Peroperative Administration of Tranexamic Acid in Sleeve gastrectomy (PATAS) to reduce hemorrhage rates

Peroperative Administration of Tranexamic Acid in Sleeve gastrectomy (PATAS) to reduce hemorrhage rates - PATAS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47960

Enrollment

100

Registered

2019-07-29

Start date

2020-07-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hemorrhage Sleeve gastrectomy

Interventions

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 anest

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Primary laparoscopic sleeve gastrectomy; good command of the Dutch or English language

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary outcome measures are rates of deep venous thrombosis (DVT) and pulmonary embolism (PE).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)