Trial Outcomes & Findings for Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (NCT NCT03376061)

NCT ID: NCT03376061

Last Updated: 2021-02-11

Results Overview

Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 97 participants
• Primary outcome timeframe: Fluid collected in the first 24 hours after the surgical procedure
• Results posted on: 2021-02-11

Participant Flow

Between December 2017 and April 2018 a total of 97 patients were randomized to the topical (n = 49) and intravenous (n = 48) groups.

Participant milestones

Measure	Topical TxA (Intervention) 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Overall Study STARTED	49	48
Overall Study COMPLETED	49	48
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

Baseline characteristics by cohort

Measure	Topical TxA (Intervention) n=49 Participants 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients will receive intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) n=48 Participants Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.	Total n=97 Participants Total of all reporting groups
Age, Continuous	67.3 years STANDARD_DEVIATION 9.4 • n=5 Participants	67.8 years STANDARD_DEVIATION 9.2 • n=7 Participants	67.5 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	42 Participants n=7 Participants	86 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	46 Participants n=5 Participants	46 Participants n=7 Participants	92 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Southeast Asian/Malaysian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Aboriginal/Native Persons	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Canada	49 participants n=5 Participants	48 participants n=7 Participants	97 participants n=5 Participants
Diabetes mellitus	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Stroke	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Transient ischemic attack	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Carotid endarterectomy/stent	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
History of seizures	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
New oral anticoagulants (NOAC)	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Aspirin	38 Participants n=5 Participants	42 Participants n=7 Participants	80 Participants n=5 Participants
Clopidogrel (Plavix)	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Ticagrelor	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Fluid collected in the first 24 hours after the surgical procedure

Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure

Outcome measures

Measure	Topical TxA (Intervention) n=49 Participants 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) n=48 Participants Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Median Volume of Mediastinal Fluid Collected From Participants	500 mL Interval 350.0 to 750.0	540 mL Interval 420.0 to 700.0

SECONDARY outcome

Timeframe: Patients will be followed post-operatively until hospital discharge

Patients experiencing a post-operative seizure

Outcome measures

Measure	Topical TxA (Intervention) n=49 Participants 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) n=48 Participants Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Number of Participants With Seizures	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Patients will be followed post-operatively until hospital discharge

The occurrence of death due to any cause

Outcome measures

Measure	Topical TxA (Intervention) n=49 Participants 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) n=48 Participants Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Number of Participants With Mortality	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Intra-operative and post-operative RBC transfusions

Patients requiring a red blood cell transfusion

Outcome measures

Measure	Topical TxA (Intervention) n=49 Participants 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) n=48 Participants Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Number of Participants With RBC Transfusion	19 Participants	23 Participants

SECONDARY outcome

Timeframe: Patients will be followed post-operatively until hospital discharge

Occurrence of re-operation for the purpose of bleeding or cardiac tamponade

Outcome measures

Measure	Topical TxA (Intervention) n=49 Participants 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) n=48 Participants Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Number of Participants With Re-operation for Bleeding or Tamponade	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).

Number of hours participants spent in the intensive care unit (ICU)

Outcome measures

Measure	Topical TxA (Intervention) n=49 Participants 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) n=48 Participants Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Median Number of Hours Participants Spent in ICU	23 hours Interval 19.0 to 45.0	26 hours Interval 22.0 to 53.0

SECONDARY outcome

Timeframe: on arrival in ICU within 3 hours

Population: 4 patients from the topical TxA group and 3 patients from the intravenous TxA group were excluded because they either did not receive a TxA dose or received an incomplete TxA dose.

Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU

Outcome measures

Measure	Topical TxA (Intervention) n=45 Participants 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.	Intravenous TxA (Control) n=45 Participants Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Mean Concentration of TxA in Plasma Collected From Participants	0.58 microgram per milliliter per kilogram Standard Deviation 0.41	1.10 microgram per milliliter per kilogram Standard Deviation 0.52

Adverse Events

Topical TxA (Intervention)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Intravenous TxA (Control)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research assistant

Population Health Research Institute

Phone: 19055212100

Email: Austin.Browne@phri.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place