Bariatric Surgery Clinical Trial
Official title:
Assessment of the Impact of Perioperative Administration of Tranexamic Acid on Bleeding After Sleeve Gastrectomy - a Randomized Clinical Trial
NCT number | NCT06038981 |
Other study ID # | TXA_SG |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 4, 2022 |
Est. completion date | June 28, 2023 |
Verified date | September 2023 |
Source | Medical University of Gdansk |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 laparoscopic surgery during which one of the longest resection line in surgery or anastomosis are created. Therefore, discovering possible safe and effective ways of pharmacologically reducing surgical blood loss and reducing the risk of postoperative bleeding would be an invaluable addition to the protocol. The systemic use of tranexamic acid (TXA) has been shown to be effective in many types of surgery, reducing the incidence of post-operative bleeding and thereby reducing the rate of reoperation.
Status | Completed |
Enrollment | 300 |
Est. completion date | June 28, 2023 |
Est. primary completion date | June 28, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 (IfabondÃ’, Peters Surgical), staple-line reinforcement. |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Gdansk | Gdansk |
Lead Sponsor | Collaborator |
---|---|
Medical University of Gdansk |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood loss. | Patients were evaluated on the postoperative day 1 by standard lab tests included in the center's protocol, additionally measuring the volume of drainage and heamoglobin concentration in the drainage sample. | First postoperative day. | |
Secondary | TXA complications. | 1-month follow-up observation involving interviewing, examining and conducting lab tests of the study group was provided to determine the safety profile and possible occurrence of TXA complications. | One month. |
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