This study has been transitioned to CTIS with ID 2024-513573-49-00 check the CTIS register for the current data. The objectives of this study are twofold, (1) to investigate whether tranexamic acid reduces the volume of blood loss and number of…
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are the volume of blood loss and the extend of
fibrinolysis.
Secondary outcome
Blood transfusion requirements:
- Number of blood product transfused
Hospital Mortality
Length of stay
Operation success:
- Success of skin graft (percentage successful take)
Cardiopulmonary complication (i.e. arterial embolism)
Neurologic complications (i.e. stroke, conclusion)
Strength of the blood cloth and fibrin-structures
Background summary
Despite an increase in knowledge, blood loss during burn excisional surgery
remains a major challenge and is an independent predictor of mortality. During
burn excisional surgery limited measures are available to control the bleeding
during surgery. Increased fibrinolysis could be one of the contributing factors
of blood loss during burn excisional surgery. Tranexamic acid is able to
inhibit the fibrinolytic response by inhibiting the conversion of plasminogen
to plasmin. Indeed, a small body of evidence shows positive effects of
tranexamic acid on the volume of blood loss.
Study objective
This study has been transitioned to CTIS with ID 2024-513573-49-00 check the CTIS register for the current data.
The objectives of this study are twofold, (1) to investigate whether tranexamic
acid reduces the volume of blood loss and number of allogenic transfusion, and
(2) to investigate the extend of fibrinolysis during burn excisional surgery.
Study design
We will perform a multicenter double blinded randomized clinical trial in
patients scheduled for burn excisional surgery within the Maasstad Hospital in
Rotterdam, Rode Kruis Hospital in Bev-erwijk and Martini Hospital in Groningen.
Intervention
After induction of anesthesia, but before incision, study medication will be
administered. The intervention group will receive 2000mg tranexamic acid. The
placebo group will receive a NaCl 0.9% bolus.
Study burden and risks
Several large studies show that the use of tranexamic acid is safe in a diverse
population. Furterhmore, current guidelines advice the use of tranexamic acid
in case of large blood loss, there-fore the risk associated with participation
is low. The burden on the patient is low as the inter-vention is limited to the
perioperative process and blood sample can be drawn from the intrave-nous
excess which part of the standard of care.
Maasstadweg 21
Rotterdam 3079DZ
NL
Maasstadweg 21
Rotterdam 3079DZ
NL
Listed location countries
Age
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
/ %TBSA, based on retrospective data from Burn Centre Rotterdam), (2) operation
technique used (some techniques show more blood loss than others), (3) time
after burn trauma (i.e. expected healing).
- >=18 years
Exclusion criteria
- Patients with a recorded coagulopathy in their history
- Severe kidney failure (creatinine >500 umol/L)
- Allergy for tranexamic acid
- Acute venous-/arterial thrombosis (ongoing thrombosis). A history of
thrombosis is NOT an exclusion criterion
- Diffuse intravascular coagulation
- Pregnancy
- History of epilepsy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-513573-49-00 |
| EudraCT | EUCTR2020-005405-10-NL |
| CCMO | NL69319.100.20 |