental | Drug: Tranexamic AcidA loading dose of 10 mg/kg and a maintenance infusion of 1 mg/kg through out the operation, and 1 mg/kg into the cardiopulmonary bypass (CPB) prime volume. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass (CPB)
Key exclusion criteria (6 listed)
- a history of bleeding disorders
- active chronic hepatitis or cirrhosis
- chronic renal insufficiency (serum creatinine > 2 mg/dl)
- preoperative anemia (Hb < 10 g/dl)
- previous cardiac 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 AcidHigh and low dosage. Loading dose followed by continuous infusion in operation. | Drug | High dosage, Low dosage |
Primary outcome
Frequency of allogeneic red blood cells transfused
Time frame: 7 days post-operation
2 secondary outcomes
Chest tube drainage
Time frame: 6 hours post-operation
Chest tube drainage
Time frame: 24 hours post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
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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, M.D study chair
Fuwai Hospital & Cardiovascular Institute
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 in people with Hemorrhage and Valvular Heart Surgery, 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 6 Nov 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of allogeneic red blood cells transfused (time frame: 7 days post-operation). 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 6 Nov 2012.