Effects of Prophylactic Desmopressin on Blood Coagulation Parameters in Heart Valve Surgery
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|ClinicalTrials.gov Identifier: NCT03343418|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|C.Surgical Procedure; Cardiac Blood Coagulation Disorders||Drug: Desmopressin Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Placebo-Controlled, Randomized, Double-Blind Trial of Prophylactic Desmopressin in Heart Valve Surgery|
|Study Start Date :||February 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
Active Comparator: desmopressin
Patients randomized to this group receive desmopressin 0,3 microgram.kg-1 as an intravenous infusion given during 20 min.
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 Comparator: Placebo
Patients randomized to the control group will receive the infusion of 100 mL 0.9% saline (SF0,9%).
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.
- Change in coagulation parameters [ Time Frame: 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 [ Time Frame: 48 hours ]Total chest tube drainage (mL) starting immediately after closure of the chest in the operating theater until 48 hours
- Blood transfusion [ Time Frame: 30 days ]Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU
- Reoperation for bleeding [ Time Frame: 30 days ]
- Duration of Mechanical ventilation [ Time Frame: 30 days ]
- Length of vasoactive drugs [ Time Frame: 30 days ]
- Length of ICU stay [ Time Frame: 30 days ]
- Clinical complications - renal failure, infection, myocardial ischemia, stroke [ Time Frame: 30 days ]
- Length of hospital stay [ Time Frame: 30 days ]
- Mortality [ Time Frame: 30 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343418
|Incor - Heart Institute - University of Sao Paulo|
|Sao Paulo, Brazil, 05403000|