This trial aims to investigate if peroperative administration of TA can reduce the peroperative and postoperative hemorrhage rates in laparoscopic sleeve gastrectomy.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
- Appetite and general nutritional disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome measures are peroperative use of hemostatic clips, the decrease
in hemoglobin after the procedure and rates of postoperative hemorrhage (i.e.
hemorrhage needing administration of packed cells or a surgical or radiological
re-intervention).
Secondary outcome
Secondary outcome measures are rates of deep venous thrombosis (DVT) and
pulmonary embolism (PE).
Background summary
Fast-track protocols are frequently used in bariatric surgery and often include
short-term thromboprophylaxis and short length of hospital stay. These
treatment strategies may negatively affect the occurrence and diagnosis of
postoperative hemorrhage. Over the years, the rates of venous thromboembolic
events (VTE) decrease, while there seems to be an increase in the occurrence of
postoperative hemorrhage. Tranexamic acid (TA) is a plasminogen inhibitor which
inhibits fibrinolysis. Peroperative administration of TA may lower the
incidence of postoperative hemorrhage.
Study objective
This trial aims to investigate if peroperative administration of TA can reduce
the peroperative and postoperative hemorrhage rates in laparoscopic sleeve
gastrectomy.
Study design
This is a double-blind, single center randomized controlled trial.
Intervention
Patients are randomized between 2 groups: 1) Standard protocol with
administration of placebo infusion, and 2) Single dose of 1500 mg TA to be
administered during induction of the procedure by anesthesiologist.
Study burden and risks
All patients will be required to undergo one additional blood drawing in the
week prior to the procedure which will be performed at their weighing
appointment, meaning that this will not require an extra hospital visit. TA has
very little side effects. Therefore we conclude that the expected benefits of
the intervention outweigh the minor risks involved.
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
Primary laparoscopic sleeve gastrectomy; 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 and patients who use therapeutic anticoagulants. Patients will
also be excluded in case of peroperative arterial bleeding or (iatrogenic)
bleeding coming from surrounding organs or vascular structures
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 |
|---|---|
| EudraCT | EUCTR2019-001859-40-NL |
| CCMO | NL69832.100.19 |