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Trial record 87 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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition C.Surgical Procedure; Cardiac
Intervention Drug: Tranexamic Acid
Enrollment 955
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Small Dose Medium Dose Large Dose
Hide Arm/Group Description

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

Period Title: Overall Study
Started 319 318 318
Completed 319 318 318
Not Completed 0 0 0
Arm/Group Title Small Dose Medium Dose Large Dose Total
Hide Arm/Group Description

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

Total of all reporting groups
Overall Number of Baseline Participants 319 318 318 955
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 319 participants 318 participants 318 participants 955 participants
53.1  (10.9) 53.2  (11.8) 53.1  (11.6) 53.1  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 319 participants 318 participants 318 participants 955 participants
Female
137
  42.9%
138
  43.4%
138
  43.4%
413
  43.2%
Male
182
  57.1%
180
  56.6%
180
  56.6%
542
  56.8%
1.Primary Outcome
Title Postoperative Blood Loss
Hide Description [Not Specified]
Time Frame 24hrs postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Small Dose Medium Dose Large Dose
Hide Arm/Group Description:

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

Overall Number of Participants Analyzed 319 318 318
Median (Inter-Quartile Range)
Unit of Measure: ml
520
(350 to 690)
490
(350 to 690)
450
(324.5 to 620)
2.Secondary Outcome
Title Number of Participants Needs Allogenic Transfusion
Hide Description [Not Specified]
Time Frame on the 7th day postoperatively
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Rate of Reexploration for Bleeding
Hide Description [Not Specified]
Time Frame on the 7th day postoperatively
Outcome Measure Data Not Reported
Time Frame 7 days postoperative
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Small Dose Medium Dose Large Dose
Hide Arm/Group Description

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

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

Tranexamic Acid: The loading doses were given in 15 minutes when incision.

All-Cause Mortality
Small Dose Medium Dose Large Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Small Dose Medium Dose Large Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/319 (10.66%)      42/318 (13.21%)      29/318 (9.12%)    
Cardiac disorders       
usage of IABP   2/319 (0.63%)  2 1/318 (0.31%)  1 1/318 (0.31%)  1
Nervous system disorders       
cerebral embolism   2/319 (0.63%)  2 1/318 (0.31%)  1 0/318 (0.00%)  0
Renal and urinary disorders       
renal dysfunction  1  30/319 (9.40%)  30 40/318 (12.58%)  40 28/318 (8.81%)  28
Indicates events were collected by systematic assessment
1
Term from vocabulary, renal dysfunction
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Small Dose Medium Dose Large Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/319 (0.63%)      3/318 (0.94%)      2/318 (0.63%)    
Infections and infestations       
wound infection   2/319 (0.63%)  2 3/318 (0.94%)  3 2/318 (0.63%)  2
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Hongwen Ji
Organization: Fuwai Hospital
Phone: +86 13701229553
EMail: jihongwen@hotmail.com
Layout table for additonal information
Responsible Party: Hongwen Ji, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT01998438     History of Changes
Other Study ID Numbers: 2011GWH1
First Submitted: November 12, 2013
First Posted: November 28, 2013
Results First Submitted: January 29, 2016
Results First Posted: February 26, 2016
Last Update Posted: February 26, 2016