Blood Coagulation Disorders Clinical Trial
Official title:
Placebo-Controlled, Randomized, Double-Blind Trial of Prophylactic Desmopressin in Heart Valve Surgery
Verified date | November 2017 |
Source | Instituto do Coracao |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Brazil | Incor - Heart Institute - University of Sao Paulo | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Instituto do Coracao |
Brazil,
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
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 ยบ), 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 |
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