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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000774-30 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pericardial lavage with 200 ml normothermic saline solution | Placebo Comparator | 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. |
|
| No pericardial lavage | No Intervention | 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 | Experimental | 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%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 gr tranexamic acid | Drug | This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Gender; male/ female
Age: ≥ 18 year
Elective cardiac surgical patients
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry Scohy | Amphia Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amphia Hospital | Breda | 4800 RK | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23063104 | Background | Mahaffey R, Wang L, Hamilton A, Phelan R, Arellano R. A retrospective analysis of blood loss with combined topical and intravenous tranexamic acid after coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2013 Feb;27(1):18-22. doi: 10.1053/j.jvca.2012.08.004. Epub 2012 Oct 10. | |
| 10694619 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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%). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | ml | 12 hours postoperative |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cerebrovascular accident | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thierry V Scohy | Amphia Hospital | 0031765955570 | tscohy@amphia.nl |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid |
|
| participants will be followed for the duration of ICU stay, an expected average of 2 days |
| 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. | 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 |
| De Bonis M, Cavaliere F, Alessandrini F, Lapenna E, Santarelli F, Moscato U, Schiavello R, Possati GF. Topical use of tranexamic acid in coronary artery bypass operations: a double-blind, prospective, randomized, placebo-controlled study. J Thorac Cardiovasc Surg. 2000 Mar;119(3):575-80. doi: 10.1016/s0022-5223(00)70139-5. |
| 17218108 | Background | Baric D, Biocina B, Unic D, Sutlic Z, Rudez I, Vrca VB, Brkic K, Ivkovic M. Topical use of antifibrinolytic agents reduces postoperative bleeding: a double-blind, prospective, randomized study. Eur J Cardiothorac Surg. 2007 Mar;31(3):366-71; discussion 371. doi: 10.1016/j.ejcts.2006.12.003. Epub 2007 Jan 10. |
| 16438759 | Background | Abul-Azm A, Abdullah KM. Effect of topical tranexamic acid in open heart surgery. Eur J Anaesthesiol. 2006 May;23(5):380-4. doi: 10.1017/S0265021505001894. Epub 2006 Jan 27. |
| 21660523 | Background | Spegar J, Vanek T, Snircova J, Fajt R, Straka Z, Pazderkova P, Maly M. Local and systemic application of tranexamic acid in heart valve surgery: a prospective, randomized, double blind LOST study. J Thromb Thrombolysis. 2011 Oct;32(3):303-10. doi: 10.1007/s11239-011-0608-3. |
| another study, enrolled in other study |
|
| Death |
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| coagulation disorder |
|
| BG001 | 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. |
| BG002 | 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%). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
| OG002 | 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%). |
|
|
| 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. | Posted | Number | participants | participants will be followed for the duration of ICU stay, an expected average of 2 days |
|
|
|
| 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. | Posted | Mean | Standard Deviation | IU | 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 |
|
|
|
| 7 |
| 250 |
| 0 |
| 250 |
| EG001 | 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. | 4 | 250 | 0 | 250 |
| EG002 | 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%). | 4 | 250 | 0 | 250 |
| Death | Cardiac disorders | Systematic Assessment |
|
| epileptic seizures | General disorders | Systematic Assessment |
|
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| D017670 |
| Sodium Compounds |