Tranexamic Acid, Hemorrhage and Transfusions After Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00375466
First received: September 12, 2006
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

In this study we will investigate whether tranexamic acid given as an intravenous bolus injection before start of surgery, followed by a continuous infusion during surgery reduces, perioperative hemostatic activation, and postoperative bleeding and the need for transfusions of blood components in elderly patients undergoing combined aortic valve replacement and coronary artery bypass surgery. Tranexamic acid will be compared with placebo (0.9% sodium chloride) in a randomized and double-blind study design.

The study hypothesis is that tranexamic acid will reduce hemostatic activation and postoperative hemorrhage and the need for blood component transfusions in this group of patients.


Condition Intervention
Hemorrhage
Drug: Tranexamic acid
Drug: placebo

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: Phase 4 Study of Tranexamic Acid for Elderly Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Surgery.

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Transfusion of blood components [ Time Frame: Intraoperatively and during postoperative stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative hemorrhage [ Time Frame: First 16 hours postoperatively ] [ Designated as safety issue: No ]
  • Fibrinolysis [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]
  • Platelet activation [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]
  • Activation of coagulation [ Time Frame: 20 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 63
Study Start Date: September 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic Acid Drug: Tranexamic acid
Tranexamic acid 10 mg/kg as a bolus dose followed by an infusion of 1 mg/kg/hour. Bolus given before start of surgery, infusion continued during surgery.
Other Name: Cykokapron ACT: B02A A02
Placebo Comparator: placebo Drug: placebo
0.9% sodium chloride 10 mg/kg, as a bolus injection before surgery followed by 1 mg/kg/h as an infusion during surgery

Detailed Description:

It has previously been shown that elderly patients show signs of increased perioperative hemostatic activation after coronary artery bypass grafting. In particular, compared to younger patients, elderly patients had more extensive fibrinolysis postoperatively. The antifibrinolytic drug tranexamic acid has been shown to reduce fibrinolysis, bleeding, and the need for transfusions of blood components after various cardiac surgical procedures. In this study we will investigate whether tranexamic acid reduces perioperative activation of coagulation as measured by plasma concentrations of antithrombin, thrombin-antithrombin complex, and prothrombin fragment 1+2, whether tranexamic acid reduces perioperative fibrinolysis as measured by plasma concentrations of D-dimer, and whether tranexamic acid reduces platelet activation as measured by plasma concentrations of neutrophil activating peptide 2 and by flow cytometry in elderly (above 70 years of age) patients undergoing combined aortic valve replacement and coronary artery bypass surgery. The primary endpoint of the study will, however, be total postoperative bleeding and the need for transfusions of blood components during and after surgery. The need for transfusions will be registered during the whole hospital stay. Patients will be randomized into two groups and given either tranexamic acid or placebo (0.9% sodium chloride) as an intravenous bolus injection before start of surgery followed by an intravenous infusion during surgery. Blood samples for the above mentioned plasma concentration measurements will be drawn preoperatively, intraoperatively during CPB, and 30 minutes and 3, 5, and 20 hours postoperatively. Postoperative bleeding will be registered for 16 hours. The need for any transfusions of blood products will be registered for the whole hospital stay.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients above 70 years of age scheduled for combined aortic valve replacement and coronary artery bypass surgery.

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Exclusion Criteria: Patients younger than 70 years of age. Patients scheduled for other procedures than combined aortic valve replacement and coronary artery bypass surgery. Patients who are not treated with aspirin. Patients with a medical condition known to influence the hemostatic system. Patients treated with drugs other than aspirin during the last week before surgery that may influence the hemostatic system, such as warfarin (coumarin), non-steroidal antiinflammatory drugs, clopidogrel, heparin, low molecular heparins. Patients who are treated with systemic steroids. Patients with a serum creatinin concentration above 140 micromol/l. Patients with an INR above 1.5. Patients who are not able to give written informed concent.

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  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: NCT00375466

Locations
Norway
St. Olav University Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Study Chair: Hilde Pleym, MD, PhD St. Olavs Hospital
Principal Investigator: Guri Greiff, MD St. Olavs Hospital
Principal Investigator: Alexander Wahba, MD, PhD St. Olavs Hospital
Principal Investigator: Roar Stenseth, MD, PhD St. Olavs Hospital
  More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00375466     History of Changes
Other Study ID Numbers: 4.2006.1285, 2006-004561-34
Study First Received: September 12, 2006
Last Updated: December 12, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services

Keywords provided by St. Olavs Hospital:
Hemorrhage
Transfusion
Blood components
Fibrinolysis
Platelet activation

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

ClinicalTrials.gov processed this record on October 19, 2014