aminocaproic acid and Scoliosis studies

Aminocaproic Acid: An antifibrinolytic agent that acts by inhibiting plasminogen activators which have fibrinolytic properties.
6-aminohexanoic acid : An epsilon-amino acid comprising hexanoic acid carrying an amino substituent at position C-6. Used to control postoperative bleeding, and to treat overdose effects of the thrombolytic agents streptokinase and tissue plasminogen activator.

Scoliosis: An appreciable lateral deviation in the normally straight vertical line of the spine. (Dorland, 27th ed)

Research Excerpts

Excerpt	Relevance	Reference
"Prospective evaluation of fibrinogen levels before surgery and after surgery in patients with idiopathic scoliosis undergoing posterior spinal fusion (PSF) and segmental spinal instrumentation (SSI) who received Amicar to decrease perioperative blood loss."	7.74	Fibrinogen levels following Amicar in surgery for idiopathic scoliosis. ( Armstrong, DG; Florentino-Pineda, I; Poe-Kochert, C; Thompson, GH, 2007)
"A prospective study evaluating the efficacy of epsilon-aminocaproic acid (EACA) in decreasing perioperative blood loss in idiopathic scoliosis."	7.71	The Effect of epsilon-aminocaproic acid on perioperative blood loss in patients with idiopathic scoliosis undergoing posterior spinal fusion: a preliminary prospective study. ( Adler, P; Blakemore, LC; Florentino-Pineda, I; Poe-Kochert, C; Thompson, GH; Tripi, P, 2001)
"The purpose of this study was to determine if a higher dosing of ε-aminocaproic acid (EACA) is associated with less perioperative blood loss than a lower dose."	5.51	Unexpected higher blood loss associated with higher dose ε-aminocaproic acid in pediatric scoliosis surgery. ( Austin, T; Lam, H; Martus, J; Nguyen, T; Schoenecker, J, 2019)
" The primary aim of this study was to determine the efficacy of intraoperative tranexamic acid, epsilon-aminocaproic acid, and placebo at reducing perioperative blood loss and the transfusion rate in patients with adolescent idiopathic scoliosis undergoing posterior spinal arthrodesis."	5.19	The relative efficacy of antifibrinolytics in adolescent idiopathic scoliosis: a prospective randomized trial. ( Boenigk, K; Diefenbach, C; Dryer, J; Errico, T; Hoelscher, C; Huncke, T; Lonner, BS; Peters, A; Verma, K, 2014)
"A prospective, randomized, double-blind Institutional Review Board-approved study evaluating the efficacy of Amicar (epsilon aminocaproic acid), an antifibrinolytic agent, in decreasing perioperative blood loss in idiopathic scoliosis."	5.11	The effect of amicar on perioperative blood loss in idiopathic scoliosis: the results of a prospective, randomized double-blind study. ( Blakemore, LC; Florentino-Pineda, I; Haber, LL; Huang, RP; Poe-Kochert, C; Thompson, GH, 2004)
"Prospective evaluation of fibrinogen levels before surgery and after surgery in patients with idiopathic scoliosis undergoing posterior spinal fusion (PSF) and segmental spinal instrumentation (SSI) who received Amicar to decrease perioperative blood loss."	3.74	Fibrinogen levels following Amicar in surgery for idiopathic scoliosis. ( Armstrong, DG; Florentino-Pineda, I; Poe-Kochert, C; Thompson, GH, 2007)
"A prospective study evaluating the efficacy of epsilon-aminocaproic acid (EACA) in decreasing perioperative blood loss in idiopathic scoliosis."	3.71	The Effect of epsilon-aminocaproic acid on perioperative blood loss in patients with idiopathic scoliosis undergoing posterior spinal fusion: a preliminary prospective study. ( Adler, P; Blakemore, LC; Florentino-Pineda, I; Poe-Kochert, C; Thompson, GH; Tripi, P, 2001)
"The purpose of this study was to determine if a higher dosing of ε-aminocaproic acid (EACA) is associated with less perioperative blood loss than a lower dose."	1.51	Unexpected higher blood loss associated with higher dose ε-aminocaproic acid in pediatric scoliosis surgery. ( Austin, T; Lam, H; Martus, J; Nguyen, T; Schoenecker, J, 2019)
"Tranexamic acid (TXA) was found to be more effective at reducing total blood loss compared with epsilon-aminocaproic acid (AM) than placebo."	1.48	Antifibrinolytic Therapy in Surgery for Adolescent Idiopathic Scoliosis Does the Level 1 Evidence Translate to Practice? ( Asghar, J; Lonner, BS; Newton, PO; Ren, Y; Samdani, AF; Shah, SA, 2018)

