Blood Coagulation Disorders, C.Surgical Procedure; Cardiac
Conditions
Keywords
Bleeding, Valve Cardiac Surgery, Desmopressin
Brief summary
The purpose of this study is evaluate the effect of prophylactic desmopressin on blood coagulation parameters and postoperative bleeding in patients undergoing valve cardiac surgery with cardiopulmonary bypass.
Detailed description
Patients with important valve disorders may evaluate with coagulopathy induced by mechanical effects (valvular stenosis or valvular insufficiency). Furthermore, frequently is required prophylactic use of antiplatelet drugs due to myocardial remodeling and antiarrhythmic conditions that may be associated. Patients with severe aortic stenosis may also acquired von Willebrand disease type 2A due to proteolysis of vonWillebrand factor. Despite of this, the treatment of valve disorders often requires cardiac surgery with cardiopulmonary bypass. On average 50 to 60% of patients undergoing cardiac surgery receive blood tranfusions. Blood cell transfusion is an independent risk factor for increased morbidity and mortality in critically ill patients. The use of desmopressin seems beneficial only in patients with congenital or acquired platelet dysfunction. In general population, such use is not validated due to inconclusive results of researches.
Interventions
DRUGDesmopressin
Desmopressin is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given desmopressin 0,3 microgram.kg-1. After desmopressin infusion, bleeding treatment will follow the predefined standardized treatment regimen.
DRUGPlacebo
0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 100 milliliters (mL) 0.9% saline (SF0,9%). After 0.9% saline infusion, bleeding treatment will follow the predefined standardized treatment regimen.
Sponsors
Instituto do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Valve cardiac surgery with cardiopulmonary bypass. * Written informed consent
Exclusion criteria
* Reoperative valve surgery * Hematocrit \< 35% * Ventricular dysfunction (EF \< 40%) * Infection * Body mass index \> 35 * Renal impairment (Creatinin \> 2mg/dL) * Antiplatelet administration within 10 days preceding study surgery * Participation in another interventional clinical study within 30 days * Known or suspected hypersensitivity to the desmopressin * Coagulopathy (INR \> 1.5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in coagulation parameters | Coagulation parameters will be performed: T0: preoperative period; T1 - 2 hours after desmopressin or placebo administration; T2 - 24 hours after desmopressin or placebo administration | Laboratory variables: Activated partial thromboplastin time \[(aPTT) seconds\], prothrombin time \[(PT) seconds\], haematocrit (%), haemoglobin(g/dl), fibrinogen(mg/dL), D dimer (ng/L), factor VIII(%), Von Willebrand factor(%), ROTEM \[(INTEM, EXTEM, FIBTEM) Clotting Time (CT) and Clot Formation Time (CFT) seconds, alpha angle (α º), Maximum Clot Firmness (MCF) mm \] and platelets aggregation (%) |
| Postoperative blood loss | 48 hours | Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood transfusion | 30 days | Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU |
| Reoperation for bleeding | 30 days | — |
| Duration of Mechanical ventilation | 30 days | — |
| Length of vasoactive drugs | 30 days | — |
| Length of ICU stay | 30 days | — |
| Clinical complications - renal failure, infection, myocardial ischemia, stroke | 30 days | — |
| Length of hospital stay | 30 days | — |
| Mortality | 30 days | — |
Countries
Brazil
Outcome results
None listed