Trial Outcomes & Findings for Hemostasis in Open Acetabulum and Pelvic Ring Surgery Using Tranexamic Acid (NCT NCT02051686)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

Day of Surgery

Results posted on

2018-02-27

Participant milestones
Measure	Tranexamic Acid Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours. Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.	Placebo The control group will receive a similar volume load of normal saline and maintenance doses. Placebo: The control group will receive a similar volume load of normal saline and maintenance doses.
Overall Study STARTED	42	46
Overall Study COMPLETED	42	46
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Tranexamic Acid n=42 Participants Patients in the intervention group were administered a 10mg/kg preoperative dose of tranexamic acid within 30 minutes prior to surgery followed by a 10mg/kg infusion over a 4hr period during surgery.	Placebo n=46 Participants Patients in the control group received an equal volume and rate of normal saline.	Total n=88 Participants Total of all reporting groups
Age, Continuous	41.7 years STANDARD_DEVIATION 15.6 • n=42 Participants	39.7 years STANDARD_DEVIATION 16.1 • n=46 Participants	40.7 years STANDARD_DEVIATION 15.9 • n=88 Participants
Sex: Female, Male Female	11 Participants n=42 Participants	12 Participants n=46 Participants	23 Participants n=88 Participants
Sex: Female, Male Male	31 Participants n=42 Participants	34 Participants n=46 Participants	65 Participants n=88 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	42 Participants n=42 Participants	46 Participants n=46 Participants	88 Participants n=88 Participants

Timeframe: Day of Surgery

Outcome measures
Measure	Tranexamic Acid n=42 Participants Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours. Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.	Placebo n=46 Participants The control group will receive a similar volume load of normal saline and maintenance doses. Placebo: The control group will receive a similar volume load of normal saline and maintenance doses.
Intra-operative Blood Loss	727.6 Milliliters Standard Deviation 702.52	560.1 Milliliters Standard Deviation 378.4

Timeframe: Perioperative (hospitalized period)

Outcome measures
Measure	Tranexamic Acid n=42 Participants Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours. Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.	Placebo n=46 Participants The control group will receive a similar volume load of normal saline and maintenance doses. Placebo: The control group will receive a similar volume load of normal saline and maintenance doses.
Number of Participants That Required an Allogenic Transfusion	21 Participants	15 Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events
Measure	Tranexamic Acid n=42 participants at risk Group I will receive 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours. Tranexamic Acid: 10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.	Placebo n=46 participants at risk The control group will receive a similar volume load of normal saline and maintenance doses. Placebo: The control group will receive a similar volume load of normal saline and maintenance doses.
Blood and lymphatic system disorders Venous thromboembolism	2.4% 1/42 • 1 year	0.00% 0/46 • 1 year

Adverse event data not reported

University of Missouri, Department of Orthopaedics

Phone: 573-882-6562