NCT00375466

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 13, 2012

Status Verified

December 1, 2012

Enrollment Period

2.3 years

First QC Date

September 12, 2006

Last Update Submit

December 12, 2012

Conditions

Hemorrhage

Keywords

HemorrhageTransfusionBlood componentsFibrinolysisPlatelet activation

Outcome Measures

Primary Outcomes (1)

  • Transfusion of blood components

    Intraoperatively and during postoperative stay

Secondary Outcomes (4)

  • Postoperative hemorrhage

    First 16 hours postoperatively

  • Fibrinolysis

    20 hours postoperatively

  • Platelet activation

    20 hours postoperatively

  • Activation of coagulation

    20 hours postoperatively

Study Arms (2)

Tranexamic Acid

EXPERIMENTAL
Drug: Tranexamic acid

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

Tranexamic acidDRUG

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.

Also known as: Cykokapron ACT: B02A A02
Tranexamic Acid
placeboDRUG

0.9% sodium chloride 10 mg/kg, as a bolus injection before surgery followed by 1 mg/kg/h as an infusion during surgery

placebo

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olav University Hospital

Trondheim, 7006, Norway

Location

Related Publications (1)

  • Greiff G, Stenseth R, Wahba A, Videm V, Lydersen S, Irgens W, Bjella L, Pleym H. Tranexamic acid reduces blood transfusions in elderly patients undergoing combined aortic valve and coronary artery bypass graft surgery: a randomized controlled trial. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):232-8. doi: 10.1053/j.jvca.2011.07.010. Epub 2011 Sep 15.

    PMID: 21924636RESULT

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Hilde Pleym, MD, PhD

    St. Olavs Hospital

    STUDY CHAIR

  • Guri Greiff, MD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

  • Alexander Wahba, MD, PhD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

  • Roar Stenseth, MD, PhD

    St. Olavs Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

December 13, 2012

Record last verified: 2012-12

Locations

NO(1)