Trial Outcomes & Findings for Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty (NCT NCT02664909)

NCT ID: NCT02664909

Last Updated: 2021-07-22

Results Overview

The rate of transfusion will be calculated for each study group.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)
• Results posted on: 2021-07-22

Participant Flow

Participant milestones

Measure	Tranexamic Acid Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Overall Study STARTED	17	19
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Topical (Intra-Articular) Tranexamic Acid and Transfusion Rates Following Hip Hemiarthroplasty

Baseline characteristics by cohort

Measure	Tranexamic Acid n=17 Participants Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 Participants Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)	Total n=36 Participants Total of all reporting groups
Age, Continuous	83 years STANDARD_DEVIATION 8.6 • n=5 Participants	83 years STANDARD_DEVIATION 9.6 • n=7 Participants	83 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	19 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: From the time of surgery until 2-4 days post-operative (length of inpatient hospital stay)

The rate of transfusion will be calculated for each study group.

Outcome measures

Measure	Tranexamic Acid n=17 Participants Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 Participants Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Number of Participants Who Needed Transfusions	0 Participants	5 Participants

SECONDARY outcome

Timeframe: 2-4 days post-operative (length of inpatient hospital stay)

The transfusion amount will be calculated for each study group.

Outcome measures

Measure	Tranexamic Acid n=17 Participants Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 Participants Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Inpatient Transfusion Amount	NA unit of blood (250 cc) Standard Deviation NA No patient received transfusions	1.2 unit of blood (250 cc) Standard Deviation 0.45

SECONDARY outcome

Timeframe: Pre-operative hemoglobin level vs. post-operative day 1 hemoglobin level

Outcome measures

Measure	Tranexamic Acid n=17 Participants Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 Participants Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Difference Between Pre/Post-operative Hemoglobin	1.45 grams per deciliter Interval 1.1 to 1.81	1.48 grams per deciliter Interval 0.71 to 2.25

SECONDARY outcome

Timeframe: Pre-operative hematocrit level vs. post-operative day 1 hematocrit level

Outcome measures

Measure	Tranexamic Acid n=17 Participants Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 Participants Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Difference Between Pre/Post-operative Hematocrit	4.1 percent of blood that is red blood cells Interval 2.98 to 5.17	4.4 percent of blood that is red blood cells Interval 2.18 to 6.56

SECONDARY outcome

Timeframe: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever comes first, assessed up to 42 days post-operatively

Outcome measures

Measure	Tranexamic Acid n=17 Participants Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 Participants Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Length of Inpatient Hospital Stay	3.9 days Standard Deviation 1.1	4.8 days Standard Deviation 1.9

SECONDARY outcome

Timeframe: Admission to second post-operative visit (4-6 weeks post-operative)

Outcome measures

Measure	Tranexamic Acid n=17 Participants Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 Participants Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Number of Participants With Post-operative Complications	6 Participants	11 Participants

SECONDARY outcome

Timeframe: Collected 4-6 weeks post-operative

Population: Data was not gathered for this outcome measure and therefore never analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Tranexamic Acid

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tranexamic Acid n=17 participants at risk Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 participants at risk Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Cardiac disorders inpatient treatment for myocardial infarction	0.00% 0/17 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Cardiac disorders demand ischemia	0.00% 0/17 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Renal and urinary disorders acute kidney injury	5.9% 1/17 • Number of events 1 • 6 weeks	0.00% 0/19 • 6 weeks

Other adverse events

Measure	Tranexamic Acid n=17 participants at risk Patients will receive 1 gram of topically applied tranexamic acid into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. 1 gram of tranexamic acid will be mixed with normal saline to a total volume of 50 cc, half of which will be delivered intra-articularly and half of which will be delivered in the subfascial space. Tranexamic Acid	Placebo n=19 participants at risk Patients will receive 50 cc of topically applied normal saline into their surgical wound at the time of wound closure during their hip hemiarthroplasty surgery. Half of this 50 cc dose of normal saline will be delivered intra-articularly and half will be delivered in the subfascial space. Placebo (saline)
Musculoskeletal and connective tissue disorders 1 readmission for a fall with a contralateral hip fracture	5.9% 1/17 • Number of events 1 • 6 weeks	0.00% 0/19 • 6 weeks
Vascular disorders venous thrombosis	5.9% 1/17 • Number of events 1 • 6 weeks	0.00% 0/19 • 6 weeks
Gastrointestinal disorders ileus	5.9% 1/17 • Number of events 1 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Respiratory, thoracic and mediastinal disorders atelectasis	5.9% 1/17 • Number of events 1 • 6 weeks	0.00% 0/19 • 6 weeks
Psychiatric disorders altered mental state	0.00% 0/17 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Cardiac disorders syncope	0.00% 0/17 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Cardiac disorders hypertension	5.9% 1/17 • Number of events 1 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Psychiatric disorders agitation	0.00% 0/17 • 6 weeks	10.5% 2/19 • Number of events 2 • 6 weeks
Renal and urinary disorders urinary retention	0.00% 0/17 • 6 weeks	10.5% 2/19 • Number of events 2 • 6 weeks
Gastrointestinal disorders vomiting	11.8% 2/17 • Number of events 2 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
General disorders fever	17.6% 3/17 • Number of events 3 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.00% 0/17 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Renal and urinary disorders urinary tract infection	0.00% 0/17 • 6 weeks	5.3% 1/19 • Number of events 1 • 6 weeks
Renal and urinary disorders foley catheter	5.9% 1/17 • Number of events 1 • 6 weeks	10.5% 2/19 • Number of events 2 • 6 weeks

Additional Information

Vincent Williams, M.D.

UConn Health

Phone: (860) 679-8384

Email: vwilliams@uchc.edu

Results disclosure agreements

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