Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy
Hemorrhage, Surgical, Bariatric Surgery, Tranexamic Acid
About this trial
This is an interventional treatment trial for Hemorrhage, Surgical focused on measuring bariatric surgery, Hemorrhage, Tranexamic Acid
Eligibility Criteria
Inclusion Criteria: Participant were adults qualified for bariatric procedure Exclusion Criteria: Primary (pre-operative) exclusion criteria were as follows: Usage of anticoagulative agents in the perioperative period including: Indirect thrombin inhibitors (Fondaparinux, UFH, LMWH in therapeutic dosing) Direct inhibitors of factor Xa (NOAC) Direct thrombin inhibitors (Dabigatran) Vitamin K Antagonists (VKA: acenokumarol, warfarin) Platelet aggregation inhibitors (excluding ASA in dosing 75mg per day) P2Y12 receptor inhibitors Prior diagnosis of congenital or acquired blood coagulation disorders Diagnosed allergic reactions to TXA in medical history Chronic Kidney Disease in stage G3 or higher Chronic hemodialysis Haematuria in medical history Seizures in medical history To achieve the most homogenous group of patients and to reduce possible bias due to additional interventions occurring during the operation - further, postoperative exclusion criteria were introduced: Performed operation other than laparoscopic sleeve gastrectomy (LSG) Necessity of TXA administration in the postoperative period Additional, supplementary heamostatic materials and methods were used during the operation - deviation from the standard operation protocol such as: use of oxidized regenerative cellulose (ORC), cyanoacrylate laparoscopic bioglue (IfabondÒ, Peters Surgical), staple-line reinforcement.
Sites / Locations
- Medical University of Gdańsk
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control Group (CG).
TXA group.
no tranexamic acid administration.
Administration of 1g tranexamic acid intravenous bolus, after anesthesia was introduced.