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Trial record 6 of 419 for:    TRANEXAMIC ACID

Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03838328
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital

Brief Summary:
In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.

Condition or disease Intervention/treatment Phase
Thromboses, Deep Vein Tranexamic Acid Adverse Reaction Drug: Tranexamic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The allocation is masked for the participant, care provider, investigator and outcomes assessor.
Primary Purpose: Treatment
Official Title: Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery With Cardiopulmonary Bypass
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose group 1
The dose regimen of tranexamic acid in group 1 includes a loading dose of 30mg/kg before skin incision and a maintenance dose of 20mg/kg/hr until the end of the operation.
Drug: Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.

Experimental: Dose group 2
The dose regimen of tranexamic acid in group 2 includes a loading dose of 20mg/kg before skin incision and a maintenance dose of 15mg/kg/hr until the end of the operation.
Drug: Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.

Active Comparator: Dose group 3
The dose regimen of tranexamic acid in group 3 includes a loading dose of 10mg/kg before skin incision and a maintenance dose of 10mg/kg/hr until the end of the operation.
Drug: Tranexamic Acid
Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.




Primary Outcome Measures :
  1. The incidence of deep venous thrombosis [ Time Frame: Within 7 days postoperatively ]
    Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound


Secondary Outcome Measures :
  1. The rate of new-onset thrombotic events [ Time Frame: Within 90 days postoperatively ]
    Thrombotic events include ischemic stroke, renal failure, myocardial infarction and pulmonary embolism

  2. The rate of allogeneic RBC transfusion [ Time Frame: Within 30 days postoperatively ]
    Allogeneic blood product includes packed red blood cell

  3. The volume of allogeneic RBC transfusion [ Time Frame: Within 30 days postoperatively ]
    Allogeneic blood product includes packed red blood cell

  4. Length of stay in ICU and hospital [ Time Frame: Within 90 days postoperatively ]
    The time interval between the end of the operation and the discharge from ICU or the hospital.



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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:

  • Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
  • Written consent obtained

Exclusion Criteria:

  • Allergy or contraindication to tranexamic acid
  • Severe renal impairment (serum creatinine >250 μmol/l, or estimated creatinine clearance <25 ml/min)
  • Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
  • Thrombocytopenia defined as a platelet count <100,000/ml
  • Coagulopathy defined as an international normalized ratio > 1.5 prior to surgery
  • Currently enrolled in another perioperative interventional study
  • Pregnancy or lactation

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): NCT03838328


Contacts
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Contact: Jia Shi, M.D. 86 10 88322467 shiandypumc@sina.com

Locations
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China
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, China, 100037
Sponsors and Collaborators
SHI Jia
Investigators
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Principal Investigator: Jia Shi, M.D. Fuwai Hospital

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Responsible Party: SHI Jia, Associate Professor and Vice Chair of the Anesthesiology Department, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03838328     History of Changes
Other Study ID Numbers: Dose effect of TA on DVT
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SHI Jia, Chinese Academy of Medical Sciences, Fuwai Hospital:
dose effect
tranexamic acid
deep vein thromboses
Additional relevant MeSH terms:
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Tranexamic Acid
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants