Trial Outcomes & Findings for Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population (NCT NCT03923959)

NCT ID: NCT03923959

Last Updated: 2024-10-10

Results Overview

Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 283 participants
• Primary outcome timeframe: 3 Months
• Results posted on: 2024-10-10

Participant Flow

One participant was enrolled twice for separate hip fractures, so one of the enrollments was removed.

Participant milestones

Measure	Intervention 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution	Placebo 100 cc normal saline Placebo: 100 cc normal saline
Overall Study STARTED	146	138
Overall Study COMPLETED	73	68
Overall Study NOT COMPLETED	73	70

Reasons for withdrawal

Measure	Intervention 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution	Placebo 100 cc normal saline Placebo: 100 cc normal saline
Overall Study Death	16	12
Overall Study Lost to Follow-up	56	56
Overall Study Withdrawal by Subject	1	1
Overall Study Participant enrolled twice for separate hip fractures - one enrollment removed.	0	1

Baseline Characteristics

Evaluation of TXA Prior to Surgery in the Geriatric Hip Fracture Population

Baseline characteristics by cohort

Measure	Intervention n=146 Participants 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution	Placebo n=137 Participants 100 cc normal saline Placebo: 100 cc normal saline	Total n=283 Participants Total of all reporting groups
Age, Continuous	88.2 years STANDARD_DEVIATION 11 • n=5 Participants	86.0 years STANDARD_DEVIATION 8.7 • n=7 Participants	87.2 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	106 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	31 Participants n=7 Participants	72 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=5 Participants	136 Participants n=7 Participants	280 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	142 Participants n=5 Participants	134 Participants n=7 Participants	276 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	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	146 participants n=5 Participants	137 participants n=7 Participants	283 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

Population: All participants who underwent treatment.

Count of participants with acute post-operative transfusion of packed red blood cells along with the corresponding 95% CI.

Outcome measures

Measure	Intervention n=146 Participants 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution. Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects	Placebo n=137 Participants 100 cc normal saline Placebo: 100 cc normal saline Includes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects
Count of Participants With Acute Post-operative Transfusion of Packed Red Blood Cells.	118 Participants	111 Participants

SECONDARY outcome

Timeframe: 3 Months

Determine if participants randomized to TXA experienced increased risk of complications compared to placebo. Complications include number of deep vein thrombosis events, pulmonary emboli events, myocardial infarction events, and cerebral vascular events within 12 weeks post hip fracture surgery.

Outcome measures

Measure	Intervention n=146 Participants 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution. Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects	Placebo n=137 Participants 100 cc normal saline Placebo: 100 cc normal saline Includes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects
Complication Rate	43 Participants	30 Participants

SECONDARY outcome

Timeframe: 30 Days

Determine differences between the groups in 30 day readmission rates.

Outcome measures

Measure	Intervention n=146 Participants 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution. Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects	Placebo n=137 Participants 100 cc normal saline Placebo: 100 cc normal saline Includes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects
Hospital Readmission	11 Participants	8 Participants

SECONDARY outcome

Timeframe: 90 Days

Death within 90 days post hip surgery

Outcome measures

Measure	Intervention n=146 Participants 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution. Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects	Placebo n=137 Participants 100 cc normal saline Placebo: 100 cc normal saline Includes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects
Mortality Rate	15 Participants	11 Participants

SECONDARY outcome

Timeframe: From date of study intervention/surgery for hip fracture until the date of discharge or date of death from any cause, whichever came first, assessed up to 34 months.

Length of stay immediately post study intervention/surgery for hip fracture

Outcome measures

Measure	Intervention n=146 Participants 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution. Includes administration of pre-operative intravenous tranexamic acid and saline for surgical geriatric hip fracture subjects	Placebo n=137 Participants 100 cc normal saline Placebo: 100 cc normal saline Includes administration of pre-operative intravenous saline for surgical geriatric hip fracture subjects
Length of Stay	5 days Standard Deviation 4.1	4.8 days Standard Deviation 3.8

Adverse Events

Intervention

Serious events: 3 serious events

Other events: 69 other events

Deaths: 16 deaths

Placebo

Serious events: 1 serious events

Other events: 57 other events

Deaths: 12 deaths

Serious adverse events

Measure	Intervention n=146 participants at risk 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution	Placebo n=137 participants at risk 100 cc normal saline Placebo: 100 cc normal saline
Endocrine disorders Hyperglycemia (worsening of condition -> death)	0.68% 1/146 • 3 months	0.00% 0/137 • 3 months
Vascular disorders Acute infarct in R parietal region (pt released on hospice)	0.68% 1/146 • 3 months	0.00% 0/137 • 3 months
Respiratory, thoracic and mediastinal disorders Post-operative respiratory failure with hypercarbia	0.68% 1/146 • 3 months	0.00% 0/137 • 3 months
General disorders Death	0.00% 0/146 • 3 months	0.73% 1/137 • 3 months

Other adverse events

Measure	Intervention n=146 participants at risk 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution	Placebo n=137 participants at risk 100 cc normal saline Placebo: 100 cc normal saline
General disorders Moderate	17.1% 25/146 • 3 months	13.9% 19/137 • 3 months
General disorders Mild	30.1% 44/146 • 3 months	27.7% 38/137 • 3 months

Additional Information

Halle Becker

LancasterGH

Phone: 7175441401

Email: halle.becker@pennmedicine.upenn.edu

Results disclosure agreements

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