Trial Outcomes & Findings for The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery (NCT NCT02684851)

NCT ID: NCT02684851

Last Updated: 2022-04-21

Results Overview

Number of participant received allogenic blood transfusions.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 87 participants
• Primary outcome timeframe: post-operative
• Results posted on: 2022-04-21

Participant Flow

Participant milestones

Measure	Placebo Inactive Placebo: Placebo	Tranexamic Tranexamic acid: anti-fibrinolytic agents Tranexamic Acid: Tranexamic acid: anti-fibrinolytic agents
Overall Study STARTED	42	45
Overall Study COMPLETED	42	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of Tranexamic Acid to Reduce Blood Loss in Acetabular Surgery

Baseline characteristics by cohort

Measure	Placebo n=42 Participants Inactive Placebo: Placebo	Tranexamic n=45 Participants Tranexamic acid: anti-fibrinolytic agents Tranexamic Acid: Tranexamic acid: anti-fibrinolytic agents	Total n=87 Participants Total of all reporting groups
Age, Customized	43.7 Years STANDARD_DEVIATION 13.5 • n=5 Participants	42.3 Years STANDARD_DEVIATION 16.2 • n=7 Participants	43.0 Years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
BMI	31.2 kg/m^2 STANDARD_DEVIATION 13.5 • n=5 Participants	32.1 kg/m^2 STANDARD_DEVIATION 16.2 • n=7 Participants	31.7 kg/m^2 STANDARD_DEVIATION 14.7 • n=5 Participants
Co-morbidities Cardiac Disease	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Co-morbidities Diabetes	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Surgical approach Posterior Approach	37 Participants n=5 Participants	35 Participants n=7 Participants	72 Participants n=5 Participants
Surgical approach Anterior Approach	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Surgical approach Combined Anterior/Posterior	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Operative time in minutes	239.4 Minutes STANDARD_DEVIATION 100.6 • n=5 Participants	209.9 Minutes STANDARD_DEVIATION 72.3 • n=7 Participants	224.7 Minutes STANDARD_DEVIATION 86.6 • n=5 Participants
Preoperative Hemoglobin in g/dl	11.1 g/dl STANDARD_DEVIATION 2.26 • n=5 Participants	11.9 g/dl STANDARD_DEVIATION 2.19 • n=7 Participants	11.5 g/dl STANDARD_DEVIATION 2.23 • n=5 Participants
Letournel Fracture Classification Associated Fractures	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants
Letournel Fracture Classification Elementary Fractures	20 Participants n=5 Participants	28 Participants n=7 Participants	48 Participants n=5 Participants
Orthopaedic Trauma Association Fracture Classification Pelvis, acetabulum, partial articular, isolated column and/or wall fracture (62A)	22 Participants n=5 Participants	28 Participants n=7 Participants	50 Participants n=5 Participants
Orthopaedic Trauma Association Fracture Classification Pelvis, acetabulum, partial articular, transverse type fracture (62B)	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Orthopaedic Trauma Association Fracture Classification Pelvis, acetabulum, complete articular, associated both column fracture (62C)	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: post-operative

Number of participant received allogenic blood transfusions.

Outcome measures

Measure	Tranexamic n=45 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 (for patients weighing over 100kg, a weight of 100kg was used for the dose calculation).	Placebo n=42 Participants Patients in the control group received an equal volume and rate of normal saline. Patients and providers were blinded with the aid of an investigational drug pharmacy.
Allogenic Blood Transfusion Rates	21 Participants	13 Participants

PRIMARY outcome

Timeframe: perioperative

Average units packed red blood cells transfused among participants

Outcome measures

Measure	Tranexamic n=45 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 (for patients weighing over 100kg, a weight of 100kg was used for the dose calculation).	Placebo n=42 Participants Patients in the control group received an equal volume and rate of normal saline. Patients and providers were blinded with the aid of an investigational drug pharmacy.
Units of Packed Red Blood Cells Transfused	2.65 Units of packed red blood cells Standard Deviation 1.27	2.36 Units of packed red blood cells Standard Deviation 0.81

SECONDARY outcome

Timeframe: 30 days

Do patients undergoing acetabular ORIF who receive tranexamic acid have a higher risk for thromboembolic events than patients who receive placebo?

Outcome measures

Measure	Tranexamic n=45 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 (for patients weighing over 100kg, a weight of 100kg was used for the dose calculation).	Placebo n=42 Participants Patients in the control group received an equal volume and rate of normal saline. Patients and providers were blinded with the aid of an investigational drug pharmacy.
Number of Participants With a Thromboembolic Event	1 Participants	0 Participants

SECONDARY outcome

Timeframe: perioperative

To measure average estimate perioperative blood loss

Outcome measures

Measure	Tranexamic n=45 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 (for patients weighing over 100kg, a weight of 100kg was used for the dose calculation).	Placebo n=42 Participants Patients in the control group received an equal volume and rate of normal saline. Patients and providers were blinded with the aid of an investigational drug pharmacy.
Estimate Blood Loss	727.6 mL Standard Deviation 702.52	560.1 mL Standard Deviation 378.4

Adverse Events

Tranexamic

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tranexamic n=45 participants at risk 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 (for patients weighing over 100kg, a weight of 100kg was used for the dose calculation).	Placebo n=42 participants at risk Patients in the control group received an equal volume and rate of normal saline. Patients and providers were blinded with the aid of an investigational drug pharmacy.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolus	2.2% 1/45 • Number of events 1 • 6 months	0.00% 0/42 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Rachel Seymour, PhD

CarolinasHS

Phone: 704-355-6969

Email: Rachel.Seymour@carolinashealthcare.org

Results disclosure agreements

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