Tranexamic AcidPhase 4NCT04986813
Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery Tranexamic Acid in Trauma Surgery
A Phase 4 study testing Tranexamic acid injection and Normal Saline in people with Tranexamic Acid and Trauma, run by Jaspreet Singh at 1 site in India.
Trial summary
This study was done to evaluate the efficacy of Tranexamic Acid (TXA) in reducing blood transfusion requirement in patients of lower limb trauma undergoing surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tranexamic Acid, Trauma, Lower Extremity Fracture
- What is being tested?
- Tranexamic acid injection and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2017to 31 Aug 2018
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients suffering from lower limb trauma
Who cannot join
- Presence of old implant or infection at the fracture site,
- Any blood coagulation disorder
- Patients undergoing percutaneous wire placement procedures for fracture fixation
- Polytrauma
- Non-consenting patients
- Psychiatric patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Tranexamic Acid in Reducing Requirement of Blood Transfusion in Lower Limb Trauma Surgery: A Prospective Randomized Controlled Study
This study was done to evaluate the efficacy of Tranexamic Acid (TXA) in reducing blood transfusion requirement in patients of lower limb trauma undergoing surgery.
Read the detailed description
This was a single centre, parallel group, prospective randomized control study. 116 patients of lower limb trauma presented between April 2017 to August 2018 at Civil Hospital Rajpura. 16 patients were excluded due to old fracture, percutaneous wire fixation or non-consenting patient. The remaining 100 patients were randomized into two groups. 50 patients were given 1 gram of TXA before surgery and 50 patients were not given TXA. Fall in Hb, requirement of blood transfusion, number of days admitted in the hospital after surgery and evidence of deep vein thrombosis were monitored.
- Conditions
- Tranexamic Acid, Trauma, Lower Extremity Fracture
- Being tested
- Tranexamic acid injection, Normal Saline
- Keywords
- Tranexamic acid, Deep Vein Thrombosis, Blood transfusion
- Medical subject headings
- Wounds and Injuries, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Also called Inj Tranexa
1 g of TXA in 100 ml of normal saline
Normal SalineOther
Also called NS
100 ml
| Study group | Role | What they receive |
|---|---|---|
| Group Tranexamic Acid | Active comparator | 50 patients were given 1 gram of Tranexamic acid (TXA) intravenously pre-operatively. Intravenous TXA was administered, at the time of start of surgical incision. Receives: Drug: Tranexamic acid injection |
| Control group | Placebo comparator | 50 patients were kept as a control group and were not given TXA. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement of number of units of blood transfusion
From the date of surgery till time of discharge
Measured: Average of 15 days
Secondary outcomes (3)
Evidence of deep vein thrombosis by Wells Score
Based on Wells et al Clinical model for DVT
Measured: Average of 15 days (From the date of surgery till time of discharge)
Change in Haemoglobin level post surgery
From the date of surgery till time of discharge
Measured: Average of 15 days (From the date of surgery till time of discharge)
Number of days admitted in the hospital after surgery
From the date of admission till time of discharge
Measured: Average of 15 days (From the date of admission till time of discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Apr 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tranexamic AcidStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a single centre, parallel group, prospective randomized control study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaspreet Singh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaspreet Singh, AP Jain Civil Hospital, Rajpura
- Investigators
- Gurleen Kaur, MD, Study director, Adesh Medical College & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986813
- Sponsor's protocol ID
- PHMA/GSMCH-17/IEC-29A
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaye JA, Jick H. Epidemiology of lower limb fractures in general practice in the United Kingdom. Inj Prev. 2004 Dec;10(6):368-74. doi: 10.1136/ip.2004.005843.
PubMed 15583259Zhang P, Bai J, He J, Liang Y, Chen P, Wang J. A systematic review of tranexamic acid usage in patients undergoing femoral fracture surgery. Clin Interv Aging. 2018 Sep 4;13:1579-1591. doi: 10.2147/CIA.S163950. eCollection 2018.
PubMed 30233155Fischer PE, Bulger EM, Perina DG, Delbridge TR, Gestring ML, Fallat ME, Shatz DV, Doucet J, Levy M, Stuke L, Zietlow SP, Goodloe JM, VanderKolk WE, Fox AD, Sanddal ND. Guidance Document for the Prehospital Use of Tranexamic Acid in Injured Patients. Prehosp Emerg Care. 2016 Sep-Oct;20(5):557-9. doi: 10.3109/10903127.2016.1142628. Epub 2016 Mar 17.
