Trial Outcomes & Findings for Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery (NCT NCT01519245)

NCT ID: NCT01519245

Last Updated: 2013-07-02

Results Overview

According to standard practice, research participants were be transferred to the intensive care unit (ICU) for post-operative monitoring. Measurement of chest tube output began immediately on arrival to the ICU. Hourly measurements were recorded. Data collection ended upon chest tube removal, or return to the operating room for exploratory surgery due to massive blood loss. As per ICU protocol, chest tubes were be removed when blood loss was recorded to be less than 200mL after six consecutive hours.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

44 participants

Primary outcome timeframe

From ICU admission post-operatively to mediastinal chest tube removal (placebo group = 20.6 hours; trial group = 19.8 hours)

Results posted on

2013-07-02

Participant Flow

All patients scheduled to undergo elective or urgent CABG at Royal University Hospital between December 1, 2011 and April 30, 2012 were screened for participation. Patients meeting inclusion criteria were approached by a study team member at the time of pre-admission clinic attendance or on the in-patient ward with an invitation to participate.

Patients meeting inclusion criteria were eligible for study participation. Randomization of consented participants took place by the Clinical Trials Pharmacy on the day of surgery, following confirmation of surgical procedure. The study team could withdraw consented patients prior to randomization and surgery if exclusion criteria were identified.

Participant milestones

Participant milestones
Measure	Trial Drug Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)	Placebo Normal saline (70mL)
Overall Study STARTED	24	20
Overall Study Received Pre-pump IV TXA	21	18
Overall Study Received Post-pump IV TXA	6	2
Overall Study COMPLETED	23	18
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Trial Drug Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)	Placebo Normal saline (70mL)
Overall Study Met exclusion criteria, not analysed	1	2

Baseline Characteristics

Topical Application of Tranexamic Acid to Reduce Post-operative Bleeding in Coronary Artery Bypass Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trial Drug n=23 Participants Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)	Placebo n=18 Participants Normal saline (70mL)	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Age Continuous	62 years STANDARD_DEVIATION 8.7 • n=5 Participants	62 years STANDARD_DEVIATION 10.4 • n=7 Participants	62 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Region of Enrollment Canada	23 participants n=5 Participants	18 participants n=7 Participants	41 participants n=5 Participants
Mass	92.7 kilograms STANDARD_DEVIATION 10.5 • n=5 Participants	91.3 kilograms STANDARD_DEVIATION 13.2 • n=7 Participants	92.2 kilograms STANDARD_DEVIATION 11.6 • n=5 Participants
Height	1.7 meters STANDARD_DEVIATION 0.1 • n=5 Participants	1.7 meters STANDARD_DEVIATION 0.1 • n=7 Participants	1.7 meters STANDARD_DEVIATION 0.1 • n=5 Participants
Body Mass Index	31.1 kg/m^2 STANDARD_DEVIATION 4.2 • n=5 Participants	31.2 kg/m^2 STANDARD_DEVIATION 5.1 • n=7 Participants	31.1 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants
Number of Bypasses	4.1 Number of vessels STANDARD_DEVIATION 1.0 • n=5 Participants	4.3 Number of vessels STANDARD_DEVIATION 1.1 • n=7 Participants	4.2 Number of vessels STANDARD_DEVIATION 1.1 • n=5 Participants
Pre-operative Antiplatelet Use Off 7 days or less	22 participants n=5 Participants	18 participants n=7 Participants	40 participants n=5 Participants
Pre-operative Antiplatelet Use Off more than 7 days	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Angina Yes	22 participants n=5 Participants	18 participants n=7 Participants	40 participants n=5 Participants
Angina No	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
History of Myocardial Infarction Yes	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
History of Myocardial Infarction No	14 participants n=5 Participants	9 participants n=7 Participants	23 participants n=5 Participants
Stent in situ Yes	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants
Stent in situ No	20 participants n=5 Participants	14 participants n=7 Participants	34 participants n=5 Participants
Diabetes Yes	9 participants n=5 Participants	7 participants n=7 Participants	16 participants n=5 Participants
Diabetes No	14 participants n=5 Participants	11 participants n=7 Participants	25 participants n=5 Participants
Dyslipidemia Yes	17 participants n=5 Participants	13 participants n=7 Participants	30 participants n=5 Participants
Dyslipidemia No	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants
Atrial Fibrillation Yes	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Atrial Fibrillation No	23 participants n=5 Participants	18 participants n=7 Participants	41 participants n=5 Participants
Hypertension Yes	18 participants n=5 Participants	14 participants n=7 Participants	32 participants n=5 Participants
Hypertension No	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants
Pre-operative Hemoglobin	147 g/L STANDARD_DEVIATION 13 • n=5 Participants	142 g/L STANDARD_DEVIATION 14 • n=7 Participants	145 g/L STANDARD_DEVIATION 14 • n=5 Participants
Pre-operative platelet count	242 platelets x 10^9/L STANDARD_DEVIATION 70 • n=5 Participants	234 platelets x 10^9/L STANDARD_DEVIATION 62 • n=7 Participants	239 platelets x 10^9/L STANDARD_DEVIATION 66 • n=5 Participants
Pre-operative white blood cell (WBC) count	7.7 WBC x 10^9/L STANDARD_DEVIATION 1.9 • n=5 Participants	7.9 WBC x 10^9/L STANDARD_DEVIATION 3.2 • n=7 Participants	7.8 WBC x 10^9/L STANDARD_DEVIATION 2.5 • n=5 Participants
Pre-operative International Normalized Ratio (INR)	1.0 International Normalized Ratio STANDARD_DEVIATION 0.1 • n=5 Participants	1.0 International Normalized Ratio STANDARD_DEVIATION 0.1 • n=7 Participants	1.0 International Normalized Ratio STANDARD_DEVIATION 0.1 • n=5 Participants
Pre-operative Creatinine	84 umol/L STANDARD_DEVIATION 25 • n=5 Participants	76 umol/L STANDARD_DEVIATION 18 • n=7 Participants	81 umol/L STANDARD_DEVIATION 23 • n=5 Participants

