Randomised, double-blind, controlled study of the tranexamic acid prophylaxis efficacy on the development of systemic inflammatory response syndrome and postoperative bleeding in cardiopulmonary bypass surgery patients
| ISRCTN | ISRCTN05718824 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05718824 |
| Secondary identifying numbers | Tranexamico/2002 |
- Submission date
- 21/03/2007
- Registration date
- 18/05/2007
- Last edited
- 05/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jose Luis Iribarren
Scientific
Scientific
Ofra s/n
La Laguna
38320
Spain
Study information
| Study design | Randomised, double-blind, controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Randomised, double-blind, controlled study of the tranexamic acid prophylaxis efficacy on the development of systemic inflammatory response syndrome and postoperative bleeding in cardiopulmonary bypass surgery patients |
| Study acronym | TX/02 |
| Study objectives | We hypothesised that the inhibition of fibrinolysis through the administration of tranexamic acid could reduce the incidence of systemic inflammatory response syndrome and postoperative bleeding after cardiopulmonary bypass. |
| Ethics approval(s) | Approval received from the University Hospital of Canary Islands Ethics and Research Council on the 20th December 2001 (ref: 35/01). |
| Health condition(s) or problem(s) studied | Systemic inflammatory response syndrome |
| Intervention | Infusions of either tranexamic acid or placebo (0.9% saline), with doses of 2 g pre- and post-cardiopulmonary bypass after protamine administration. Follow-up continued until the patient was discharged from the hospital. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Tranexamic acid, protamine |
| Primary outcome measure | To investigate the efficacy of tranexamic acid in decreasing the incidence of systemic inflammatory response syndrome and postoperative bleeding. Data was recorded preoperatively, after surgery, at Intensive Care Unit admission (0 hours), four hours and 24 hours. |
| Secondary outcome measures | To investigate the efficacy of tranexamic acid to reduce excessive postoperative bleeding in patients undergoing cardiac surgery, according to the presence of different genotypes of the Plasminogen Activator Inhibitor (PAI-1) gene. Data was recorded preoperatively, after surgery, at Intensive Care Unit admission (0 hours), four hours and 24 hours. |
| Overall study start date | 01/06/2002 |
| Completion date | 01/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 50 |
| Key inclusion criteria | Consecutive Caucasian adults undergoing elective cardiopulmonary bypass surgery with normal aggregation and coagulation test values. |
| Key exclusion criteria | 1. Emergency interventions 2. Patients with a history of haemostatic dysfunction 3. Renal failure (creatinine greater than 2 mg/dl) 4. Chronic hepatopathy 5. Immunodepressed patients 6. Sepsis |
| Date of first enrolment | 01/06/2002 |
| Date of final enrolment | 01/09/2003 |
Locations
Countries of recruitment
- Spain
Study participating centre
Ofra s/n
La Laguna
38320
Spain
38320
Spain
Sponsor information
University Hospital of Canary Islands (Consorcio Sanitario de Tenerife [CST]) (Spain)
Hospital/treatment centre
Hospital/treatment centre
c/o Juan José Jiménez Rivera
Ofra s/n
La Laguna
38320
Spain
| Website | http://www.hecit.es/index.html |
|---|---|
"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: 2202)
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 | 01/08/2007 | 05/01/2021 | Yes | No |
Editorial Notes
05/01/2021: Publication reference and total final enrolment added.
