Trial Outcomes & Findings for Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery (NCT NCT00958581)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

177 participants

Primary outcome timeframe

1 Week

Results posted on

2018-01-17

Participant Flow

Consenting completed at PI and co-investigators' private offices, clinic and in preoperative center. Study staff approved by the IRB consent the patients. First patient enrolled on 12/16/2008. Last patient enrolled on 9/17/2012.

Patients were excluded from the trial after enrollment if their surgery was cancelled.

Participant milestones

Participant milestones
Measure	Epsilon Aminocaproic Acid Patients will receive EACA before and during the surgical case. Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.	Normal Saline Patients infused with normal saline before and during the surgical procedure as a placebo. Normal Saline :	Tranexamic Acid Patients receive TXA before and during the surgical case. Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.
Overall Study STARTED	61	61	55
Overall Study COMPLETED	61	61	55
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epsilon Aminocaproic Acid n=61 Participants Patients will receive EACA before and during the surgical case. Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.	Normal Saline n=61 Participants Patients infused with normal saline before and during the surgical procedure as a placebo. Normal Saline :	Tranexamic Acid n=55 Participants Patients receive TXA before and during the surgical case. Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.	Total n=177 Participants Total of all reporting groups
Age, Categorical <=18 years	42 Participants n=5 Participants	47 Participants n=7 Participants	36 Participants n=5 Participants	125 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	38 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	39 Participants n=7 Participants	45 Participants n=5 Participants	134 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	22 Participants n=7 Participants	10 Participants n=5 Participants	43 Participants n=4 Participants
Region of Enrollment United States	61 Participants n=5 Participants	61 Participants n=7 Participants	55 Participants n=5 Participants	177 Participants n=4 Participants

PRIMARY outcome

Timeframe: 1 Week

Outcome measures

Outcome measures
Measure	Epsilon Aminocaproic Acid n=61 Participants Patients will receive EACA before and during the surgical case. Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.	Normal Saline n=61 Participants Patients infused with normal saline before and during the surgical procedure as a placebo. Normal Saline :	Tranexamic Acid n=55 Participants Patients receive TXA before and during the surgical case. Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.
Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)	1775 ml Standard Deviation 853	2116 ml Standard Deviation 1201	1531 ml Standard Deviation 911

SECONDARY outcome

Timeframe: 1 week

Population: Data for this outcome measure unattainable as PI and study team are no longer with the institution. This outcome measure data was not published in paper.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 week

Population: Data for this outcome measure unattainable as PI and study team are no longer with the institution. This outcome measure data was not published in paper.

Outcome measures

Outcome data not reported

Adverse Events

Epsilon Aminocaproic Acid

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Tranexamic Acid

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Epsilon Aminocaproic Acid n=61 participants at risk Patients will receive EACA before and during the surgical case. Epsilon aminocaproic acid : For EACA, the loading dose is 100mg/kg infused over 15 minutes, while the maintenance dose is 10mg/kg hr.	Normal Saline n=61 participants at risk Patients infused with normal saline before and during the surgical procedure as a placebo. Normal Saline :	Tranexamic Acid n=55 participants at risk Patients receive TXA before and during the surgical case. Tranexamic Acid : For TXA, the loading dose is 10mg/kg infused over 15 minutes, while the maintenance dose is 1/mg/kg hr.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.6% 1/61 • Number of events 1	1.6% 1/61 • Number of events 1	1.8% 1/55 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Thomas Errico (Chief of Spine), Dr. Kushagra Verma (Co-investigator)

NYU hospital for Joint Diseases

Phone: 212-598-6076

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place