Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery

Blood Coagulation Disorders Clinical Trial

Official title:

Placebo-Controlled, Randomized, Double-Blind Trial of Prophylactic Desmopressin in Heart Valve Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03343418
• Other study ID #: 3962.13.087
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 10, 2017
• Last updated: November 16, 2017
• Start date: February 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Instituto do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• C.Surgical Procedure; Cardiac
• Hemostatic Disorders

Intervention

Drug:
• Desmopressin
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.
• Placebo
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.

Locations

Country	Name	City	State
Brazil	Incor - Heart Institute - University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Coracao

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Galas FR, de Almeida JP, Fukushima JT, Vincent JL, Osawa EA, Zeferino S, Câmara L, Guimarães 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in coagulation parameters	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 (a º), Maximum Clot Firmness (MCF) mm ] and platelets aggregation (%)	Coagulation parameters will be performed: T0: preoperative period; T1 - 2 hours after desmopressin or placebo administration; T2 - 24 hours after desmopressin or placebo administration
Primary	Postoperative blood loss	Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours	48 hours
Secondary	Blood transfusion	Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU	30 days
Secondary	Reoperation for bleeding		30 days
Secondary	Duration of Mechanical ventilation		30 days
Secondary	Length of vasoactive drugs		30 days
Secondary	Length of ICU stay		30 days
Secondary	Clinical complications - renal failure, infection, myocardial ischemia, stroke		30 days
Secondary	Length of hospital stay		30 days
Secondary	Mortality		30 days