Hemostasis
Conditions
Keywords
ulinastatin, tranexamic acid, cardiac surgery procedures, hemostasis
Brief 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 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.
Interventions
DRUGUlinastatin
DRUGTranexamic Acid
DRUGSaline Solution
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative blood loss | Postoperatively | Defined as the total volume of chest drainage postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of major bleeding | Perioperatively | Major bleeding is defined according to the CURE study |
| Transfusion of allogeneic erythrocytes | Perioperatively | Rate of exposure and volume of allogeneic erythrocytes transfused |
| Rate of reexploration for bleeding | Postoperatively | — |
| Transfusion of allogeneic platelets | Perioperatively | Rate of exposure and volume of allogeneic platelets transfused |
| Length of stay in ICU and hospital postoperatively | Postoperatively | — |
| Transfusion of fresh frozen plasma (FFP) | Perioperatively | Rate of exposure and volume of FFP transfused |
Countries
China
Outcome results
None listed