Research

Studies (14)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Complications [VTE (Symptomatic of DVT or PE), Infection (Superficial, Deep), Hematoma, Seroma, Reoperation, and Death]

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	6 (42.86)	29.6817
2010's	7 (50.00)	24.3611
2020's	1 (7.14)	2.80

Authors	Studies
Ahlers, CG	1
Lan, M	1
Schoenecker, JG	1
Borst, AJ	1
Lonner, BS	3
Ren, Y	1
Asghar, J	1
Shah, SA	2
Samdani, AF	2
Newton, PO	2
Hardesty, CK	1
Gordon, ZL	1
Poe-Kochert, C	7
Son-Hing, JP	2
Thompson, GH	7
Lam, H	1
Austin, T	1
Nguyen, T	1
Martus, J	1
Schoenecker, J	1
Iorio, J	1
Bennett, JT	1
Orlando, G	1
Singla, A	1
Dakwar, E	1
Bonet, H	1
Verma, K	2
Errico, T	1
Diefenbach, C	1
Hoelscher, C	1
Peters, A	1
Dryer, J	1
Huncke, T	1
Boenigk, K	1
Florentino-Pineda, I	6
Armstrong, DG	3
Son-Hing, J	1
Errico, TJ	1
Vaz, KM	1
Dhawale, AA	1
Sponseller, PD	1
Bastrom, T	1
Neiss, G	1
Yorgova, P	1
Yaszay, B	1
Abel, MF	1
Shufflebarger, H	1
Gabos, PG	1
Dabney, KW	1
Miller, F	1
Huang, RP	1
Haber, LL	1
Blakemore, LC	2
Adler, P	1
Tripi, P	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
The Effect of Intravenous E-Aminocaproic Acid (EACA) on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy (VRO)[NCT02257580]	Phase 4	28 participants (Actual)	Interventional	2015-04-01	Completed
A Prospective, Randomized, Double-blinded Single-site Control Study Comparing Blood Loss Prevention of Tranexamic Acid (TXA) to Epsilon Aminocaproic Acid (EACA) for Corrective Spinal Surgery[NCT00958581]	Phase 4	177 participants (Actual)	Interventional	2008-12-31	Completed
Aminocaproic Acid and Bleeding in Spinal Surgery[NCT00320619]		182 participants (Actual)	Interventional	2000-09-30	Completed
Topical Application of Tranexamic Acid to Reduce Postoperative Blood Loss in Posterior Approach Spinal Surgery[NCT02063035]	Phase 4	29 participants (Actual)	Interventional	2012-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

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) (NCT02257580)
Timeframe: an expected average of 1 week (post-surgery), Follow-up at 6 weeks

Intraoperative Calculated Total Blood Loss

Intervention	cases per 100,000 person years (Number)
E-Aminocaproic Acid (EACA)	0
Placebo	0

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. (NCT02257580)
Timeframe: Intraoperative (3-6 hours)

Intraoperative Cell Saver Utilization

Intervention	mL (Mean)
E-Aminocaproic Acid (EACA)	535.7
Placebo	628.0

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. (NCT02257580)
Timeframe: Intraoperative, 1 day

Length of Hospital Stay

Intervention	Participants (Count of Participants)
E-Aminocaproic Acid (EACA)	7
Placebo	7

postoperative day of discharge after surgery- day of intake. (NCT02257580)
Timeframe: Post-Surgery, an expected average of 1 week

Post Operative Blood Loss

Postoperative Allogeneic Blood Transfusion

Intervention	days (Mean)
E-Aminocaproic Acid (EACA)	5.5
Placebo	5.1

Intervention	mL (Mean)
E-Aminocaproic Acid (EACA)	72.5
Placebo	103.3

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. (NCT02257580)
Timeframe: Post-Surgery, an expected average of 1 week

Total Blood Loss Over Course of Stay (Intraoperative and Postoperatively Until Discharge)

Blood Loss Volume Following Surgery

Intervention	Participants (Count of Participants)
E-Aminocaproic Acid (EACA)	4
Placebo	3

Intervention	ml (Mean)
Epsilon Aminocaproic Acid	1775
Normal Saline	2116
Tranexamic Acid	1531

Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay. (NCT02063035)
Timeframe: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days

Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge

Intervention	mL (Median)
Tranexamic Acid	534
Placebo	530

Blood loss was calculated from the difference between the level of hemoglobin at the preoperative appointment and the lowest level during the postoperative hospitalization period. Reported here is the change in hemoglobin level after surgery. A negative number indicates a reduction in hemoglobin level. (NCT02063035)
Timeframe: From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery

