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

Ofra s/n. La Cuesta
La Laguna
38320
Spain

Email jjjimenezrivera@gmail.com

Study information

Study designRandomised double-blind phase IV clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised 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 objectivesHyperfibrinolysis 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) studiedSystemic inflammatory response syndrome (SIRS), post-operative bleeding
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Tranexamic acid, protamine
Primary outcome measureBiochemical 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 measures1. 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 date01/12/2005
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants160
Key inclusion criteria1. Equal or older than 18 years old, either sex
2. Elective cardiopulmonary bypass surgery
3. Informed consent approval
Key exclusion criteria1. 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 enrolment01/12/2005
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • Spain

Study participating centre

Ofra s/n. La Cuesta
La Laguna
38320
Spain

Sponsor information

Hospital Universitario de Canarias (Spain)
Hospital/treatment centre

Ofra s/n. La Cuesta
La Laguna
S.C. Tenerife
38320
Spain

Website http://www.huc.es
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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