Trial · NCT01895101
The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients
NCT01895101, Phase 4, Completed, Amphia Hospital; results first posted 2015-04-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients. Trials, record NCT01895101. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01895101
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients
- NCT number
- NCT01895101
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 750 participants, actual
- Lead sponsor
- Amphia Hospital
- Conditions
- Blood Loss, Tranexamic Acid, Cardiac Surgery
- Interventions
- 2 gr tranexamic acid, Saline
- First posted
- 2013-07-10
- Last updated
- 2015-05-20
- Other registries' IDs
- eudract:2013-000774-30
- Results first posted
- 2015-04-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Postoperative Blood Loss | 12 hours postoperative | ml | MEDIAN | |
| SECONDARY | Number of Participants Requiring Surgical Re-exploration | participants will be followed for the duration of ICU stay, an expected average of 2 days | participants | NUMBER | |
| SECONDARY | 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 | IU | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Postoperative Blood Loss | Pericardial Lavage With 200 ml Normothermic Saline Solution | 290 | Inter-Quartile Range 210 to 410 | ml | |
| Postoperative Blood Loss | No Pericardial Lavage | 300 | Inter-Quartile Range 190 to 450 | ml | |
| Postoperative Blood Loss | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 290 | Inter-Quartile Range 190 to 430 | ml | |
| Number of Participants Requiring Surgical Re-exploration | Pericardial Lavage With 200 ml Normothermic Saline Solution | 10 | participants | ||
| Number of Participants Requiring Surgical Re-exploration | No Pericardial Lavage | 9 | participants | ||
| Number of Participants Requiring Surgical Re-exploration | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 12 | participants | ||
| Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period) | Pericardial Lavage With 200 ml Normothermic Saline Solution | 0.7 | Standard Deviation 1.6 | IU | |
| Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period) | No Pericardial Lavage | 1.1 | Standard Deviation 3.2 | IU | |
| Total Red Blood Cell Transfusions (Cumulative of Pre, Peri and Postoperative Period) | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 0.7 | Standard Deviation 1.5 | IU |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pericardial Lavage With 200 ml Normothermic Saline Solution | 250 | |
| Overall Study | STARTED | No Pericardial Lavage | 250 | |
| Overall Study | STARTED | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 250 | |
| Overall Study | COMPLETED | Pericardial Lavage With 200 ml Normothermic Saline Solution | 249 | |
| Overall Study | COMPLETED | No Pericardial Lavage | 245 | |
| Overall Study | COMPLETED | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 245 | |
| Overall Study | NOT COMPLETED | Pericardial Lavage With 200 ml Normothermic Saline Solution | 1 | |
| Overall Study | NOT COMPLETED | No Pericardial Lavage | 5 | |
| Overall Study | NOT COMPLETED | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 5 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | cerebrovascular accident | General disorders | Pericardial Lavage With 200 ml Normothermic Saline Solution | 3 | 250 | |
| serious | cerebrovascular accident | General disorders | No Pericardial Lavage | 1 | 250 | |
| serious | cerebrovascular accident | General disorders | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 2 | 250 | |
| serious | Death | Cardiac disorders | Pericardial Lavage With 200 ml Normothermic Saline Solution | 4 | 250 | |
| serious | Death | Cardiac disorders | No Pericardial Lavage | 2 | 250 | |
| serious | Death | Cardiac disorders | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 2 | 250 | |
| serious | epileptic seizures | General disorders | Pericardial Lavage With 200 ml Normothermic Saline Solution | 0 | 250 | |
| serious | epileptic seizures | General disorders | No Pericardial Lavage | 1 | 250 | |
| serious | epileptic seizures | General disorders | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 0 | 250 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pericardial Lavage With 200 ml Normothermic Saline Solution | ||
| Total, all-cause mortality | No Pericardial Lavage | ||
| Total, all-cause mortality | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | ||
| Total, other adverse events | Pericardial Lavage With 200 ml Normothermic Saline Solution | 0 | 250 |
| Total, other adverse events | No Pericardial Lavage | 0 | 250 |
| Total, other adverse events | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 0 | 250 |
| Total, serious adverse events | Pericardial Lavage With 200 ml Normothermic Saline Solution | 7 | 250 |
| Total, serious adverse events | No Pericardial Lavage | 4 | 250 |
| Total, serious adverse events | 2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline | 4 | 250 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01895101
GET https://conductscience.org/api/trials/v1/NCT01895101/registered