Trial Outcomes & Findings for Role of Topical Tranexamic Acid in Total Hip Arthroplasty (NCT NCT01866943)

Results Overview

Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Pre Op, Post Op Day 2

Results posted on

2018-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed. Normal Saline Solution	Group 2 Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed. Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.
Overall Study STARTED	19	22
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	19	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data are only available for the population overall since data were blinded and de-identified and it is not possible to determine what study subjects belong to which group. Further, since the study was terminated, no analysis was performed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=41 Participants Baseline population, Groups are as follows: Group 1 (Normal Saline Solution) Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed. Group 2 (Tranexamic Acid) Patients undergo primary total hip arthroplasty and have a wash of 100cc of normal saline plus 1.5 g (100 mg/mL)Tranexamic Acid is applied to the tissues under the skin prior to skin closure. The wash sits in the wound for 5 minutes then is suctioned out and the skin is closed. Tranexamic Acid: Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug. Since only blinded and deidentified data is available, Baseline measures will be reported on the entire population.
Age, Categorical <=18 years	0 Participants n=5 Participants • Data are only available for the population overall since data were blinded and de-identified and it is not possible to determine what study subjects belong to which group. Further, since the study was terminated, no analysis was performed.
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants • Data are only available for the population overall since data were blinded and de-identified and it is not possible to determine what study subjects belong to which group. Further, since the study was terminated, no analysis was performed.
Age, Categorical >=65 years	12 Participants n=5 Participants • Data are only available for the population overall since data were blinded and de-identified and it is not possible to determine what study subjects belong to which group. Further, since the study was terminated, no analysis was performed.
Age, Continuous	59.6 Years STANDARD_DEVIATION 9.44 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre Op, Post Op Day 2

Population: Patients undergoing primary unilateral THA. Group membership is unknown as only data available is blinded and de-identified.

Estimated Blood Loss defined as Pre Op Hgb mins the Post Op Day two Hgb.

Outcome measures

Outcome measures
Measure	Baseline Population n=12 Participants Data for 12 subjects is available, and cannot determine between groups as only data available is de-identified and blinded. Reporting data for these 12 subjects.
Estimated Blood Loss	2.93 Hemoglobin (grams/deciliter) Standard Deviation .77

SECONDARY outcome

Timeframe: Pre Op

Population: Patients undergoing primary unilateral THA.

Measurement of the thigh at the half way point between the prominence of the greater trochanter and the lateral epicondyle of the femur. No data recorded at 2 weeks or 6 weeks for this study population.

Outcome measures

Outcome measures
Measure	Baseline Population n=16 Participants Data for 12 subjects is available, and cannot determine between groups as only data available is de-identified and blinded. Reporting data for these 12 subjects.
Mid Thigh Circumference	52.99 centimeters Standard Deviation 6.32

SECONDARY outcome

Timeframe: Preoperative

Population: Patients undergoing primary total hip arthroplasty.

Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.

Outcome measures

Outcome measures
Measure	Baseline Population n=4 Participants Data for 12 subjects is available, and cannot determine between groups as only data available is de-identified and blinded. Reporting data for these 12 subjects.
Harris Hip Scores	58.34 units on a scale Standard Deviation 17.66

SECONDARY outcome

Timeframe: 2 week

Population: Patients undergoing primary total hip arthroplasty.

Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.

Outcome measures

Outcome measures
Measure	Baseline Population n=35 Participants Data for 12 subjects is available, and cannot determine between groups as only data available is de-identified and blinded. Reporting data for these 12 subjects.
Harris Hip Scores	65.76 units on a scale Standard Deviation 20.80

SECONDARY outcome

Timeframe: 6 week

Population: Patients undergoing primary total hip arthroplasty.

Standardized questionnaire that measures clinical function related to the hip. Total potential range is from 4.0 - 96.0. A higher score indicates a more favorable clinical outcome.

Outcome measures

Outcome measures
Measure	Baseline Population n=31 Participants Data for 12 subjects is available, and cannot determine between groups as only data available is de-identified and blinded. Reporting data for these 12 subjects.
Harris Hip Scores	81.77 units on a scale Standard Deviation 16.28

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Fellow

Hospital for Special Surgery

Phone: 917-843-6655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place