Status:
COMPLETED
Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy
Lead Sponsor:
Medical University of Gdansk
Conditions:
Hemorrhage, Surgical
Bariatric Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Enhanced recovery after bariatric surgery imposes a significant reduction in length of hospital stay. However beneficial for the overall recovery it reduces the hospital observation time. after a lapa...
Detailed Description
Aim: To evaluate if TXA systemic administration reduces postoperative blood loss in bariatric surgeriessleeve gastrectomy operation. Material and methods: A single-blind randomized clinical trial i...
Eligibility Criteria
Inclusion
- Participant were adults qualified for bariatric procedure
Exclusion
- 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.
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06038981
Start Date
July 4 2022
End Date
June 28 2023
Last Update
September 22 2023
Active Locations (1)
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1
Medical University of Gdańsk
Gdansk, Poland