Efficacy of Tranexamic acid spray on reduction of time taken for a complete cessation of Bleeding in acute Trauma patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Shilpa Medicare Ltd.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- To evaluate the safety and efficacy of the Tranexamic acid (TXA) spray 10% w/v with placebo (Placebo spray) on acute injury patients admitted to the ED.
Study Overview
Brief Summary
Adequatehaemostasis after trauma and during surgical operation is a big challenge inmodern medicine. About the 40% traumatic and more than 90% of combat deathstook place in pre-hospital settings. And about the 50% from these deaths havebeen reported due to massive blood loss (1,2). The US FDA first approvedintravenous Tranexamic acid (TXA) in 1986 for short-term use as hemostaticagent. In 2009, FDA approved the Tranexamic acid (TXA) oral form (Tablets) forthe treatment of menorrhagia. Tranexamic acid -4-(aminomethyl)cyclohexane-1-carboxylic acid- is a synthetic amino acid lysine derivative thatcompetitively blocks the lysine binding sites on plasminogen (3,4).
IntravenousTranexamic acid is commonly used in severely bleeding patients and numberclinical trials were conducted. In 2010, CRASH-2 trial was a multi-centerrandomized, double-blinded, controlled trial where patients either receivedTranexamic acid or placebo in adult trauma patients with significanthemorrhage, tranexamic acid reduced all-cause mortality at 4 weeks and thedeath rate due to bleeding in trauma patients (5,6). The MATTERs trial followedthis in 2011 revealed TXA decreased overall mortality, notably those requiringmassive transfusion protocols (7). The off-label intravenous uses of Tranexamicacid are seen in surgical operations to reduce blood loss. Surgical operationslike total knee arthroplasty (8), orthognathic surgery (9), cardiac surgery(10) spinal surgeries, and transurethral retrograde prostatectomy (TURP,11).
Based onresults of clinical studies, oral Tranexamic acid was also used to reduce bloodloss in post-procedural after cervical conization (12) hereditary angioedema (13),transurethral retrograde prostatectomy (TURP) and tooth extractions in patientson oral anticoagulants (14). The research studies observed that Tranexamic acidis effective in reducing blood loss and transfusion without significant risksfor increased mortality, stroke, myocardial infarction, or renal failure (15,16,17).
In thiscontext, In the emergency and trauma setting, as bleeding control is animportant part, we are planning to investigate the use of tranexamic acidspray.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adult more than 18 years acute trauma patients with isolated extremity wounds with active bleeding Time since injury.
- •less than 6 hours.
Exclusion Criteria
- •Paediatric trauma patient age less than 18 yrs Patients with known Blood Coagulopathy Patients on anti-platelet and anti-fibrinolytics Patients suffering with Co-morbidities and pregnant women Patients with a history of hypersensitivity to tranexamic acid and any of the ingredients.
Outcomes
Primary Outcomes
To evaluate the safety and efficacy of the Tranexamic acid (TXA) spray 10% w/v with placebo (Placebo spray) on acute injury patients admitted to the ED.
Time Frame: Comparison and measurement of time to hemostasis at 1 min, 2 min 3 min, 5 min, 10 min, 15 min, 20min and 30 min.
Secondary Outcomes
- Comparison and measurement of time to hemostasis at 1 min, 2 min 3 min, 5 min, 10 min, 15 min, 20min and 30 min application of both test and placebo after tooth extraction to the respective groups.(Comparison and measurement of time to hemostasis at 1 min, 2 min 3 min, 5 min, 10 min, 15 min, 20min and 30 min.)