This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data. This trial aims to investigate whether peroperative administration of TXA reduces haemorrhage rates in patients who undergo metabolic…
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 measure is postoperative reintervention (administration of
packed red blood cells or, surgical-, radiological-, or endoscopic
intervention).
Secondary outcome
Secondary outcome measures are the use of haemostatic staple devices and fibrin
sealant preoperatively, postoperatively decrease in haemoglobin, increase in
heart rate, rates of suspicions of postoperative haemorrhage (i.e. haemorrhage
for which extra haemoglobin monitoring and administration of TXA) and rates of
VTE, other complications, hospitalization time.
Background summary
Morbid obesity is rising, leading to an increase in metabolic surgery. Over the
years postoperative venous thromboembolic events (VTE) seems to decrease,
whereas the incidence of per- and postoperative haemorrhage seems to increase.
Peroperative administration of tranexamic acid (TXA) may decrease the incidence
of haemorrhage per- and postoperative in patients receiving metabolic surgery.
Study objective
This study has been transitioned to CTIS with ID 2024-513570-22-00 check the CTIS register for the current data.
This trial aims to investigate whether peroperative administration of TXA
reduces haemorrhage rates in patients who undergo metabolic surgery.
Study design
This is a double-blind, multi-centre randomised controlled trial.
Intervention
Patients are randomised between 2 groups: 1) Single dose of 1500 mg TXA, and 2)
Placebo infusion, both to be administered during induction of the procedure by
anaesthesiologist.
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. TXA
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
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: Primary metabolic procedure; >=18 years; good command
of the Dutch or English language.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study: 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)) 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 such as the liver or the spleen.
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 |
|---|---|
| EU-CTR | CTIS2024-513570-22-00 |
| EudraCT | EUCTR2022-001384-27-NL |
| ClinicalTrials.gov | NCT05464394 |
| CCMO | NL81223.100.22 |