Outcome Impact of Different Tranexamic Acid Regimen in Cardiac Surgery With Cardiopulmonary Bypass
Paraules clau
Resum
Descripció
A face to face visit (review in hospital, or remote video interview via smart phone and social media) is required to screen the occurrence of 30-day rate of the composite endpoints of renal dysfunction, myocardial infarction,stroke, seizure, deep venous thrombosis, pulmonary embolism and all-cause mortality, specific examinations are needed to confirm the diagnosis.
Dates
Darrera verificació: | 04/30/2020 |
Primer enviat: | 12/16/2018 |
Inscripció estimada enviada: | 12/17/2018 |
Publicat per primera vegada: | 12/19/2018 |
Última actualització enviada: | 05/09/2020 |
Publicació de l'última actualització: | 05/11/2020 |
Data d'inici de l'estudi real: | 12/25/2018 |
Data estimada de finalització primària: | 12/30/2020 |
Data estimada de finalització de l’estudi: | 12/30/2021 |
Condició o malaltia
Intervenció / tractament
Drug: Tranexamic Acid Dosage 1
Drug: Tranexamic Acid Dosage 2
Fase
Grups de braços
Braç | Intervenció / tractament |
---|---|
Experimental: Tranexamic Acid Dosage 1 A bolus of 30 mg/kg Tranexamic Acid for 20 min followed by a maintenance dose of 16 mg/kg/h Tranexamic Acid until the end of surgery, and a pump prime dose 2 mg/kg. | Drug: Tranexamic Acid Dosage 1 Tranexamic Acid Dosage 1 |
Active Comparator: Tranexamic Acid Dosage 2 A bolus of 10 mg/kg Tranexamic Acid for 20 min followed by a maintenance dose of 2 mg/kg/h Tranexamic Acid until the end of surgery, and a pump prime dose 1 mg/kg. | Drug: Tranexamic Acid Dosage 2 Tranexamic Acid Dosage 2 |
Criteris d'elegibilitat
Edats elegibles per estudiar | 18 Years Per a 18 Years |
Sexes elegibles per estudiar | All |
Accepta voluntaris saludables | Sí |
Criteris | Inclusion Criteria: 1. Male or female adult patients aged 18~70 years. 2. Patients receiving cardiac surgery with cardiopulmonary bypass 3. Written Informed consent obtained Exclusion Criteria: 1. Acquired chromatic disorder 2. Active intravascular coagulation 3. Previous convulsion or seizure 4. Allergy or contraindication to tranexamic acid injection or its components 5. Feeding or pregnancy women 6. Terminal illness with a life expectancy of less than 3 months 7. Patients with mental or legal disability 8. Currently enrolled in another perioperative interventional study |
Resultat
Mesures de resultats primaris
1. Perioperative allogeneic RBC transfusion rate [From the operation day to the discharge, an average of 7 days]
2. Composite rate of renal dysfunction, myocardial infarction,stroke, seizure, deep venous thrombosis, pulmonary embolism and all-cause mortality [30-day postoperatively]
Mesures de resultats secundaris
1. Perioperative allogeneic RBC transfusion volume [From the operation day to the discharge, an average of 7 days]
2. Perioperative allogeneic non-RBC transfusion volume [From the operation day to the discharge, an average of 7 days]
3. Perioperative allogeneic non-RBC transfusion rate [From the operation day to the discharge, an average of 7 days]
4. Postoperative bleeding volume [From the operation day to the discharge, an average of 7 days]
5. Reoperation rate for bleeding [From the operation day to the discharge, an average of 7 days]
6. The duration of mechanical ventilation [from the end of the operation and the extubation, an average of 24 hours]
7. Length of stay in the intensive care unit [From the end of the operation and the discharge from the intensive care unit, an average of 48 hours]
8. Length of stay in hospital [From the operation day to the discharge, an average of 7 days]
9. Total hospitalization cost [In hospital, an average of 7 days]
Altres mesures de resultats
1. Thrombotic test [preoperative、4~8 hours postoperative、1st postoperative day、2nd postoperative day、3rd postoperative day]
2. Correction Dimension of Electroencephalogram [12 hours postoperatively]
3. Bispectral Index [From anesthetic induction until 12 hours postoperatively, an average of 18 hours]
4. Drug concentration in plasma and cerebrospinal fluid [Fourteen timepoints from anesthetic induction until 6 hours postoperatively]