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Trial record 58 of 199 for:    Protamine

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
Sponsor:
Information provided by (Responsible Party):
Filomena R B G Galas, Instituto do Coracao

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.

Condition or disease Intervention/treatment Phase
C.Surgical Procedure; Cardiac Blood Coagulation Disorders Drug: Desmopressin Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

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Arm Intervention/treatment
Active Comparator: desmopressin
Patients randomized to this group receive desmopressin 0,3 microgram.kg-1 as an intravenous infusion given during 20 min.
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 Comparator: Placebo
Patients randomized to the control group will receive the infusion of 100 mL 0.9% saline (SF0,9%).
Drug: 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.




Primary Outcome Measures :
  1. 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 (%)

  2. 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


Secondary Outcome Measures :
  1. Blood transfusion [ Time Frame: 30 days ]
    Number of units of red blood cells, fresh frozen plasma,platelets, cryoprecipitate in the operating theater and ICU

  2. Reoperation for bleeding [ Time Frame: 30 days ]
  3. Duration of Mechanical ventilation [ Time Frame: 30 days ]
  4. Length of vasoactive drugs [ Time Frame: 30 days ]
  5. Length of ICU stay [ Time Frame: 30 days ]
  6. Clinical complications - renal failure, infection, myocardial ischemia, stroke [ Time Frame: 30 days ]
  7. Length of hospital stay [ Time Frame: 30 days ]
  8. Mortality [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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Brazil
Incor - Heart Institute - University of Sao Paulo
Sao Paulo, Brazil, 05403000
Sponsors and Collaborators
Instituto do Coracao

Publications:
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Responsible Party: Filomena R B G Galas, Associate Professor, Instituto do Coracao
ClinicalTrials.gov Identifier: NCT03343418     History of Changes
Other Study ID Numbers: 3962.13.087
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Keywords provided by Filomena R B G Galas, Instituto do Coracao:
Bleeding
Valve Cardiac Surgery
Desmopressin
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs