Contact information
Type
Scientific
Primary contact
Dr Juan Jose Jimenez
ORCID ID
Contact details
Ofra s/n. La Cuesta
La Laguna
38320
Spain
jjjimenezrivera@gmail.com
Additional identifiers
EudraCT number
2004-001366-41
ClinicalTrials.gov number
Protocol/serial number
TX/05 v.2; EudraCT: 2004-001366-41
Study information
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
Acronym
Study hypothesis
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
The local medical ethics committee (Comite Etico de Investigacion Clinica del Hospital Universitario De Canarias) approved on the 1st March 2005
Study design
Randomised double-blind phase IV clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase IV
Drug names
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 trial start date
01/12/2005
Overall trial end date
01/01/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Equal or older than 18 years old, either sex
2. Elective cardiopulmonary bypass surgery
3. Informed consent approval
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Participant 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
Recruitment start date
01/12/2005
Recruitment end date
01/01/2007
Locations
Countries of recruitment
Spain
Trial participating centre
Ofra s/n. La Cuesta
La Laguna
38320
Spain
Sponsor information
Organisation
Hospital Universitario de Canarias (Spain)
Sponsor details
Ofra s/n. La Cuesta
La Laguna
S.C. Tenerife
38320
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canary Islands Foundation of Health Research (Fundación Canaria de Investigación y Salud [FUNCIS]) (Spain) (ref: 48/04)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21999189
Publication citations
-
Results
Jiménez JJ, Iribarren JL, Brouard M, Hernández D, Palmero S, Jiménez A, Lorente L, Machado P, Borreguero JM, Raya JM, Martín B, Pérez R, Martínez R, Mora ML, Safety and effectiveness of two treatment regimes with tranexamic acid to minimize inflammatory response in elective cardiopulmonary bypass patients: a randomized double-blind, dose-dependent, phase IV clinical trial., J Cardiothorac Surg, 2011, 6, 138, doi: 10.1186/1749-8090-6-138.