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Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery (DEPOSITION)

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ClinicalTrials.gov Identifier: NCT03376061
Recruitment Status : Completed
First Posted : December 18, 2017
Results First Posted : September 9, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Bleeding
Surgical Blood Loss
Intervention Drug: Tranexamic Acid
Enrollment 97
Recruitment Details Between December 2017 and April 2018 a total of 97 patients were randomized to the topical (n = 49) and intravenous (n = 48) groups.
Pre-assignment Details  
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care. Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Period Title: Overall Study
Started 49 48
Completed 49 48
Not Completed 0 0
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control) Total
Hide Arm/Group Description 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients will receive intravenous placebo (saline) administered as per anesthetist standard of care. Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. Total of all reporting groups
Overall Number of Baseline Participants 49 48 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 48 participants 97 participants
67.3  (9.4) 67.8  (9.2) 67.5  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
Female
5
  10.2%
6
  12.5%
11
  11.3%
Male
44
  89.8%
42
  87.5%
86
  88.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
White/Caucasian
46
  93.9%
46
  95.8%
92
  94.8%
Hispanic/Latino
0
   0.0%
2
   4.2%
2
   2.1%
Southeast Asian/Malaysian
1
   2.0%
0
   0.0%
1
   1.0%
Aboriginal/Native Persons
2
   4.1%
0
   0.0%
2
   2.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 49 participants 48 participants 97 participants
49 48 97
Diabetes mellitus  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
17
  34.7%
21
  43.8%
38
  39.2%
Stroke  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
3
   6.1%
3
   6.3%
6
   6.2%
Transient ischemic attack  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
2
   4.1%
2
   4.2%
4
   4.1%
Carotid endarterectomy/stent  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
3
   6.1%
1
   2.1%
4
   4.1%
History of seizures  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
1
   2.0%
0
   0.0%
1
   1.0%
New oral anticoagulants (NOAC)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
3
   6.1%
4
   8.3%
7
   7.2%
Aspirin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
38
  77.6%
42
  87.5%
80
  82.5%
Clopidogrel (Plavix)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
12
  24.5%
7
  14.6%
19
  19.6%
Ticagrelor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 48 participants 97 participants
3
   6.1%
5
  10.4%
8
   8.2%
1.Primary Outcome
Title Median Volume of Mediastinal Fluid Collected From Participants
Hide Description Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure
Time Frame Fluid collected in the first 24 hours after the surgical procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description:
50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Overall Number of Participants Analyzed 49 48
Median (Inter-Quartile Range)
Unit of Measure: mL
500
(350 to 750)
540
(420 to 700)
2.Secondary Outcome
Title Number of Participants With Seizures
Hide Description Patients experiencing a post-operative seizure
Time Frame Patients will be followed post-operatively until hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description:
50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Overall Number of Participants Analyzed 49 48
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.1%
3.Secondary Outcome
Title Number of Participants With Mortality
Hide Description The occurrence of death due to any cause
Time Frame Patients will be followed post-operatively until hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description:
50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Overall Number of Participants Analyzed 49 48
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
1
   2.1%
4.Secondary Outcome
Title Number of Participants With RBC Transfusion
Hide Description Patients requiring a red blood cell transfusion
Time Frame Intra-operative and post-operative RBC transfusions
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description:
50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Overall Number of Participants Analyzed 49 48
Measure Type: Count of Participants
Unit of Measure: Participants
19
  38.8%
23
  47.9%
5.Secondary Outcome
Title Number of Participants With Re-operation for Bleeding or Tamponade
Hide Description Occurrence of re-operation for the purpose of bleeding or cardiac tamponade
Time Frame Patients will be followed post-operatively until hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description:
50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Overall Number of Participants Analyzed 49 48
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.1%
6.Secondary Outcome
Title Median Number of Hours Participants Spent in ICU
Hide Description Number of hours participants spent in the intensive care unit (ICU)
Time Frame Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description:
50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.
Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Overall Number of Participants Analyzed 49 48
Median (Inter-Quartile Range)
Unit of Measure: hours
23
(19 to 45)
26
(22 to 53)
7.Secondary Outcome
Title Mean Concentration of TxA in Plasma Collected From Participants
Hide Description Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU
Time Frame on arrival in ICU within 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
4 patients from the topical TxA group and 3 patients from the intravenous TxA group were excluded because they either did not receive a TxA dose or received an incomplete TxA dose.
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description:
50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients will receive intravenous placebo (saline) administered as per anesthetist standard of care.
Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
Overall Number of Participants Analyzed 45 45
Mean (Standard Deviation)
Unit of Measure: microgram per milliliter per kilogram
0.12  (0.08) 0.25  (0.13)
Time Frame 30 days post-operatively
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Topical TxA (Intervention) Intravenous TxA (Control)
Hide Arm/Group Description 50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care. Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.
All-Cause Mortality
Topical TxA (Intervention) Intravenous TxA (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/49 (2.04%)   1/48 (2.08%) 
Show Serious Adverse Events Hide Serious Adverse Events
Topical TxA (Intervention) Intravenous TxA (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/48 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Topical TxA (Intervention) Intravenous TxA (Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/48 (0.00%) 
Due to the small sample size (N<100 patients) the DEPOSITION pilot trial is not sufficiently powered to detect statistically significant differences between topical and intravenous TxA groups.
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: Research assistant
Organization: Population Health Research Institute
Phone: 19055212100 ext 40582
EMail: Austin.Browne@phri.ca
Publications:
Layout table for additonal information
Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT03376061     History of Changes
Other Study ID Numbers: DEPOSITION 1.0 2017-07-28
First Submitted: November 17, 2017
First Posted: December 18, 2017
Results First Submitted: May 28, 2019
Results First Posted: September 9, 2019
Last Update Posted: September 24, 2019