Trial Outcomes & Findings for The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients (NCT NCT01895101)

NCT ID: NCT01895101

Last Updated: 2015-05-20

Results Overview

The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 750 participants
• Primary outcome timeframe: 12 hours postoperative
• Results posted on: 2015-05-20

Participant Flow

Participant milestones

Measure	Pericardial Lavage With 200 ml Normothermic Saline Solution 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	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. In this arm the subjects receives as in standard care no pericardial lavage.	2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline 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 Study STARTED	250	250	250
Overall Study COMPLETED	249	245	245
Overall Study NOT COMPLETED	1	5	5

Reasons for withdrawal

Measure	Pericardial Lavage With 200 ml Normothermic Saline Solution 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	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. In this arm the subjects receives as in standard care no pericardial lavage.	2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline 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 Study OPCAB procedure	1	1	3
Overall Study Withdrawal by Subject	0	1	2
Overall Study another study, enrolled in other study	0	1	0
Overall Study Death	0	1	0
Overall Study coagulation disorder	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pericardial Lavage With 200 ml Normothermic Saline Solution n=249 Participants 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	No Pericardial Lavage n=245 Participants 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.	2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline n=245 Participants 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 n=739 Participants Total of all reporting groups
Age, Continuous	68 years n=5 Participants	68 years n=7 Participants	69 years n=5 Participants	69 years n=4 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	65 Participants n=7 Participants	49 Participants n=5 Participants	159 Participants n=4 Participants
Sex: Female, Male Male	204 Participants n=5 Participants	180 Participants n=7 Participants	196 Participants n=5 Participants	580 Participants n=4 Participants
Region of Enrollment Netherlands	249 participants n=5 Participants	245 participants n=7 Participants	245 participants n=5 Participants	739 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 hours postoperative

The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure

Outcome measures

Measure	Pericardial Lavage With 200 ml Normothermic Saline Solution n=249 Participants 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	No Pericardial Lavage n=245 Participants 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.	2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline n=245 Participants 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%).
Postoperative Blood Loss	290 ml Interval 210.0 to 410.0	300 ml Interval 190.0 to 450.0	290 ml Interval 190.0 to 430.0

SECONDARY outcome

Timeframe: participants will be followed for the duration of ICU stay, an expected average of 2 days

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.

Outcome measures

Measure	Pericardial Lavage With 200 ml Normothermic Saline Solution n=249 Participants 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	No Pericardial Lavage n=245 Participants 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.	2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline n=245 Participants 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%).
Number of Participants Requiring Surgical Re-exploration	10 participants	9 participants	12 participants

SECONDARY outcome

Timeframe: 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

The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.

Outcome measures

Measure	Pericardial Lavage With 200 ml Normothermic Saline Solution n=249 Participants 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	No Pericardial Lavage n=245 Participants 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.	2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline n=245 Participants 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 Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)	0.7 IU Standard Deviation 1.6	1.1 IU Standard Deviation 3.2	0.7 IU Standard Deviation 1.5

Adverse Events

Pericardial Lavage With 200 ml Normothermic Saline Solution

Serious events: 7 serious events

Other events: 0 other events

Deaths: 0 deaths

No Pericardial Lavage

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pericardial Lavage With 200 ml Normothermic Saline Solution n=250 participants at risk 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	No Pericardial Lavage n=250 participants at risk 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.	2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline n=250 participants at risk 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%).
General disorders cerebrovascular accident	1.2% 3/250	0.40% 1/250	0.80% 2/250
Cardiac disorders Death	1.6% 4/250	0.80% 2/250	0.80% 2/250
General disorders epileptic seizures	0.00% 0/250	0.40% 1/250	0.00% 0/250

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thierry V Scohy

Amphia Hospital

Phone: 0031765955570

Email: tscohy@amphia.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place