PubMed 26985786
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tranexamic Acid in Reducing Requirement of Blood Transfusion in Lower Limb Trauma Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04986813
- Acronym / sponsor ID
- PHMA/GSMCH-17/IEC-29A
- Conditions
- Tranexamic Acid, Trauma, Lower Extremity Fracture
- Keywords
- Tranexamic acid, Deep Vein Thrombosis, Blood transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jaspreet SinghUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 3 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.
This study was done to evaluate the efficacy of Tranexamic Acid (TXA) in reducing blood transfusion requirement in patients of lower limb trauma undergoing surgery.
Detailed description
This was a single centre, parallel group, prospective randomized control study. 116 patients of lower limb trauma presented between April 2017 to August 2018 at Civil Hospital Rajpura. 16 patients were excluded due to old fracture, percutaneous wire fixation or non-consenting patient. The remaining 100 patients were randomized into two groups. 50 patients were given 1 gram of TXA before surgery and 50 patients were not given TXA. Fall in Hb, requirement of blood transfusion, number of days admitted in the hospital after surgery and evidence of deep vein thrombosis were monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This was a single centre, parallel group, prospective randomized control study.
| Arm | Type | Receives |
|---|---|---|
| Group Tranexamic Acid | Active comparator | Drug: Tranexamic acid injection50 patients were given 1 gram of Tranexamic acid (TXA) intravenously pre-operatively. Intravenous TXA was administered, at the time of start of surgical incision. |
| Control group | Placebo comparator | Other: Normal Saline50 patients were kept as a control group and were not given TXA. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients suffering from lower limb trauma
Key exclusion criteria (6 listed)
- Presence of old implant or infection at the fracture site,
- Any blood coagulation disorder
- Patients undergoing percutaneous wire placement procedures for fracture fixation
- Polytrauma
- Non-consenting patients
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 injectionAlso: Inj Tranexa1 g of TXA in 100 ml of normal saline | Drug | Group Tranexamic Acid |
| Normal SalineAlso: NS100 ml | Other | Control group |
Primary outcome
Requirement of number of units of blood transfusion
Time frame: Average of 15 days
From the date of surgery till time of discharge
3 secondary outcomes
Evidence of deep vein thrombosis by Wells Score
Time frame: Average of 15 days (From the date of surgery till time of discharge)
Change in Haemoglobin level post surgery
Time frame: Average of 15 days (From the date of surgery till time of discharge)
Number of days admitted in the hospital after surgery
Time frame: Average of 15 days (From the date of admission till time of discharge)
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 3 Aug 2021.
- Background: PubMed 15583259Kaye JA, Jick H. Epidemiology of lower limb fractures in general practice in the United Kingdom. Inj Prev. 2004 Dec;10(6):368-74. doi: 10.1136/ip.2004.005843.
- Results publication: PubMed 30233155Zhang P, Bai J, He J, Liang Y, Chen P, Wang J. A systematic review of tranexamic acid usage in patients undergoing femoral fracture surgery. Clin Interv Aging. 2018 Sep 4;13:1579-1591. doi: 10.2147/CIA.S163950. eCollection 2018.
- Results publication: PubMed 26985786Fischer PE, Bulger EM, Perina DG, Delbridge TR, Gestring ML, Fallat ME, Shatz DV, Doucet J, Levy M, Stuke L, Zietlow SP, Goodloe JM, VanderKolk WE, Fox AD, Sanddal ND. Guidance Document for the Prehospital Use of Tranexamic Acid in Injured Patients. Prehosp Emerg Care. 2016 Sep-Oct;20(5):557-9. doi: 10.3109/10903127.2016.1142628. Epub 2016 Mar 17.
- Individual participant dataSharing planned: No
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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.
Gurleen Kaur, MD study director
Adesh Medical College & Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid injection and Normal Saline in people with Tranexamic Acid and Trauma, run by Jaspreet Singh at 1 site in India.
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 1 inclusion and 6 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 3 Aug 2021. 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 India. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Requirement of number of units of blood transfusion (time frame: Average of 15 days). 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 NCT04986813, which also lists 3 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 3 Aug 2021.