Blood Loss, Cardiac Surgery, Tranexamic Acid
Conditions
Keywords
blood loss, tranexamix acid, cardiac surgery
Brief summary
It remains still unclear whether topical tranexamic acid has an added value besides the administration of intravenously tranexamic acid. We hypothesize that the addition of topical tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25% reduction of post-operative blood loss after cardiac surgery. The aim of this study is to determine whether the application of topical tranexamic acid reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated. Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group) receives no pericardial lavage. The main study parameter is 12 hours post-operative blood loss and is assessed by 12 hours post-operative chest tube production.
Interventions
DRUG2 gr tranexamic acid
This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).
DRUGSaline
This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid
Sponsors
Amphia Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Gender; male/ female * Age: ≥ 18 year * Elective cardiac surgical patients * Coronary artery bypass graft (CABG) (conventional, E.CCO) * Aortic valve replacement (AVR) (conventional) * Mitral valve replacement (MVR)/ Mitral valve repairment (MPL) (conventional) * Tricuspid valve replacement (TVR) / Tricuspid valve repairment (TPL) * Bentall * Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/Maze)
Exclusion criteria
* MVR/MPL (minimal invasive, Port Access Surgery) * Maze (minimal invasive, via Thoracoscopy) * AVR (minimal invasive, via mini Sternotomy) * off-pump procedures * Emergency operations * Patient with increased or decreased blooding tendency (FV leiden, prot C, S deficiency, anti-thrombin deficiency, prothrombin mutation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Blood Loss | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Requiring Surgical Re-exploration | 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. |
| Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period) | 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. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 249 |
| 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. | 245 |
| 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%). | 245 |
| Total | 739 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | another study, enrolled in other study | 0 | 1 | 0 |
| Overall Study | coagulation disorder | 0 | 1 | 0 |
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | OPCAB procedure | 1 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Pericardial Lavage With 200 ml Normothermic Saline Solution | No Pericardial Lavage | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | Total |
|---|---|---|---|---|
| Age, Continuous | 68 years | 68 years | 69 years | 69 years |
| Region of Enrollment Netherlands | 249 participants | 245 participants | 245 participants | 739 participants |
| Sex: Female, Male Female | 45 Participants | 65 Participants | 49 Participants | 159 Participants |
| Sex: Female, Male Male | 204 Participants | 180 Participants | 196 Participants | 580 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 250 | 0 / 250 | 0 / 250 |
| serious Total, serious adverse events | 7 / 250 | 4 / 250 | 4 / 250 |
Outcome results
Primary
Postoperative Blood Loss
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
Time frame: 12 hours postoperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pericardial Lavage With 200 ml Normothermic Saline Solution | Postoperative Blood Loss | 290 ml |
| No Pericardial Lavage | Postoperative Blood Loss | 300 ml |
| 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | Postoperative Blood Loss | 290 ml |
Secondary
Number of Participants Requiring Surgical Re-exploration
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pericardial Lavage With 200 ml Normothermic Saline Solution | Number of Participants Requiring Surgical Re-exploration | 10 participants |
| No Pericardial Lavage | Number of Participants Requiring Surgical Re-exploration | 9 participants |
| 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | Number of Participants Requiring Surgical Re-exploration | 12 participants |
Secondary
Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pericardial Lavage With 200 ml Normothermic Saline Solution | Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period) | 0.7 IU | Standard Deviation 1.6 |
| No Pericardial Lavage | Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period) | 1.1 IU | Standard Deviation 3.2 |
| 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period) | 0.7 IU | Standard Deviation 1.5 |