Trial Outcomes & Findings for TXA Study in Major Oncologic Surgery (NCT NCT01980355)

NCT ID: NCT01980355

Last Updated: 2023-08-07

Results Overview

To determine the impact of perioperative administration of tranexamic acid on blood loss and transfusion rates in major oncologic surgery

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 76 participants
• Primary outcome timeframe: From time of surgery to 90 days post hospital discharge
• Results posted on: 2023-08-07

Participant Flow

Participant milestones

Measure	Tranexamic Acid 1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. Tranexamic Acid	Placebo Placebo given over 15 minutes into the vein once prior to surgery. Placebo
Overall Study STARTED	39	37
Overall Study COMPLETED	39	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Tranexamic Acid n=39 Participants 1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. Tranexamic Acid	Placebo n=37 Participants Placebo given over 15 minutes into the vein once prior to surgery. Placebo	Total n=76 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 11.9 • n=39 Participants	63.2 years STANDARD_DEVIATION 11.2 • n=37 Participants	61.1 years STANDARD_DEVIATION 11.3 • n=76 Participants
Sex: Female, Male Female	10 Participants n=39 Participants	7 Participants n=37 Participants	17 Participants n=76 Participants
Sex: Female, Male Male	29 Participants n=39 Participants	30 Participants n=37 Participants	59 Participants n=76 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From time of surgery to 90 days post hospital discharge

To determine the impact of perioperative administration of tranexamic acid on blood loss and transfusion rates in major oncologic surgery

Outcome measures

Measure	Tranexamic Acid n=39 Participants 1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. Tranexamic Acid	Placebo n=37 Participants Placebo given over 15 minutes into the vein once prior to surgery. Placebo
Number of Participants Who Required Transfusion	8 Participants	5 Participants

SECONDARY outcome

Timeframe: From time of surgery to 90 days post hospital discharge

Surgical blood loss estimation

Outcome measures

Measure	Tranexamic Acid n=39 Participants 1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. Tranexamic Acid	Placebo n=37 Participants Placebo given over 15 minutes into the vein once prior to surgery. Placebo
Estimated Blood Loss	450 mL Interval 250.0 to 750.0	365 mL Interval 150.0 to 850.0

Adverse Events

Tranexamic Acid

Serious events: 11 serious events

Other events: 0 other events

Deaths: 2 deaths

Placebo

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tranexamic Acid n=39 participants at risk 1000mg tranexamic acid; given over 15 minutes into the vein once prior to surgery. Tranexamic Acid	Placebo n=37 participants at risk Placebo given over 15 minutes into the vein once prior to surgery. Placebo
Surgical and medical procedures Surgical Morbidity	28.2% 11/39 • Number of events 11 • 90 days from the time of surgery Morbidity graded according to Clavien-Dindo classification	35.1% 13/37 • Number of events 13 • 90 days from the time of surgery Morbidity graded according to Clavien-Dindo classification

Other adverse events

Adverse event data not reported

Additional Information

G. Paul Wright, MD

Spectrum Health

Phone: 6162678540

Email: paul.wright@spectrumhealth.org

Results disclosure agreements

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