Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 65 of 419 for:    TRANEXAMIC ACID

Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02063035
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Kirkham Wood, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions Lumbar Spinal Stenosis
Thoracic Spinal Stenosis
Interventions Drug: Tranexamic Acid
Drug: Placebo
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description Participants undergoing spinal surgery received a single, topical dose of 3 grams (g) tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated. Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Period Title: Overall Study
Started 12 17
Completed 12 17
Not Completed 0 0
Arm/Group Title Tranexamic Acid Placebo Total
Hide Arm/Group Description Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated. Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated. Total of all reporting groups
Overall Number of Baseline Participants 12 17 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 12 participants 17 participants 29 participants
69
(62 to 72)
66
(50 to 73)
68
(60 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 17 participants 29 participants
Female
8
  66.7%
12
  70.6%
20
  69.0%
Male
4
  33.3%
5
  29.4%
9
  31.0%
1.Primary Outcome
Title Change in Hemoglobin Level From Preoperative Appointment to Postoperative Hospital Discharge
Hide Description 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.
Time Frame From preoperative appointment approximately one week before surgery to end of hospital stay up to approximately 5 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants, for whom both preoperative and postoperative time points were collected, are reported in this outcome measure.
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Overall Number of Participants Analyzed 11 15
Median (Inter-Quartile Range)
Unit of Measure: grams per deciliter (g/dL)
-3.2
(-4.6 to -2.4)
-4.6
(-5.3 to -4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tranexamic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1318
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Blood Loss Volume Following Surgery
Hide Description Blood loss following surgery was defined as the total amount of fluid collected from the drain in the wound site during the hospital stay.
Time Frame From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Overall Number of Participants Analyzed 12 17
Median (Inter-Quartile Range)
Unit of Measure: mL
534
(260 to 705)
530
(320 to 795)
3.Secondary Outcome
Title Hospital Length of Stay in Days
Hide Description The number of days the participants stayed in the hospital after surgery was recorded.
Time Frame From end of surgery on Day 1 to end of hospital stay up to approximately 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Overall Number of Participants Analyzed 12 17
Median (Inter-Quartile Range)
Unit of Measure: days
5
(4 to 8)
6
(5 to 7)
4.Secondary Outcome
Title Post-operative Blood Transfusions During Hospitalization
Hide Description 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.
Time Frame From end of surgery on Day 1 to end of hospital stay up to approximately 5 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description:
Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
Overall Number of Participants Analyzed 12 17
Median (Inter-Quartile Range)
Unit of Measure: units of blood
0
(0 to 1)
0
(0 to 1)
Time Frame From time of admission to hospital for surgery up to study completion (up to approximately 2.5 years).
Adverse Event Reporting Description Participants were monitored only for the following serious adverse events from time of admission to hospital for surgery up to study completion: myocardial infarction, stroke, thrombosis, and postoperative infection. Non-serious adverse events were not collected in this study.
 
Arm/Group Title Tranexamic Acid Placebo
Hide Arm/Group Description Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated. Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
All-Cause Mortality
Tranexamic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tranexamic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/12 (25.00%)      1/17 (5.88%)    
Cardiac disorders     
Myocardial infaction   1/12 (8.33%)  1 0/17 (0.00%)  0
Surgical and medical procedures     
Postoperative wound infection   1/12 (8.33%)  1 1/17 (5.88%)  1
Postoperative wound infection after release from hospital   1/12 (8.33%)  1 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tranexamic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kirkham B. Wood
Organization: Massachusetts General Hospital, Boston, MA, USA
Phone: 617-726-2000 ext +1
EMail: kbwood@stanford.edu
Publications:
Layout table for additonal information
Responsible Party: Kirkham Wood, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02063035     History of Changes
Other Study ID Numbers: 2012P000266
2012P000266 ( Other Identifier: Massachusetts General Hospital IRB approved )
First Submitted: December 19, 2013
First Posted: February 14, 2014
Results First Submitted: March 23, 2017
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017