Trial Outcomes & Findings for The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery (NCT NCT01728636)

NCT ID: NCT01728636

Last Updated: 2021-01-26

Results Overview

Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 61 participants
• Primary outcome timeframe: Intraoperative period (approximately 12 hours)
• Results posted on: 2021-01-26

Participant Flow

Participant milestones

Measure	Tranexamic Acid Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure
Overall Study STARTED	31	30
Overall Study COMPLETED	31	30
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

Measure	Tranexamic Acid n=31 Participants Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo n=30 Participants Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Total n=61 Participants Total of all reporting groups
Age, Continuous	68 Years n=31 Participants	65 Years n=30 Participants	66 Years n=61 Participants
Sex: Female, Male Female	21 Participants n=31 Participants	21 Participants n=30 Participants	42 Participants n=61 Participants
Sex: Female, Male Male	10 Participants n=31 Participants	9 Participants n=30 Participants	19 Participants n=61 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	31 participants n=31 Participants	30 participants n=30 Participants	61 participants n=61 Participants
Weight (kilogram)	82.1 kilogram (kg) STANDARD_DEVIATION 18.9 • n=31 Participants	72.9 kilogram (kg) STANDARD_DEVIATION 21.7 • n=30 Participants	77 kilogram (kg) STANDARD_DEVIATION 20 • n=61 Participants
Height (cm)	165.9 centimeters STANDARD_DEVIATION 9.4 • n=31 Participants	161.7 centimeters STANDARD_DEVIATION 11.6 • n=30 Participants	163 centimeters STANDARD_DEVIATION 11 • n=61 Participants
Body Mass Index	31.2 kg/m^2 n=31 Participants	26.4 kg/m^2 n=30 Participants	29 kg/m^2 n=61 Participants
ASA status	2 score on a scale n=31 Participants	2 score on a scale n=30 Participants	2 score on a scale n=61 Participants
Medical History (none)	6 Participants n=31 Participants	12 Participants n=30 Participants	18 Participants n=61 Participants
History of hypertension	13 Participants n=31 Participants	21 Participants n=30 Participants	34 Participants n=61 Participants
History of coronary artery disease	0 Participants n=31 Participants	2 Participants n=30 Participants	2 Participants n=61 Participants
History of atrial fibrillation	1 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=61 Participants
History of peripheral vascular disease	1 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=61 Participants
History of diabetes melitus	3 Participants n=31 Participants	7 Participants n=30 Participants	10 Participants n=61 Participants
History of asthma	3 Participants n=31 Participants	3 Participants n=30 Participants	6 Participants n=61 Participants
History of obstructive sleep apnea	4 Participants n=31 Participants	4 Participants n=30 Participants	8 Participants n=61 Participants
Baseline Hemoglobin (g/dl)	10.6 g/dl (grams per deciliter) STANDARD_DEVIATION 1.0 • n=31 Participants	10.6 g/dl (grams per deciliter) STANDARD_DEVIATION 1.4 • n=30 Participants	10.6 g/dl (grams per deciliter) STANDARD_DEVIATION 1.2 • n=61 Participants
Baseline hematocrit	32.1 Percent STANDARD_DEVIATION 2.9 • n=31 Participants	31.9 Percent STANDARD_DEVIATION 4 • n=30 Participants	32 Percent STANDARD_DEVIATION 3.4 • n=61 Participants
Baseline Platelets	136 x 10^5 cells/mm^3 n=31 Participants	133 x 10^5 cells/mm^3 n=30 Participants	135 x 10^5 cells/mm^3 n=61 Participants
Baseline fibrinogen (mg/dL)	272 miligrams per deciliter n=31 Participants	268.5 miligrams per deciliter n=30 Participants	270 miligrams per deciliter n=61 Participants
Preoperative risk of major transfusion	212 Percent n=31 Participants	505 Percent n=30 Participants	358 Percent n=61 Participants
Total number of vertebral levels	15 Vertebra levels n=31 Participants	10 Vertebra levels n=30 Participants	13 Vertebra levels n=61 Participants

PRIMARY outcome

Timeframe: Intraoperative period (approximately 12 hours)

Total red blood cells transfused in the intraoperative period in (mL). Total RBC equal packed red blood cells and cell saver infusion.

Outcome measures

Measure	Tranexamic Acid n=31 Participants Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo n=30 Participants Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure
Total Red Blood Cells Transfused in the Intraoperative Period	1140 milliliters Interval 560.0 to 1744.0	1460 milliliters Interval 1115.0 to 2650.0

SECONDARY outcome

Timeframe: 24 hours after skin incision

Total additional blood products (fresh frozen plasma, cryoprecipitate, and platelets) transfused in the perioperative period measured in units.

Outcome measures

Measure	Tranexamic Acid n=31 Participants Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo n=30 Participants Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure
Additional Blood Products Transfused	1 Units Interval 1.0 to 4.0	2 Units Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: Time of surgery to date of discharge from hospital (average 7 days)

Number of participants who experienced arterial or venous thromboembolism, neurologic complications (including stroke, seizure,and delirium), infections, and pulmonary renal or cardiac adverse outcomes (demand ischemia, myocardial infarction or new arrhythmia) before another operative procedure or hospital discharge.

Outcome measures

Measure	Tranexamic Acid n=31 Participants Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo n=30 Participants Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure
Post Operative Major Morbidity	9 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Incision to skin closure (approximately 10 hours)

Estimated Intraoperative blood loss in milliliters (mLs)

Outcome measures

Measure	Tranexamic Acid n=31 Participants Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo n=30 Participants Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure
Estimated Intraoperative Blood Loss	1550 Milliliters Interval 1200.0 to 3200.0	1600 Milliliters Interval 1200.0 to 2500.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Intraoperative period

Total milligrams of intravenous tranexamic acid administered during the surgical procedure.

Outcome measures

Measure	Tranexamic Acid n=31 Participants Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo n=30 Participants Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure
Total Tranexamic Acid Dose (mg)	1408 milligrams Interval 1235.0 to 1685.0	0 milligrams Interval 0.0 to 0.0

POST_HOC outcome

Timeframe: Minutes

Total operating room time from incision to closure of incision in minutes.

Outcome measures

Measure	Tranexamic Acid n=31 Participants Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo n=30 Participants Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure
Total Operating Room Time	602 Minutes Interval 522.0 to 653.0	576 Minutes Interval 526.0 to 690.0

Adverse Events

Tranexamic Acid

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tranexamic Acid n=31 participants at risk Tranexamic acid 10mg/kg loading dose given pre-incision and 1mg/kg/hr infusion throughout intraoperative period Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure	Placebo n=30 participants at risk Normal saline placebo loading dose 0.5ml/kg and infusion at 0.5ml/kg/hr throughout operative course Tranexamic Acid: intravenous administration of bolus and infusion for duration of surgical procedure
General disorders Composite outcome of postoperative adverse events	29.0% 9/31 • Number of events 9 • Start of surgery to discharge from the hospital ( approximately 7 days)	30.0% 9/30 • Number of events 9 • Start of surgery to discharge from the hospital ( approximately 7 days)

Other adverse events

Adverse event data not reported

Additional Information

Luanne Carabini MD

Northwestern University

Phone: 312-695-0061

Email: l-carabini@northwestern.edu

Results disclosure agreements

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