Clinical trial NCT03343418: Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery
Official title: Placebo-Controlled, Randomized, Double-Blind Trial of Prophylactic Desmopressin in Heart Valve Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: C.Surgical Procedure; Cardiac
Blood Coagulation Disorders
Keywords: Bleeding
Valve Cardiac Surgery
Desmopressin
Lead sponsor: Instituto do Coracao
Sponsor class: OTHER_GOV
First posted: 2017-11-17
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in coagulation parameters
timeFrame: Coagulation parameters will be performed: T0: preoperative period; T1 - 2 hours after desmopressin or placebo administration; T2 - 24 hours after desmopressin or placebo administration
measure: Postoperative blood loss
timeFrame: 48 hours
Secondary outcomes:
measure: Blood transfusion
timeFrame: 30 days
measure: Reoperation for bleeding
timeFrame: 30 days
measure: Duration of Mechanical ventilation
timeFrame: 30 days
measure: Length of vasoactive drugs
timeFrame: 30 days
measure: Length of ICU stay
timeFrame: 30 days
measure: Clinical complications - renal failure, infection, myocardial ischemia, stroke
timeFrame: 30 days
measure: Length of hospital stay
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Incor - Heart Institute - University of Sao Paulo
Study officials:
References:
citation: Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Camara L, Guimaraes VA, Jatene MB, Hajjar LA. Hemostatic effects of fibrinogen concentrate compared with cryoprecipitate in children after cardiac surgery: a randomized pilot trial. J Thorac Cardiovasc Surg. 2014 Oct;148(4):1647-55. doi: 10.1016/j.jtcvs.2014.04.029. Epub 2014 Apr 18.