The effectiveness of various groups of 24-hour tranexamic acid treatment in the prevention of systemic inflammatory response syndrome and post-operative bleeding in elective cardiopulmonary bypass patients
| ISRCTN | ISRCTN84413719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84413719 |
| EudraCT/CTIS number | 2004-001366-41 |
| Secondary identifying numbers | TX/05 v.2; EudraCT: 2004-001366-41 |
- Submission date
- 10/06/2009
- Registration date
- 15/07/2009
- Last edited
- 05/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Juan Jose Jimenez
Scientific
Scientific
Ofra s/n. La Cuesta
La Laguna
38320
Spain
| jjjimenezrivera@gmail.com |
Study information
| Study design | Randomised double-blind phase IV clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised double-blind phase IV clinical trial on 24 hours duration of various groups of tranexamic acid treatment on the effectiveness in the prevention of systemic inflammatory response syndrome and post-operative bleeding in elective cardiopulmonary bypass patients |
| Study objectives | Hyperfibrinolysis may play a role in systemic inflammatory response syndrome (SIRS) after cardiopulmonary bypass (CPB). Irregular inhibition of fibrinolysis with different doses of tranexamic acid may attenuate unequally SIRS after CPB. |
| Ethics approval(s) | The local medical ethics committee (Comite Etico de Investigacion Clinica del Hospital Universitario De Canarias) approved on the 1st March 2005 |
| Health condition(s) or problem(s) studied | Systemic inflammatory response syndrome (SIRS), post-operative bleeding |
| Intervention | Patients were randomly assigned by independent pharmacists using a list of pseudo-randomised numbers to receive coded infusions of either tranexamic acid (TA) (40 mg/kg pre-CPB and 40 mg/kg post-CPB) or TA (40 mg/kg pre-CPB and 0 mg/kg post-CPB) after protamine administration. Patients were followed-up from the first 24 hours after surgery up to ICU discharge. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Tranexamic acid, protamine |
| Primary outcome measure | Biochemical determinations and haemodynamics parameters, recorded before intervention (baseline), on admission to the ICU after surgery (0 hours), and at 4 hours, 12 hours and 24 hours after surgery |
| Secondary outcome measures | 1. Blood loss, measured by tube chest drainage and the amount of haemoderivatives used, as well as its frequency, collected after intervention on admission to the ICU after surgery (0 hours), and at 4 hours, 12 hours and 24 hours after surgery, and when chest tubes were removed 2. Mortality, measured from the first 24 hours after surgery up to ICU discharge 3. Mechanical ventilation time, measured from the first 24 hours after surgery up to ICU discharge 4. Vasopressor requirements, measured from the first 24 hours after surgery up to ICU discharge 5. ICU length of stay, measured from the first 24 hours after surgery up to ICU discharge |
| Overall study start date | 01/12/2005 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Key inclusion criteria | 1. Equal or older than 18 years old, either sex 2. Elective cardiopulmonary bypass surgery 3. Informed consent approval |
| Key exclusion criteria | 1. Younger than 18 years old 2. Tranexamic acid hypersensibility 3. Gross haematuria 4. Emergency interventions 5. Off-pump cardiac surgery 6. Patients with a history of: 6.1. Chronic coagulopathy (prothrombin time [PT] of less than 50% or international normalised ratio of greater than 2 and platelets of less than 50,000/mm^3 or aggregation dysfunction) 6.2. Renal failure (creatinine of greater than 2 mg/dl) 6.3. Chronic hepatopathy (Child B or higher degree) 6.4. Use of immunosuppressant drugs 6.5. Endocarditis, sepsis in the first 24 hours after intervention, or 6.6. Unwillingness to enrol 6.7. Use of anti-inflammatory agents such as corticosteroids or non-steroidal anti-inflammatory agents, on the previous 5 days before intervention |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- Spain
Study participating centre
Ofra s/n. La Cuesta
La Laguna
38320
Spain
38320
Spain
Sponsor information
Hospital Universitario de Canarias (Spain)
Hospital/treatment centre
Hospital/treatment centre
Ofra s/n. La Cuesta
La Laguna
S.C. Tenerife
38320
Spain
| Website | http://www.huc.es |
|---|---|
"ROR" |
https://ror.org/05qndj312 |
Funders
Funder type
Research organisation
Canary Islands Foundation of Health Research (Fundación Canaria de Investigación y Salud [FUNCIS]) (Spain) (ref: 48/04)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/10/2011 | Yes | No |
