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

NCT03838328 | Unknown Phase 4 DMC

• 1 other identifier: Dose effect of TA on DVT
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Thromboses, Deep Vein; Tranexamic Acid Adverse Reaction

Keywords

dose effect; tranexamic acid; deep vein thromboses

Outcome Measures

Primary Outcomes (1)

• The incidence of deep venous thrombosis

  Defined as the incidence of new-onset deep venous thrombosis postoperatively diagnosed by ultrasound

  Within 7 days postoperatively

Secondary Outcomes (4)

• The rate of new-onset thrombotic events

  Within 90 days postoperatively

• The rate of allogeneic RBC transfusion

  Within 30 days postoperatively

• The volume of allogeneic RBC transfusion

  Within 30 days postoperatively

• Length of stay in ICU and hospital

  Within 90 days postoperatively

Study Arms (3)

Dose group 1

EXPERIMENTAL

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

Dose group 2

EXPERIMENTAL

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

Dose group 3

ACTIVE COMPARATOR

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

Interventions

Tranexamic Acid DRUG

Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.

Dose group 1; Dose group 2; Dose group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SHI Jia: lead

Study Sites (1)

Chinese Academy of Medical Sciences， Fuwai Hospital

Beijing, 100037, China

Location

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jia Shi, M.D.

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jia Shi, M.D.

CONTACT

86 10 88322467; shiandypumc@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation is masked for the participant, care provider, investigator and outcomes assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor and Vice Chair of the Anesthesiology Department

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 12, 2019
• Study Start: March 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: March 31, 2020
• Last Updated: February 12, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)