Hospital Length of Stay in Days

Intervention	grams per deciliter (g/dL) (Median)
Tranexamic Acid	-3.2
Placebo	-4.6

The number of days the participants stayed in the hospital after surgery was recorded. (NCT02063035)
Timeframe: From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks

Post-operative Blood Transfusions During Hospitalization

Intervention	days (Median)
Tranexamic Acid	5
Placebo	6

All units of blood transfused during the hospital stay after surgery were recorded. One red blood cell unit contains 300 to 360 mL of whole blood. (NCT02063035)
Timeframe: From end of surgery on Day 1 to end of hospital stay up to approximately 5 days

Article	Year
Does Amicar affect blood loss in patients with adolescent idiopathic scoliosis treated with pedicle screws and Ponte osteotomies? Surgical technology international, 2013, Volume: 23 Topics: Adult; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Bone Screws; Female; Humans	2013
The relative efficacy of antifibrinolytics in adolescent idiopathic scoliosis: a prospective randomized trial. The Journal of bone and joint surgery. American volume, 2014, May-21, Volume: 96, Issue:10 Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Blood Transfusion; Dou	2014
A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery. BMC surgery, 2010, Apr-06, Volume: 10 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss,	2010
The effect of amicar on perioperative blood loss in idiopathic scoliosis: the results of a prospective, randomized double-blind study. Spine, 2004, Feb-01, Volume: 29, Issue:3 Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Blood Transfusion; Dou	2004
The role of amicar in decreasing perioperative blood loss in idiopathic scoliosis. Spine, 2005, Sep-01, Volume: 30, Issue:17 Suppl Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Child; Double-Blind Me	2005
The role of amicar in decreasing perioperative blood loss in idiopathic scoliosis. Spine, 2005, Sep-01, Volume: 30, Issue:17 Suppl Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Child; Double-Blind Me	2005
The role of amicar in decreasing perioperative blood loss in idiopathic scoliosis. Spine, 2005, Sep-01, Volume: 30, Issue:17 Suppl Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Child; Double-Blind Me	2005
The role of amicar in decreasing perioperative blood loss in idiopathic scoliosis. Spine, 2005, Sep-01, Volume: 30, Issue:17 Suppl Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Child; Double-Blind Me	2005

Article	Year
Antifibrinolytic Therapy in Surgery for Adolescent Idiopathic Scoliosis Does the Level 1 Evidence Translate to Practice? Bulletin of the Hospital for Joint Disease (2013), 2018, Volume: 76, Issue:3 Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Child; Cohort Studies;	2018
Bipolar Sealer Devices Used in Posterior Spinal Fusion for Neuromuscular Scoliosis Reduce Blood Loss and Transfusion Requirements. Journal of pediatric orthopedics, 2018, Volume: 38, Issue:2 Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Blood Transfusion; Cas	2018
Unexpected higher blood loss associated with higher dose ε-aminocaproic acid in pediatric scoliosis surgery. Journal of pediatric orthopedics. Part B, 2019, Volume: 28, Issue:1 Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Dose-Response Relation	2019
The role of Amicar in same-day anterior and posterior spinal fusion for idiopathic scoliosis. Spine, 2008, Sep-15, Volume: 33, Issue:20 Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Blood Transfusion; Chi	2008
Role of Amicar in surgery for neuromuscular scoliosis. Spine, 2008, Nov-15, Volume: 33, Issue:24 Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Blood Transfusion; Cas	2008
Are antifibrinolytics helpful in decreasing blood loss and transfusions during spinal fusion surgery in children with cerebral palsy scoliosis? Spine, 2012, Apr-20, Volume: 37, Issue:9 Topics: Adolescent; Aminocaproic Acid; Analysis of Variance; Antifibrinolytic Agents; Blood Loss, Surgical;	2012
Fibrinogen levels following Amicar in surgery for idiopathic scoliosis. Spine, 2007, Feb-01, Volume: 32, Issue:3 Topics: Adolescent; Aminocaproic Acid; Child; Female; Fibrinogen; Humans; Male; Perioperative Care; Postoper	2007
The Effect of epsilon-aminocaproic acid on perioperative blood loss in patients with idiopathic scoliosis undergoing posterior spinal fusion: a preliminary prospective study. Spine, 2001, May-15, Volume: 26, Issue:10 Topics: Adolescent; Aminocaproic Acid; Antifibrinolytic Agents; Blood Loss, Surgical; Blood Transfusion, Aut	2001

aminocaproic acid and Scoliosis