Hemostasis
Conditions
Keywords
tranexamic acid, cardiac surgery procedures, hemostasis
Brief 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. 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.
Interventions
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
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of exposure to allogeneic erythrocytes transfusions | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate and volume of fresh frozen plasma transfusion | Perioperatively | — |
| Rate and volume of allogeneic platelet transfusion | Perioperatively | — |
| Rate of reexploration for hemostasis | Perioperatively | — |
| Postoperative blood loss | Postoperatively | Defined as total volume of chest drainage postoperatively |
| Volume of allogeneic erythrocytes transfusions | 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). |
| Coagulatory and fibrinolytic associated moleculars | Perioperatively | FIB, FDP, FXI:C, AT-III, D-dimer and TXB2 |
| Inflammation associated moleculars | Perioperatively | ET-1, IL-2, IL-6, IL-8, IL-10, TNF-α, NE, FN and PGI2 |
| Length of stay in ICU and hospital postoperatively | Postoperatively | — |
| Thromboelastography | Perioperatively | — |
Countries
China
Contacts
Primary ContactLihuan Li, MD
Backup ContactJia Shi, MD
Outcome results
None listed