Trial Outcomes & Findings for Tranexamic Acid in Off-pump Coronary Surgery (NCT NCT01064167)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

231 participants

Primary outcome timeframe

1month postoperative

Results posted on

2011-02-03

Participant Flow

From February 2009 to December 2009, 378 consecutive patients in Fuwai hospital scheduled for elective OPCAB were enrolled in the study. 118 patients were excluded for randomizatin because not meeting inclusion criteria(n=29), Refused to participate(n=81),and surgery cancelled(n=8).

Of the 260 patients randomized, 130 were allocated to each group. 14 patients in tranexamic acid group and 15 in placebo group were withdrawn from the study for convert to on-pump surgery in course of surgery.

Participant milestones

Participant milestones
Measure	Tranexamic Acid Group Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.	Control Group The placebo consisted of an equivalent volume of saline solution.
Overall Study STARTED	130	130
Overall Study COMPLETED	116	115
Overall Study NOT COMPLETED	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Tranexamic Acid Group Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.	Control Group The placebo consisted of an equivalent volume of saline solution.
Overall Study Protocol Violation	14	15

Baseline Characteristics

Tranexamic Acid in Off-pump Coronary Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tranexamic Acid Group n=130 Participants Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.	Control Group n=130 Participants The placebo consisted of an equivalent volume of saline solution.	Total n=260 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	86 Participants n=93 Participants	89 Participants n=4 Participants	175 Participants n=27 Participants
Age, Categorical >=65 years	44 Participants n=93 Participants	41 Participants n=4 Participants	85 Participants n=27 Participants
Age Continuous	60.5 years STANDARD_DEVIATION 8.0 • n=93 Participants	60 years STANDARD_DEVIATION 8.5 • n=4 Participants	60.4 years STANDARD_DEVIATION 8.5 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	16 Participants n=4 Participants	42 Participants n=27 Participants
Sex: Female, Male Male	104 Participants n=93 Participants	114 Participants n=4 Participants	218 Participants n=27 Participants
Region of Enrollment China	130 participants n=93 Participants	130 participants n=4 Participants	260 participants n=27 Participants

PRIMARY outcome

Timeframe: 1month postoperative

Population: As predefined by study protocol,Fourteen patients in the tranexamic acid group and Fifteen in the placebo group were withdrawn from the study due to conversion to on-pump surgery during the course of surgery.

Outcome measures

Outcome measures
Measure	Tranexamic Acid Group n=116 Participants Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.	Control Group n=115 Participants The placebo consisted of an equivalent volume of saline solution.
Number of Patients Required Allogenic Red Blood Cells Transfusion	37 participants	54 participants

SECONDARY outcome

Timeframe: 24h postoperative

Outcome measures

Outcome measures
Measure	Tranexamic Acid Group n=116 Participants Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.	Control Group n=115 Participants The placebo consisted of an equivalent volume of saline solution.
Postoperative Chest Tube Drainage	654 ml Standard Deviation 224	891 ml Standard Deviation 295

Adverse Events

Tranexamic Acid Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Guyan Wang

Cardiovascular Institute & Fuwai Hospital

Phone: 86-10-88398377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place