Drug UseNCT04996368
A Randomized Comparison of Two Doses of Tranexamic Acid in Open-Heart Surgery
A study testing Tranexamic acid injection in people with Drug Use, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
Trial summary
Perioperative bleeding during cardiac surgery is associated with a higher incidence of reoperation and blood transfusion leading to an increase in morbidity and mortality. Coagulopathy is a major cause of excessive bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Use
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNepal
- Study dates
- 1 Feb 2022to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18years scheduled for cardiac surgery and requiring CPB
- Surgery with total cross clamp time more than 60 min (Aortic valve surgery, double valve, CABG)
Who cannot join
- Allergy to tranexamic acid or any of the lysine analogues
- History of seizure
- Chronic homeostasis abnormality, platelet <100000/cumm PT>20sec INR>2
- On anticoagulant
- Severe chronic kidney disease with creatinine clearance less than 30ml/hr
- Deranged liver function test
- Total cross clamp time less than 60 min
Trial locations and contacts
1 site in 1 country.
About this study
Perioperative bleeding during cardiac surgery is associated with a higher incidence of reoperation and blood transfusion leading to an increase in morbidity and mortality. Coagulopathy is a major cause of excessive bleeding. It is associated with use of cardiopulmonary bypass which activates the intrinsic and extrinsic coagulation pathway, platelet dysfunction and systemic inflammatory response. Increase in duration of cardiopulmonary bypass correlates directly with increase bleeding during cardiac surgery. Antifibrinolytic agents like tranexamic acid has shown promising result in major surgeries and in trauma patients. Current clinical practice guidelines recommended use of tranexamic acid in cardiac surgery. There are wide variations in dose of tranexamic acid ranging from 10mg/Kg to 100mg/kg. The higher dose of this drug is associated with seizures and thromboembolic events including stroke. The objective is to find out the minimal effective dose of tranexamic acid in open-heart surgery.
This is a prospective comparative study among the patients undergoing open heart surgery in Shahid Gangalal National Heart Center, Kathmandu Nepal. The inclusion criteria include patients with age more than 18years, surgery with total cross clamp time more than 60 min. The exclusion criteria are the patients with allergy to tranexamic acid or any of the lysine analogues, history of seizure, chronic homeostasis abnormality, on anticoagulants, severe chronic kidney disease with creatinine clearance less than 30ml/hr, deranged liver function test, total cross clamp time less than 60 min. The sample size was calculated to be 100 including 10% dropout cases. Patients will be randomized into two groups Group H (High dose group) and Group L (Low dose group) with a sealed envelope technique. Low-dose TEA consists of 10 mg/kg bolus administration before incision, followed by1 mg/kg/hr infusion; High-dose TEA consists of a 30 mg/kg bolus followed by a 1mg/kg/hr infusion till the end of surgery. Blood sampling and transfusion will be done as per protocol of Shahid Gangalal National Heart Center. The primary study endpoint was the amount of blood loss during the first 24 hours after surgery. The secondary endpoint was the incidence of overall blood transfusion and hemoglobin concentration on the first postoperative day after surgery. All adverse effects of the drug were noted and were treated as per hospital protocol. Data will be collected using the data collection form (proforma). Collected data will be analyzed by means of spss version 20 for windows. The result will be presented as mean ± SD. The continuous variable will be compared between the two groups by student t test and categorical variables with the chi-square test. A minimum level of significance is maintained at the p-value of <0.05.
Read the detailed description
Perioperative bleeding is a common complication during cardiac surgery. This is associated with higher incidence of reoperation and blood transfusion increasing morbidity and mortality. [1,2] Coagulopathy is a major cause of excessive bleeding. It is associated with use of cardiopulmonary bypass which activates the intrinsic and extrinsic coagulation pathway, platelet dysfunction and systemic inflammatory response. [3,4] Increase in duration of cardiopulmonary bypass correlates directly with increase bleeding during cardiac surgery. Antifibrinolytic agents like tranexamic acid has shown promising result in major surgeries and in trauma patients. Tranexamic acid blocks reversibly the lysine binding sites of plasminogen. It prevents the activation of plasmin and thus stops lysis of polymerized fibrin.[5] Current clinical practice guidelines recommended use of tranexamic acid in cardiac surgery.[6] The significance for use of this drug is more for the cardiac surgery with higher risk of bleeding like Aortic valve surgery, Coronary artery bypass grafting, redo surgeries and surgery with prolong cardiopulmonary bypass time.[7] However, there is wide variation in dose of tranexamic acid ranging from 10mg/Kg to 100mg/kg.[8] The tranexamic acid use is not free from adverse events. The higher dose of this drug is associated with seizures and thromboembolic events including stroke. [9,10] The objective of this study is to find out the minimal effective dose of tranexamic acid in high-risk open-heart surgeries.
