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The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients

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ClinicalTrials.gov Identifier: NCT01895101
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : April 10, 2015
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Thierry V Scohy, Amphia Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Blood Loss
Tranexamic Acid
Cardiac Surgery
Interventions Drug: 2 gr tranexamic acid
Drug: Saline
Enrollment 750
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline
Hide Arm/Group Description

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.

Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

In this arm the subjects receives as in standard care no pericardial lavage.

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Period Title: Overall Study
Started 250 250 250
Completed 249 245 245
Not Completed 1 5 5
Reason Not Completed
OPCAB procedure             1             1             3
Withdrawal by Subject             0             1             2
another study, enrolled in other study             0             1             0
Death             0             1             0
coagulation disorder             0             1             0
Arm/Group Title Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline Total
Hide Arm/Group Description

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.

Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

In this arm the subjects receives as in standard care no pericardial lavage.

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Total of all reporting groups
Overall Number of Baseline Participants 249 245 245 739
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 249 participants 245 participants 245 participants 739 participants
68
(62 to 75)
68
(63 to 76)
69
(62 to 75)
69
(62 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 249 participants 245 participants 245 participants 739 participants
Female
45
  18.1%
65
  26.5%
49
  20.0%
159
  21.5%
Male
204
  81.9%
180
  73.5%
196
  80.0%
580
  78.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 249 participants 245 participants 245 participants 739 participants
249 245 245 739
1.Primary Outcome
Title Postoperative Blood Loss
Time Frame 12 hours postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline
Hide Arm/Group Description:

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.

Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

In this arm the subjects receives as in standard care no pericardial lavage.

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Overall Number of Participants Analyzed 249 245 245
Median (Inter-Quartile Range)
Unit of Measure: ml
290
(210 to 410)
300
(190 to 450)
290
(190 to 430)
2.Secondary Outcome
Title Number of Participants Requiring Surgical Re-exploration
Hide Description the secondary objective of this study is to determine whether pericardial lavage with saline gives an improvement in haemostasis, compared with no pericardial lavage, resulting in a reduction of surgical re-explorations and post-operative 12-hour blood loss. The choice for a surgical re-exploration will be decided according to the ICU protocol.
Time Frame participants will be followed for the duration of ICU stay, an expected average of 2 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline
Hide Arm/Group Description:

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.

Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

In this arm the subjects receives as in standard care no pericardial lavage.

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Overall Number of Participants Analyzed 249 245 245
Measure Type: Number
Unit of Measure: participants
10 9 12
3.Secondary Outcome
Title Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)
Hide Description The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.
Time Frame participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline
Hide Arm/Group Description:

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.

Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

In this arm the subjects receives as in standard care no pericardial lavage.

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Overall Number of Participants Analyzed 249 245 245
Mean (Standard Deviation)
Unit of Measure: IU
0.7  (1.6) 1.1  (3.2) 0.7  (1.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline
Hide Arm/Group Description

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.

Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

In this arm the subjects receives as in standard care no pericardial lavage.

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

All-Cause Mortality
Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/250 (2.80%)   4/250 (1.60%)   4/250 (1.60%) 
Cardiac disorders       
Death   4/250 (1.60%)  2/250 (0.80%)  2/250 (0.80%) 
General disorders       
cerebrovascular accident   3/250 (1.20%)  1/250 (0.40%)  2/250 (0.80%) 
epileptic seizures   0/250 (0.00%)  1/250 (0.40%)  0/250 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pericardial Lavage With 200 ml Normothermic Saline Solution No Pericardial Lavage 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/250 (0.00%)   0/250 (0.00%)   0/250 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Thierry V Scohy
Organization: Amphia Hospital
Phone: 0031765955570
Responsible Party: Thierry V Scohy, Amphia Hospital
ClinicalTrials.gov Identifier: NCT01895101     History of Changes
Other Study ID Numbers: TA-1251
2013-000774-30 ( EudraCT Number )
First Submitted: June 25, 2013
First Posted: July 10, 2013
Results First Submitted: March 30, 2015
Results First Posted: April 10, 2015
Last Update Posted: May 20, 2015