Blood Loss, Blood Loss, Surgical, Burn Excisional Surgery, Burns, Tranexamic Acid
Conditions
Keywords
Blood loss, Tranexamic Acid, Burn excisional surgery, Burns
Brief summary
The purpose of this study is to access the efficacy of the drug tranexamic acid in reducing blood loss during burn excision surgery.
Detailed description
This study is a double-blinded, randomized placebo-controlled trial. After informed consent patients will be randomized in either the placebo or the tranexamic acid group (1500 mg). The intervention will be conducted during burn excisional surgery. First, the participant with be anesthetized, whereafter the study medication is administered.
Interventions
DRUGTranexamic acid
Tranexamic acid 1500 mg
DRUGPlacebo
Placebo, sodium chloride 0.9%
Sponsors
Association of Dutch Burn Centres
Martini Hospital Groningen
Red Cross Hospital Beverwijk
Maasstad Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for burn excisional surgery * An expected blood loss of ≥250ml based on the estimation by the performing surgeon on the basis of: (1) ≥ 2 % body surface area excision planned (100-200 cc / % total body surface area, (2) operation technique used (some techniques show more blood loss than others), (3) time after burn trauma (i.e. expected healing) * ≥18 year * informed consent of patient or legal representative * Patients or legal representative should have enough knowledge of Dutch to provide informed consent
Exclusion criteria
* Patients with a recorded coagulopathy in their history * The use of anticoagulants (except acetylsalicylic acid or (intensive) prophylaxis low molecular weight heparin \>12 hours before surgery) * Severe kidney failure (creatinine \>500 μmol/L) * Allergy for tranexamic acid * Diagnosis of acute venous-/arterial thrombosis within 3 months before inclusion * Diffuse intravascular coagulation (based on the diffuse intranasal coagulation-score \>5) * Pregnancy * Active breastfeeding * History of epilepsy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | During burn excisional surgery | Volume of blood loss measured during surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in days | The length of stay will be evaluated after 3 months after inclusion. If, after 3 months, the patient is still admitted, the status of hospitalisation will be check after an addition 3 months. | Number of days admitted after burn trauma. |
| Graft failure in % of total graft | During burn excisional surgery | % of graft failure of the total graft. |
| Cardiopulmonary complications | Within the first 30 days after burn excisional surgery | i.e. pulmonary embolism, arterial embolism. |
| Neurologic complications | Within the first 30 days after burn excisional surgery | i.e. stroke of epilepsy |
| Hospital Mortality | During total admittance of the patient | % of mortality in patients participating in this study. |
| Extend of fibrinolysis during burn excisional surgery | During burn excisional surgery | Measured by ROTEM analysis |
| Strength of blood clot | During burn excisional surgery | Analysis will be performed using (electron) microscope to investigate: strength, thickness, structure of fibrin, fibrin clot networks and cell disposition within the blood clot. |
| Transfusion requirements | Perioperative, within the first day after surgery. | Number of transfusions in the perioperative phase. |
| The need for escape medication | During burn excisional surgery | Out of protocol administration of tranexamic acid based on massive blood loss. |
Countries
Netherlands
Contacts
Primary ContactC.H. van der Vlies, MD, PhD
Outcome results
None listed