- Conditions
- Drug Use
- Being tested
- Tranexamic acid injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Randomized comparison of two doses of tranexamic acid as prophylactic before start of incision in open heart surgery use for prevention of bleeding.
| Study group | Role | What they receive |
|---|---|---|
| low dose (10mg/kg) | Active comparator | The dose of tranexamic acid varies widely ranging from 10mg/kg to 100mg/kg. We are comparing 10mg/kg to conventional 30mg/kg dose. The result of this study will help us to review our current practice. Receives: Drug: Tranexamic acid injection |
| high dose or conventional group (30mg/kg) | Active comparator | dose 30mg/kg regularly use in our center as a prophylaxis for prevention of bleeding before open heart surgery Receives: Drug: Tranexamic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of blood loss
to compare the amount of blood loss in two group in first 24 hour post operative
Measured: first 24 hour post operative period
Secondary outcomes (3)
blood tranfusion in first 24 hours
To compare total blood products transfused during 24 hours post-operative period
Measured: first 24 hour post operative period
Reoperations for surgical hemostasis
To compare the incidence of reoperations
Measured: first 24 hour post operative period
Adverse drug reactions
To Compare the adverse drug reactions between the groups
Measured: first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Feb 2022
- Primary completion30 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Drug UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The doses of tranexamic acid used during cardiac surgery varies with the institutions that ranges from 10mg/kg to 100mg/kg. This study aims to compare two doses of tranexamic acid, one dose is a conventional dose ( 30mg/kg) and the other is low dose 10mg/kg. Effects of tranexamic acid regarding its effectiveness and side effects profile will be observed. Participants will be randomly selected into two groups ( low dose group and high dose group)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Gangalal National Heart Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996368
- Sponsor's protocol ID
- SGNHC 4
- Status last verified
- Apr 2023
- First submitted
- 29 Jul 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared to anybody. It will be kept confidential. Overall result of the study will be published.
Publications
Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
PubMed 22611164Robich MP, Koch CG, Johnston DR, Schiltz N, Chandran Pillai A, Hussain ST, Soltesz EG. Trends in blood utilization in United States cardiac surgical patients. Transfusion. 2015 Apr;55(4):805-14. doi: 10.1111/trf.12903. Epub 2014 Nov 2.
PubMed 25363570Biancari F, Mikkola R, Heikkinen J, Lahtinen J, Airaksinen KE, Juvonen T. Estimating the risk of complications related to re-exploration for bleeding after adult cardiac surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2012 Jan;41(1):50-5. doi: 10.1016/j.ejcts.2011.04.023.
PubMed 21640602Ranucci M, Bozzetti G, Ditta A, Cotza M, Carboni G, Ballotta A. Surgical reexploration after cardiac operations: why a worse outcome? Ann Thorac Surg. 2008 Nov;86(5):1557-62. doi: 10.1016/j.athoracsur.2008.07.114.
PubMed 19049749
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Two Doses of Tranexamic Acid in Open-Heart Surgery
- ClinicalTrials.gov ID
- NCT04996368
- Acronym / sponsor ID
- SGNHC 4
- Conditions
- Drug Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shahid Gangalal National Heart CentreUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perioperative bleeding during cardiac surgery is associated with a higher incidence of reoperation and blood transfusion leading to an increase in morbidity and mortality. Coagulopathy is a major cause of excessive bleeding. It is associated with use of cardiopulmonary bypass which activates the intrinsic and extrinsic coagulation pathway, platelet dysfunction and systemic inflammatory response. Increase in duration of cardiopulmonary bypass correlates directly with increase bleeding during cardiac surgery. Antifibrinolytic agents like tranexamic acid has shown promising result in major surgeries and in trauma patients. Current clinical practice guidelines recommended use of tranexamic acid in cardiac surgery. There are wide variations in dose of tranexamic acid ranging from 10mg/Kg to 100mg/kg. The higher dose of this drug is associated with seizures and thromboembolic events including stroke. The objective is to find out the minimal effective dose of tranexamic acid in open-heart surgery.
This is a prospective comparative study among the patients undergoing open heart surgery in Shahid Gangalal National Heart Center, Kathmandu Nepal. The inclusion criteria include patients with age more than 18years, surgery with total cross clamp time more than 60 min. The exclusion criteria are the patients with allergy to tranexamic acid or any of the lysine analogues, history of seizure, chronic homeostasis abnormality, on anticoagulants, severe chronic kidney disease with creatinine clearance less than 30ml/hr, deranged liver function test, total cross clamp time less than 60 min. The sample size was calculated to be 100 including 10% dropout cases. Patients will be randomized into two groups Group H (High dose group) and Group L (Low dose group) with a sealed envelope technique. Low-dose TEA consists of 10 mg/kg bolus administration before incision, followed by1 mg/kg/hr infusion; High-dose TEA consists of a 30 mg/kg bolus followed by a 1mg/kg/hr infusion till the end of surgery. Blood sampling and transfusion will be done as per protocol of Shahid Gangalal National Heart Center. The primary study endpoint was the amount of blood loss during the first 24 hours after surgery. The secondary endpoint was the incidence of overall blood transfusion and hemoglobin concentration on the first postoperative day after surgery. All adverse effects of the drug were noted and were treated as per hospital protocol. Data will be collected using the data collection form (proforma). Collected data will be analyzed by means of spss version 20 for windows. The result will be presented as mean ± SD. The continuous variable will be compared between the two groups by student t test and categorical variables with the chi-square test. A minimum level of significance is maintained at the p-value of <0.05.
