Trial Outcomes & Findings for The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO (NCT NCT02257580)

Results Overview

Determined by estimated blood volume, calculated using difference in preoperative and postoperative hemoglobin and applied to the Nadler equation for estimating blood volume while adjusting for transfused hemoglobin to produce a single metric of calculated intraoperative blood loss.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

28 participants

Primary outcome timeframe

Intraoperative (3-6 hours)

Results posted on

2022-11-23

Participant Flow

Patients aged 18 or younger with CP indicated for bilateral VRO. Hx of a thromboembolic event, renal insufficiency or failure, known hypersensitivity to EACA, congenital or acquired coagulopathy, pts that could not receive neuraxial anesthesia, being treated with anticoagulants, hormone replacement therapy or hormonal contraceptive agent were excluded. Pts undergoing bilateral VRO were identified and screened by the study surgeons. 2 screened pts declined to participate, 2 did not qualify.

Participant milestones

Participant milestones
Measure	E-Aminocaproic Acid (EACA) An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.	Placebo Equivalent volume of normal saline prepared by the pharmacy.
Overall Study STARTED	16	12
Overall Study COMPLETED	16	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	E-Aminocaproic Acid (EACA) n=16 Participants An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.	Placebo n=12 Participants Equivalent volume of normal saline prepared by the pharmacy.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=16 Participants	12 Participants n=12 Participants	28 Participants n=28 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=16 Participants	0 Participants n=12 Participants	0 Participants n=28 Participants
Age, Categorical >=65 years	0 Participants n=16 Participants	0 Participants n=12 Participants	0 Participants n=28 Participants
Sex: Female, Male Female	6 Participants n=16 Participants	4 Participants n=12 Participants	10 Participants n=28 Participants
Sex: Female, Male Male	10 Participants n=16 Participants	8 Participants n=12 Participants	18 Participants n=28 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	16 participants n=16 Participants	12 participants n=12 Participants	28 participants n=28 Participants

PRIMARY outcome

Timeframe: Intraoperative (3-6 hours)

Determined by estimated blood volume, calculated using difference in preoperative and postoperative hemoglobin and applied to the Nadler equation for estimating blood volume while adjusting for transfused hemoglobin to produce a single metric of calculated intraoperative blood loss.

Outcome measures

Outcome measures
Measure	E-Aminocaproic Acid (EACA) n=16 Participants An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.	Placebo n=12 Participants Equivalent volume of normal saline prepared by the pharmacy.
Intraoperative Calculated Total Blood Loss	535.7 mL Standard Deviation 356.6	628.0 mL Standard Deviation 235.8

SECONDARY outcome

Timeframe: Intraoperative, 1 day

Number of participants requiring 1 unit of intraoperative cell saver transfusion. Patients either received or did not receive intraoperative cell saver transfusion. The maximum number of intraoperative units transfused in this study was 1 unit. The count of participants in the data table refers to the number of patients who received this transfusion.

Outcome measures

Outcome measures
Measure	E-Aminocaproic Acid (EACA) n=16 Participants An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.	Placebo n=12 Participants Equivalent volume of normal saline prepared by the pharmacy.
Intraoperative Cell Saver Utilization	7 Participants	7 Participants

SECONDARY outcome

Timeframe: Post-Surgery, an expected average of 1 week

The number of participants that required 1 unit of blood transfused post-operatively. Patients received blood if necessary post operatively, and the maximum number of units a patient received was 1. The count of participants refers to the number of patients who received this transfusion unit.

Outcome measures

Outcome measures
Measure	E-Aminocaproic Acid (EACA) n=16 Participants An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.	Placebo n=12 Participants Equivalent volume of normal saline prepared by the pharmacy.
Postoperative Allogeneic Blood Transfusion	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Post-Surgery, 24 hours

24 hour drain output (mL)

Outcome measures

Outcome measures
Measure	E-Aminocaproic Acid (EACA) n=16 Participants An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.	Placebo n=12 Participants Equivalent volume of normal saline prepared by the pharmacy.
Post Operative Blood Loss	72.5 mL Standard Deviation 69.8	103.3 mL Standard Deviation 91.4

SECONDARY outcome

Timeframe: Post-Surgery, an expected average of 1 week

postoperative day of discharge after surgery- day of intake.

Outcome measures

Outcome measures
Measure	E-Aminocaproic Acid (EACA) n=16 Participants An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.	Placebo n=12 Participants Equivalent volume of normal saline prepared by the pharmacy.
Length of Hospital Stay	5.5 days Interval 4.0 to 7.0	5.1 days Interval 4.0 to 6.0

SECONDARY outcome

Timeframe: an expected average of 1 week (post-surgery), Follow-up at 6 weeks

Incidence of VTE (symptomatic of DVT or PE), infection (superficial, deep), hematoma, seroma, reoperation, and death, measured in person-years ( x cases per 100,000 person years)

Outcome measures

Outcome measures
Measure	E-Aminocaproic Acid (EACA) n=16 Participants An EACA loading dose of 100 mg/kg with a max of 4-5 grams will be given up to 1 hour prior to incision. During the case, an EACA infusion of 33 mg/kg/hr (max of 1 gram/hr) will be maintained. The use of EACA will be terminated at the end of the case.	Placebo n=12 Participants Equivalent volume of normal saline prepared by the pharmacy.
Complications [VTE (Symptomatic of DVT or PE), Infection (Superficial, Deep), Hematoma, Seroma, Reoperation, and Death]	0 cases per 100,000 person years	0 cases per 100,000 person years

Adverse Events

E-Aminocaproic Acid (EACA)

Serious events: 0 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

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Colson Zucker, Research Coordinator

Hospital for Special Surgery

Phone: 6467146029

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place