Condition category
Injury, Occupational Diseases, Poisoning
Date applied
10/06/2009
Date assigned
15/07/2009
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.huc.es

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21999189

Publication citations

  1. 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.

Additional files

Editorial Notes