HemostasisNCT01060189
Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery
A study testing Ulinastatin, 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
Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemostasis
- What is being tested?
- Ulinastatin, Tranexamic Acid and Saline Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to Jan 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
- Atrial or ventricular septum defect patients requiring cardiac surgery with CPB
- Rheumatic or recessive valvular patients requiring valvular repair or replacement with CPB
- Coronary artery disease patients requiring coronary revascularization surgery with CPB
Who cannot join
- Non-primary cardiac surgery
- Definite liver or renal dysfunction
- Disorder in coagulation function
- 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
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, 100037
About this study
Official title: Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study
Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients undergoing CABG. After the secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin, urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in cardiac surgery.
- Conditions
- Hemostasis
- Being tested
- Ulinastatin, Tranexamic Acid, Saline Solution
- Keywords
- ulinastatin, 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.
UlinastatinDrug
Tranexamic AcidDrug
Saline SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Ulinastatin | Experimental | 1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization Receives: Drug: Ulinastatin |
| Tranexamic Acid | Experimental | 15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization Receives: Drug: Tranexamic Acid |
| Placebo | Placebo comparator | 50ml saline solution before skin incision; 50ml saline solution after neutralization Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative blood loss
Defined as the total volume of chest drainage postoperatively
Measured: Postoperatively
Secondary outcomes (6)
Rate of reexploration for bleeding
Measured: Postoperatively
Rate of major bleeding
Major bleeding is defined according to the CURE study
Measured: Perioperatively
Transfusion of allogeneic erythrocytes
Rate of exposure and volume of allogeneic erythrocytes transfused
Measured: Perioperatively
Transfusion of fresh frozen plasma (FFP)
Rate of exposure and volume of FFP transfused
Measured: Perioperatively
Transfusion of allogeneic platelets
Rate of exposure and volume of allogeneic platelets transfused
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 startApr 2008
- Primary completionJan 2009
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 426 participants (actual)
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
- NCT01060189
- Sponsor's protocol ID
- UTI Pilot Study
- Status last verified
- Feb 2019
- First submitted
- 28 Jan 2010
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang P, Lv H, Qi X, Xiao W, Xue Q, Zhang L, Li L, Shi J. Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up. J Cardiothorac Surg. 2020 May 14;15(1):98. doi: 10.1186/s13019-020-01144-9.
PubMed 32410683
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
- Hemostatic Effects of Ulinastatin and Tranexamic Acid in Cardiac Surgery With Cardiopulmonary Bypass: A Pilot Study
- ClinicalTrials.gov ID
- NCT01060189
- Acronym / sponsor ID
- UTI Pilot Study
- Conditions
- Hemostasis
- Keywords
- ulinastatin, tranexamic acid, cardiac surgery procedures, hemostasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Apr 2008 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2019 (actual)
- 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.
Antifibrinolytic drugs are used to decrease perioperative bleeding and allogeneic transfusions. The extensively studied antifibrinolytic drug aprotinin is efficacious but expensive, and has been proved to link to higher risks of serious side effects including renal problems, myocardial events, and strokes in patients undergoing CABG. After the secession of aprotinin in 2007, a marked increase of blood loss and transfusions in cardiac surgery took place. An effective and secure hemostatic agent is badly needed. Ulinastatin, urinary trypsin inhibitor(UTI), is a secreted Kunitz-type protease inhibitor with a wide inhibition spectrum, including plasmin. Limited studies offered clues to its antifibrinolytic effect. Tranexamic acid has been applied for years with convinced efficacy and safety. The objective of the study is to evaluate the hemostatic effect of ulinastatin and tranexamic acid in cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ulinastatin | Experimental | Drug: Ulinastatin1,000,000 units of ulinastatin in 50ml solution before skin incision; 50ml saline solution after neutralization |
| Tranexamic Acid | Experimental | Drug: Tranexamic Acid15mg/kg tranexamic acid in 50ml solution before skin incision; 15mg/kg tranexamic acid in 50ml solution after neutralization |
| Placebo | Placebo comparator | Drug: Saline Solution50ml saline solution before skin incision; 50ml saline solution after neutralization |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Atrial or ventricular septum defect patients requiring cardiac surgery with CPB
- Rheumatic or recessive valvular patients requiring valvular repair or replacement with CPB
- Coronary artery disease patients requiring coronary revascularization surgery with CPB
Key exclusion criteria (7 listed)
- Non-primary cardiac surgery
- Definite liver or renal dysfunction
- Disorder in coagulation function
- 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 |
|---|---|---|
| Ulinastatin | Drug | Ulinastatin |
| Tranexamic Acid | Drug | Tranexamic Acid |
| Saline Solution | Drug | Placebo |
Primary outcome
Postoperative blood loss
Time frame: Postoperatively
Defined as the total volume of chest drainage postoperatively
6 secondary outcomes
Rate of reexploration for bleeding
Time frame: Postoperatively
Rate of major bleeding
Time frame: Perioperatively
Transfusion of allogeneic erythrocytes
Time frame: Perioperatively
Transfusion of fresh frozen plasma (FFP)
Time frame: Perioperatively
Transfusion of allogeneic platelets
Time frame: Perioperatively
Length of stay in ICU and hospital postoperatively
Time frame: Postoperatively
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 5 Feb 2019.
- Derived from this study: PubMed 32410683Zhang P, Lv H, Qi X, Xiao W, Xue Q, Zhang L, Li L, Shi J. Effect of ulinastatin on post-operative blood loss and allogeneic transfusion in patients receiving cardiac surgery with cardiopulmonary bypass: a prospective randomized controlled study with 10-year follow-up. J Cardiothorac Surg. 2020 May 14;15(1):98. doi: 10.1186/s13019-020-01144-9.
Related trials for Hemostasis
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Not yet recruitingPhase 1
Topical TOR-582 Treatment of Epistaxis in HHT
Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
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 Ulinastatin, 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: finished, 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?
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?
Postoperative blood loss (time frame: Postoperatively). 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 NCT01060189, which also lists 1 linked publication.
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.