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Trial record 86 of 422 for:    TRANEXAMIC ACID

Prospective Trial of Tranexamic Acid in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01998438
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : February 26, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Hongwen Ji, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary:
Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.

Condition or disease Intervention/treatment Phase
C.Surgical Procedure; Cardiac Drug: Tranexamic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 955 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery
Study Start Date : September 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: small dose
10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery
Drug: Tranexamic Acid
The loading doses were given in 15 minutes when incision.
Other Names:
  • SINE
  • Tranexamic Acid Injection
  • 120902

Experimental: medium dose
20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery
Drug: Tranexamic Acid
The loading doses were given in 15 minutes when incision.
Other Names:
  • SINE
  • Tranexamic Acid Injection
  • 120902

Experimental: large dose
30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery
Drug: Tranexamic Acid
The loading doses were given in 15 minutes when incision.
Other Names:
  • SINE
  • Tranexamic Acid Injection
  • 120902




Primary Outcome Measures :
  1. Postoperative Blood Loss [ Time Frame: 24hrs postoperatively ]

Secondary Outcome Measures :
  1. Number of Participants Needs Allogenic Transfusion [ Time Frame: on the 7th day postoperatively ]

Other Outcome Measures:
  1. Rate of Reexploration for Bleeding [ Time Frame: on the 7th day postoperatively ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
  • Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
  • Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass

Exclusion Criteria:

  • Non-primary and emergency cardiac surgery
  • Disorder in coagulation function before surgery
  • Anemia before surgery
  • Definite liver and renal dysfunction
  • History of stroke
  • Pregnancy and lactation
  • Disabled in spirit or law
  • Fatal conditions such as cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998438


Locations
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China, Beijing
Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Beijing, Beijing, China, 100037
Sponsors and Collaborators
Hongwen Ji
Investigators
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Study Chair: Hongwen Ji, MD Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
Principal Investigator: Haisong Lu Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC

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Responsible Party: Hongwen Ji, professor of medicine, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01998438     History of Changes
Other Study ID Numbers: 2011GWH1
First Posted: November 28, 2013    Key Record Dates
Results First Posted: February 26, 2016
Last Update Posted: February 26, 2016
Last Verified: January 2016
Keywords provided by Hongwen Ji, Chinese Academy of Medical Sciences, Fuwai Hospital:
tranexamic acid
cardiac surgery
cardiopulmonary bypass
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants