Topical tranexamic acid in cardiac surgery patients

Conditions: post-operative blood loss
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-000774-30-NL

Lead Sponsor: Amphia Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Gender; male/ female
• Age: = 18 year
• Elective cardiac surgical patients
o CABG (conventional, E.CCO)
o AVR (conventional)
o MVP/MVR (conventional)
o TVP/ TPL
o Bentall
o Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/MAZE)
• Acute patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

• MVP/MVR (minimal invasive)
• Maze (minimal invasive)
• AVR (minimal invasive)
• off-pump procedures

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: the objective of this study is to determine whether the application of topical TA into the pericardial cavity just before sternal closure has an added value in the reduction of post-operative blood loss after cardiac surgery patients on CPB.;Secondary Objective: in addition, this study is designed to compare the amount of blood component transfusion (packed red blood cells, platelet concentrate, Octoplas®, haemocomplettan®, cofact®), routine coagulation tests variables (INR, aPTT, number of platelets, fibrinogen level, Hb/Ht), rotem® variables (CT InTEM, A10 intem, angle ExTEM, A10 FibTEM) and surgical re-explorations between the three groups.;Primary end point(s): The primary study parameter is post-operative blood loss and is assessed by post-operative chest tube production. ;Timepoint(s) of evaluation of this end point: post-operative chest tube production 12 hours after surgical procedure

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary study parameters which are assessed:<br>•total amount of blood component transfusion (until discharge ICU)<br>opacked red blood cells<br>ofibrinogen concentrates (haemocomplettan® CSL Behring)<br>oFFP (Octoplas®)<br>oPlatelet concentrate<br>oFactor II, VII, IX en X concentrates (Cofact®)<br>•Routine coagulation tests (one day before surgery, post-operative at arrival at ICU and one day after surgery)<br>oINR<br>oaPTT<br>onumber of platelets<br>ofibrinogen level<br>oHct/ Hb<br>•Rotem variables<br>oCt InTEM<br>oA10 InTEM<br>oAngle extem<br>oA10 FibTEM.<br>;Timepoint(s) of evaluation of this end point: preoperative one day<br>post-operative at arrival at ICU, one day, discharge IC