Topical tranexamic acid in cardiac surgery patients

The effect on blood loss with combined topical and intravenous tranexamic acid in cardiac surgery patients: a randomized double-blind placebo-controlled trial - Topical tranexamic acid in cardiac surgery patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000774-30-NL

Enrollment

600

Registered

2013-03-20

Start date

2013-04-24

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-operative blood loss

Interventions

Trade Name: Cyklokapron Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: tranexamic acid Other descriptive name: TRANEXAMIC ACID Concentration unit: mg/ml mi

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): The secondary study parameters which are assessed: • total amount of blood component transfusion (until discharge ICU) o packed red blood cells o fibrinogen concentrates (haemocomplettan® CSL Behring) o FFP (Octoplas®) o Platelet concentrate o Factor II, VII, IX en X concentrates (Cofact®) • Routine coagulation tests (one day before surgery, post-operative at arrival at ICU and one day after surgery) o INR o aPTT o number of platelets o fibrinogen level o Hct/ Hb • Rotem variables o Ct InTEM o A10 InTEM o Angle extem o A10 FibTEM. ;Timepoint(s) of evaluation of this end point: preoperative one day post-operative at arrival at ICU, one day, discharge ICU	—

Measure

Time frame

Secondary end point(s): The secondary study parameters which are assessed: • total amount of blood component transfusion (until discharge ICU) o packed red blood cells o fibrinogen concentrates (haemocomplettan® CSL Behring) o FFP (Octoplas®) o Platelet concentrate o Factor II, VII, IX en X concentrates (Cofact®) • Routine coagulation tests (one day before surgery, post-operative at arrival at ICU and one day after surgery) o INR o aPTT o number of platelets o fibrinogen level o Hct/ Hb • Rotem variables o Ct InTEM o A10 InTEM o Angle extem o A10 FibTEM. ;Timepoint(s) of evaluation of this end point: preoperative one day post-operative at arrival at ICU, one day, discharge ICU

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Countries

Netherlands

Contacts

Public ContactClinical Trials Information

Amphia Hospital

bgerritse@amphia.nl0031765951508

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026