Bleeding, Hemorrhage
Conditions
Keywords
Gastric bypass, Tranexamic acid
Brief summary
The incidence of bleeding after metabolic surgery seems to increase. The administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery. Objective: This study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.
Interventions
A set dose of 1500 mg will be used, based on the study population with morbid obesity. It will be administered intravenous dissolved in 100 ml sodium chloride 0.9% in a time frame of 15-30 minutes, with a maximum of 100 mg/min.
DRUGSodium chloride 0.9%
100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes
Sponsors
Franciscus Gasthuis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary metabolic procedure; * Gastric bypass: Roux-en-Y gastric bypass or One-anastomoses gastric bypass; * ≥18 years; * Good command of the Dutch or English language.
Exclusion criteria
* Patients unwilling to give informed consent; * Patients with a medical history of bleeding or VTE (defined as, pulmonary embolism (PE) or deep vein thrombosis (DVT)); * Patients who use anticoagulants; * Arterial bleeding or (iatrogenic) bleeding during the procedure coming from surrounding organs or vascular structures such as the liver or the spleen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| re-intervention rate | 30 days | To compare the re-intervention rate due to haemorrhage within 30 days postoperative, after peroperative administration of TXA versus placebo in patients receiving a RYGB or OAGB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of suspicion on haemorrhage for which extra haemoglobin monitoring | 30 days | number of suspicion on haemorrhage for which extra haemoglobin monitoring |
| VTE | 30 days | VTE postoperative |
| complications rates | 30 days | postoperative complications rates |
| length of hospital stay | 30 days | length of hospital stay |
| duration of primary surgery | 1 day | duration of primary surgery |
| number of suspicion on haemorrhage | 30 days | number of suspicion on haemorrhage for which extra haemoglobin monitoring |
| the use of fibrin sealant | peroperatively | measurement (yes/no). Peroperatively, if the staple line is not actively bleeding but is oozing, fibrin sealant is used. If there is no oozing, fibrin sealant is not used. |
| blood loss | peroperatively | blood loss in ml during surgery |
| haemoglobin decrease | 1 day | haemoglobin decrease postoperative |
| heart rate increase | 1 day | heart rate increase postoperative |
| the use of haemostatic staple devices | peroperatively | measurement (yes/no). Peroperatively, only on active bleeding a heamostatic staple device will be used. If there is no bleeding no haemostatic staple device will be used. |
Contacts
Primary ContactJudith WH Hart, MD
Backup ContactJan A Apers, MD
Outcome results
None listed