Role of Tranexamic Acid in Reducing Hemorrhagic Events in Bariatric Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPatel Hospital, Pakistan
About this trial
The goal of this clinical trial is to learn if tranexamic acid (TXA) helps reduce bleeding during bariatric surgery, such as laparoscopic sleeve gastrectomy (LSG) and mini gastric bypass (MGB). It will also look at how safe TXA is for people undergoing these procedures. The main questions it aims to answer are:
Does TXA reduce the amount of blood loss during bariatric surgery? Are there any side effects or complications in patients who receive TXA? Researchers will compare TXA to standard care (no TXA) to see if it is effective in reducing bleeding.
Participants will:
Receive either TXA or no TXA (placebo) before surgery Undergo standard bariatric surgery (LSG or MGB) Have their blood loss, hemoglobin levels, and any complications monitored during and after surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients above 18 years of age AND
Undergoing Laparoscopic Sleeve Gastrectomy and MGB
Morbid obesity
Disqualifiers
Patients on anti-platelets/anti-coagulants
Patients with inherited or acquired bleeding disorders
Patients with any acute medical condition predisposing to bleeding
Hormonal contraceptives
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid
DrugAt the time of incision, 1000mg of the drug would be given intravenous, followed by two postoperative doses of 1000mg eight hours apart.
Normal Saline (Placebo)
Other interventionAt the time of incision, 10ml of the drug would be given intravenous, followed by two postoperative doses of 10ml eight hours apart.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: TransamineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Need for additional intervention intra operative after administration of transamine
Bleeding event intraoperative Use of clips intraoperatively Staple line over sewing A drop in baseline hemoglobin in 24 hours Need for intervention post operative 24 hours (endoscopy or re-operation)
Time frame
From enrollment to 24 hours after surgical procedureSponsors and contacts
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Source ClinicalTrials.gov