Detailed description
Perioperative bleeding is a common complication during cardiac surgery. This is associated with higher incidence of reoperation and blood transfusion increasing morbidity and mortality. [1,2] Coagulopathy is a major cause of excessive bleeding. It is associated with use of cardiopulmonary bypass which activates the intrinsic and extrinsic coagulation pathway, platelet dysfunction and systemic inflammatory response. [3,4] Increase in duration of cardiopulmonary bypass correlates directly with increase bleeding during cardiac surgery. Antifibrinolytic agents like tranexamic acid has shown promising result in major surgeries and in trauma patients. Tranexamic acid blocks reversibly the lysine binding sites of plasminogen. It prevents the activation of plasmin and thus stops lysis of polymerized fibrin.[5] Current clinical practice guidelines recommended use of tranexamic acid in cardiac surgery.[6] The significance for use of this drug is more for the cardiac surgery with higher risk of bleeding like Aortic valve surgery, Coronary artery bypass grafting, redo surgeries and surgery with prolong cardiopulmonary bypass time.[7] However, there is wide variation in dose of tranexamic acid ranging from 10mg/Kg to 100mg/kg.[8] The tranexamic acid use is not free from adverse events. The higher dose of this drug is associated with seizures and thromboembolic events including stroke. [9,10] The objective of this study is to find out the minimal effective dose of tranexamic acid in high-risk open-heart surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The doses of tranexamic acid used during cardiac surgery varies with the institutions that ranges from 10mg/kg to 100mg/kg. This study aims to compare two doses of tranexamic acid, one dose is a conventional dose ( 30mg/kg) and the other is low dose 10mg/kg. Effects of tranexamic acid regarding its effectiveness and side effects profile will be observed. Participants will be randomly selected into two groups ( low dose group and high dose group)
| Arm | Type | Receives |
|---|---|---|
| low dose (10mg/kg) | Active comparator | Drug: Tranexamic acid injectionThe dose of tranexamic acid varies widely ranging from 10mg/kg to 100mg/kg. We are comparing 10mg/kg to conventional 30mg/kg dose. The result of this study will help us to review our current practice. |
| high dose or conventional group (30mg/kg) | Active comparator | Drug: Tranexamic acid injectiondose 30mg/kg regularly use in our center as a prophylaxis for prevention of bleeding before open heart surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18years scheduled for cardiac surgery and requiring CPB
- Surgery with total cross clamp time more than 60 min (Aortic valve surgery, double valve, CABG)
Key exclusion criteria (7 listed)
- Allergy to tranexamic acid or any of the lysine analogues
- History of seizure
- Chronic homeostasis abnormality, platelet <100000/cumm PT>20sec INR>2
- On anticoagulant
- Severe chronic kidney disease with creatinine clearance less than 30ml/hr
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acid injectionRandomized comparison of two doses of tranexamic acid as prophylactic before start of incision in open heart surgery use for prevention of bleeding. | Drug | high dose or conventional group (30mg/kg), low dose (10mg/kg) |
Primary outcome
amount of blood loss
Time frame: first 24 hour post operative period
to compare the amount of blood loss in two group in first 24 hour post operative
3 secondary outcomes
blood tranfusion in first 24 hours
Time frame: first 24 hour post operative period
Reoperations for surgical hemostasis
Time frame: first 24 hour post operative period
Adverse drug reactions
Time frame: first 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 22611164Ker K, Edwards P, Perel P, Shakur H, Roberts I. Effect of tranexamic acid on surgical bleeding: systematic review and cumulative meta-analysis. BMJ. 2012 May 17;344:e3054. doi: 10.1136/bmj.e3054.
- Background: PubMed 25363570Robich MP, Koch CG, Johnston DR, Schiltz N, Chandran Pillai A, Hussain ST, Soltesz EG. Trends in blood utilization in United States cardiac surgical patients. Transfusion. 2015 Apr;55(4):805-14. doi: 10.1111/trf.12903. Epub 2014 Nov 2.
- Background: PubMed 21640602Biancari F, Mikkola R, Heikkinen J, Lahtinen J, Airaksinen KE, Juvonen T. Estimating the risk of complications related to re-exploration for bleeding after adult cardiac surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2012 Jan;41(1):50-5. doi: 10.1016/j.ejcts.2011.04.023.
- Background: PubMed 19049749Ranucci M, Bozzetti G, Ditta A, Cotza M, Carboni G, Ballotta A. Surgical reexploration after cardiac operations: why a worse outcome? Ann Thorac Surg. 2008 Nov;86(5):1557-62. doi: 10.1016/j.athoracsur.2008.07.114.
- Individual participant dataSharing planned: No. IPD will not be shared to anybody. It will be kept confidential. Overall result of the study will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic acid injection in people with Drug Use, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of blood loss (time frame: first 24 hour post operative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04996368, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.