Trial Outcomes & Findings for Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery? (NCT NCT01714336)

NCT ID: NCT01714336

Last Updated: 2018-11-14

Results Overview

Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 138 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2018-11-14

Participant Flow

Participant milestones

Measure	Placebo Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Overall Study STARTED	69	69
Overall Study COMPLETED	69	69
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Tranexamic Acid Reduce the Need for Blood Transfusions in Patients Undergoing Hip Fracture Surgery?

Baseline characteristics by cohort

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.	Total n=138 Participants Total of all reporting groups
Age, Continuous	82.2 years STANDARD_DEVIATION 10 • n=5 Participants	81.0 years STANDARD_DEVIATION 10 • n=7 Participants	81.6 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	48 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants	69 participants n=7 Participants	138 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Proportion of patients transfused at least 1 unit of packed red blood cells during hospital admission

Outcome measures

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Number of Participants Who Received a Hospitalization Transfusion	18 participants	12 participants

SECONDARY outcome

Timeframe: 5 days

Mean number of units transfused per patient

Outcome measures

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Mean Number of Units Transfused	1.8 units/participant transfused Standard Deviation 0.9	1.2 units/participant transfused Standard Deviation 0.5

SECONDARY outcome

Timeframe: 5 days

Calculated blood loss

Outcome measures

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Calculated Blood Loss	1214 cc Standard Deviation 540	902 cc Standard Deviation 439

SECONDARY outcome

Timeframe: Within 6 months of surgery

Incidence of symptomatic VTE diagnosed within 6 months of surgery

Outcome measures

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Number of Participants With Venous Thromboembolism (VTE) Diagnosis	2 participants	3 participants

SECONDARY outcome

Timeframe: Within 6 months of surgery

Wound complications diagnosed within 6 months of surgery

Outcome measures

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Number of Participants With Wound Complications	2 participants	5 participants

SECONDARY outcome

Timeframe: Within 6 months of surgery

MI diagnosed within 6 months of surgery

Outcome measures

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Number of Participants With Myocardial Infarction (MI) Diagnosis	3 participants	2 participants

SECONDARY outcome

Timeframe: Within 6 months of surgery

CVA diagnosed within 6 months of surgery

Outcome measures

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Number of Participants With Cerebrovascular Accident (CVA) Diagnosis	0 participants	1 participants

SECONDARY outcome

Timeframe: 6 months after surgery

All-cause mortality at 6 months

Outcome measures

Measure	Placebo n=69 Participants Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 Participants Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Number of Participants Who Died	11 participants	10 participants

Adverse Events

Placebo

Serious events: 15 serious events

Other events: 9 other events

Deaths: 0 deaths

Tranexamic Acid

Serious events: 14 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=69 participants at risk Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 participants at risk Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Cardiac disorders MI	4.3% 3/69 • Number of events 3	2.9% 2/69 • Number of events 2
Nervous system disorders CVA	0.00% 0/69	1.4% 1/69 • Number of events 1
Surgical and medical procedures Death	8.7% 6/69 • Number of events 6	10.1% 7/69 • Number of events 7
Blood and lymphatic system disorders VTE	8.7% 6/69 • Number of events 6	7.2% 5/69 • Number of events 5

Other adverse events

Measure	Placebo n=69 participants at risk Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.	Tranexamic Acid n=69 participants at risk Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure. tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
Surgical and medical procedures Readmission	13.0% 9/69 • Number of events 9	21.7% 15/69 • Number of events 15

Additional Information

Dr. Mark Pagnano

Mayo Clinic

Phone: 507-284-2511

Email: pagnano.mark@mayo.edu

Results disclosure agreements

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