Trial Outcomes & Findings for Prospective Trial of Tranexamic Acid in Cardiac Surgery (NCT NCT01998438)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

955 participants

Primary outcome timeframe

24hrs postoperatively

Results posted on

2016-02-26

Participant Flow

Participant milestones

Participant milestones
Measure	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 Tranexamic Acid: The loading doses were given in 15 minutes when incision.	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 Tranexamic Acid: The loading doses were given in 15 minutes when incision.	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 Tranexamic Acid: The loading doses were given in 15 minutes when incision.
Overall Study STARTED	319	318	318
Overall Study COMPLETED	319	318	318
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Trial of Tranexamic Acid in Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Small Dose n=319 Participants 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.	Medium Dose n=318 Participants 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.	Large Dose n=318 Participants 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 n=955 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 10.9 • n=5 Participants	53.2 years STANDARD_DEVIATION 11.8 • n=7 Participants	53.1 years STANDARD_DEVIATION 11.6 • n=5 Participants	53.1 years STANDARD_DEVIATION 11.4 • n=4 Participants
Sex: Female, Male Female	137 Participants n=5 Participants	138 Participants n=7 Participants	138 Participants n=5 Participants	413 Participants n=4 Participants
Sex: Female, Male Male	182 Participants n=5 Participants	180 Participants n=7 Participants	180 Participants n=5 Participants	542 Participants n=4 Participants

PRIMARY outcome

Timeframe: 24hrs postoperatively

Outcome measures

Outcome measures
Measure	Small Dose n=319 Participants 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.	Medium Dose n=318 Participants 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.	Large Dose n=318 Participants 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.
Postoperative Blood Loss	520 ml Interval 350.0 to 690.0	490 ml Interval 350.0 to 690.0	450 ml Interval 324.5 to 620.0

SECONDARY outcome

Timeframe: on the 7th day postoperatively

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: on the 7th day postoperatively

Outcome measures

Outcome data not reported

Adverse Events

Small Dose

Serious events: 34 serious events

Other events: 2 other events

Deaths: 0 deaths

Medium Dose

Serious events: 42 serious events

Other events: 3 other events

Deaths: 0 deaths

Large Dose

Serious events: 29 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Small Dose n=319 participants at risk 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.	Medium Dose n=318 participants at risk 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.	Large Dose n=318 participants at risk 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.
Renal and urinary disorders renal dysfunction	9.4% 30/319 • Number of events 30 • 7 days postoperative	12.6% 40/318 • Number of events 40 • 7 days postoperative	8.8% 28/318 • Number of events 28 • 7 days postoperative
Cardiac disorders usage of IABP	0.63% 2/319 • Number of events 2 • 7 days postoperative	0.31% 1/318 • Number of events 1 • 7 days postoperative	0.31% 1/318 • Number of events 1 • 7 days postoperative
Nervous system disorders cerebral embolism	0.63% 2/319 • Number of events 2 • 7 days postoperative	0.31% 1/318 • Number of events 1 • 7 days postoperative	0.00% 0/318 • 7 days postoperative

Other adverse events

Other adverse events
Measure	Small Dose n=319 participants at risk 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.	Medium Dose n=318 participants at risk 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.	Large Dose n=318 participants at risk 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.
Infections and infestations wound infection	0.63% 2/319 • Number of events 2 • 7 days postoperative	0.94% 3/318 • Number of events 3 • 7 days postoperative	0.63% 2/318 • Number of events 2 • 7 days postoperative

Additional Information

Dr. Hongwen Ji

Fuwai Hospital

Phone: +86 13701229553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place