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The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Amphia Hospital
Sponsor:
Information provided by (Responsible Party):
Thierry V Scohy, Amphia Hospital
ClinicalTrials.gov Identifier:
NCT01895101
First received: June 25, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

It remains still unclear whether topical tranexamic acid has an added value besides the administration of intravenously tranexamic acid. We hypothesize that the addition of topical tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25% reduction of post-operative blood loss after cardiac surgery.

The aim of this study is to determine whether the application of topical tranexamic acid reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.

Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group) receives no pericardial lavage. The main study parameter is 12 hours post-operative blood loss and is assessed by 12 hours post-operative chest tube production.


Condition Intervention Phase
Blood Loss
Tranexamic Acid
Cardiac Surgery
Drug: 2 gr tranexamic acid
Drug: Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect on Blood Loss of Topical and Intravenous Tranexamic Acid in Cardiac Surgery Patients: a Randomized Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Amphia Hospital:

Primary Outcome Measures:
  • postoperative blood loss [ Time Frame: 12 hours postoperative ] [ Designated as safety issue: No ]
    The primary study parameter is 12 hours postoperative blood loss and is assessed by postoperative chest tube production. Postoperative chest tube production 12 hours after surgical procedure


Secondary Outcome Measures:
  • surgical re-exploration [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days ] [ Designated as safety issue: No ]
    the secondary objective of this study is to determine whether pericardial lavage with saline gives an improvement in haemostasis, compared with no pericardial lavage, resulting in a reduction of surgical re-explorations and post-operative 12-hour blood loss. The choice for a surgical re-exploration will be decided according to the ICU protocol.

  • blood transfusions (amount) [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    The amount of red blood cell transfusions the patient receive pre, peri and postoperatively during their stay in the hospital.

  • Routine coagulation test: Fibrinogen level [ Time Frame: postoperative 1 hour/ And postoperative 24 hours ] [ Designated as safety issue: No ]
    The fibrinogen level will be measured post operative 1 hour and post operative 24 hours.

  • Thromboembolic events [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: Yes ]
    According to the ICU protocol, all patients will be neurologicly evaluated by the intensivist, a cerebrovascular accident (CVA) will be defined and registered by the physician.

  • Nadir Hb [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    Nadir Hb during postoperative ICU period & hospital stay will be measured

  • Nadir fibrinogen level [ Time Frame: participants will be followed for the duration of ICU stay, an expected average of 2 days/ And participants will be followed for the duration of hospital stay, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    Nadir fibrinogen level will be measured during postoperative ICU perdiod & hospital stay.


Estimated Enrollment: 750
Study Start Date: October 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: pericardial lavage with 200 ml normothermic saline solution

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.

Drug: Saline
This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid
No Intervention: No pericardial lavage

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

In this arm the subjects receives as in standard care no pericardial lavage.

Experimental: 2 gr tranexamic acid diluted in 200 ml normothermic saline

According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).

Drug: 2 gr tranexamic acid
This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gender; male/ female
  • Age: ≥ 18 year
  • Elective cardiac surgical patients

    • Coronary artery bypass graft (CABG) (conventional, E.CCO)
    • Aortic valve replacement (AVR) (conventional)
    • Mitral valve replacement (MVR)/ Mitral valve repairment (MPL) (conventional)
    • Tricuspid valve replacement (TVR) / Tricuspid valve repairment (TPL)
    • Bentall
    • Combined procedure (e.g. CABG/ AVR, MVR/AVR, AVR/Maze)

Exclusion Criteria:

  • MVR/MPL (minimal invasive, Port Access Surgery)
  • Maze (minimal invasive, via Thoracoscopy)
  • AVR (minimal invasive, via mini Sternotomy)
  • off-pump procedures
  • Emergency operations
  • Patient with increased or decreased blooding tendency (FV leiden, prot C, S deficiency, anti-thrombin deficiency, prothrombin mutation)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895101

Contacts
Contact: DM Kimenai 0031765955126 dkimenai@amphia.nl

Locations
Netherlands
Amphia Hospital Recruiting
Breda, Netherlands, 4800 RK
Contact: DM Kimenai    0031765955126    dkimenai@amphia.nl   
Sub-Investigator: DM Kimenai         
Principal Investigator: TV Scohy         
Sub-Investigator: BM Gerritse         
Sub-Investigator: CM Megens-Bastiaanse         
Sub-Investigator: M Bentala         
Sub-Investigator: PMJ Rosseel         
Sponsors and Collaborators
Amphia Hospital
Investigators
Principal Investigator: Thierry Scohy Amphia Hospital
  More Information

Publications:
Responsible Party: Thierry V Scohy, MD, phd, Amphia Hospital
ClinicalTrials.gov Identifier: NCT01895101     History of Changes
Other Study ID Numbers: TA-1251, 2013-000774-30
Study First Received: June 25, 2013
Last Updated: October 28, 2013
Health Authority: The Netherlands: Central Committee on Research Involving Human Subjects

Keywords provided by Amphia Hospital:
blood loss
tranexamix acid
cardiac surgery

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Pharmaceutical Solutions
Tranexamic Acid
Antifibrinolytic Agents
Coagulants
Fibrin Modulating Agents
Hematologic Agents
Hemostatics
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014