PRIMARY outcome

Timeframe: From ICU admission post-operatively to mediastinal chest tube removal (placebo group = 20.6 hours; trial group = 19.8 hours)

Population: A total of 44 consented participants were randomized. Prior to unblinding, 3 of the randomized participants were withdrawn from the study due to discovery of ineligibility criteria (1 EF \<50%, 1 weight \<75kg, 1 CABG x 7). Therefore, a total 41 patients were included in final analysis.

Outcome measures

Outcome measures
Measure	Trial Drug n=23 Participants Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL) Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)	Placebo n=18 Participants Normal saline (70mL) Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)
Total Volume of Blood Loss From Mediastinal Chest Tubes at Time of Removal (Assuming the Total Volume of Loss is Blood).	632 mL Standard Deviation 265	789 mL Standard Deviation 216

PRIMARY outcome

Timeframe: From ICU admission to transfer to the Cardiology Ward (placebo group = 24.4 hours; trial group = 24.7 hours)

Population: None of the research participants received PRBC transfusion postoperatively in the ICU.

Research participants were to receive a blood transfusion in the Intensive Care Unit (ICU) post-operatively if hemoglobin reached a nadir of 80g/L, or at the discretion of the intensivist or cardiac surgeon according to patient clinical status. Transfusion was quantified based on the number of units of PRBC received. (1 unit = 1 bag of blood, as prepared by Canadian Blood Services). Clinical status of research participants was followed throughout their duration in the ICU only. Participation in this study ended upon transfer out of the ICU, to the Cardiology Ward.

Outcome measures

Outcome measures
Measure	Trial Drug n=23 Participants Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL) Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)	Placebo n=18 Participants Normal saline (70mL) Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)
Number of Units of Packed Red Blood Cells (PRBC) Transfused Following Coronary Artery Bypass Graft Surgery	0 Unit(s) of PRBC	0 Unit(s) of PRBC

SECONDARY outcome

Timeframe: 6 hours following admission to the Intensive Care Unit

Volume of chest tube loss at 6 hours (assuming the total volume of loss is blood).

Outcome measures

Outcome measures
Measure	Trial Drug n=23 Participants Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL) Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)	Placebo n=18 Participants Normal saline (70mL) Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)
Volume of Blood Loss at 6 Hours	342 mL Standard Deviation 191	417 mL Standard Deviation 163

SECONDARY outcome

Timeframe: 12 hours following admission to the Intensive Care Unit

Volume of chest tube loss at 12 hours (assuming the total volume of loss is blood).

Outcome measures

Outcome measures
Measure	Trial Drug n=23 Participants Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL) Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)	Placebo n=18 Participants Normal saline (70mL) Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)
Volume of Blood Loss After 12 Hours	464 mL Standard Deviation 222	570 mL Standard Deviation 157

Adverse Events

Trial Drug

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Kelsey Brose, Primary Investigator

University of Saskatchewan

Phone: 306-655-1483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place