NCT05464394

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,524

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2022

Typical duration for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

July 12, 2022

Last Update Submit

July 15, 2022

Conditions

HemorrhageBleeding

Keywords

Gastric bypassTranexamic acid

Outcome Measures

Primary Outcomes (1)

  • re-intervention rate

    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

    30 days

Secondary Outcomes (11)

  • the use of haemostatic staple devices

    peroperatively

  • the use of fibrin sealant

    peroperatively

  • blood loss

    peroperatively

  • haemoglobin decrease

    1 day

  • heart rate increase

    1 day

  • +6 more secondary outcomes

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

1500mg Tranexamic acid

Drug: Tranexamic Acid Injection [Cyklokapron]

Placebo

PLACEBO COMPARATOR

sodium chloride

Drug: Sodium chloride 0.9%

Interventions

Tranexamic Acid Injection [Cyklokapron]DRUG

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.

Tranexamic acid
Sodium chloride 0.9%DRUG

100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes

Also known as: Placebo
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 't Hart JWH, Noordman BJ, Palsgraaf-Huisbrink J, Dunkelgrun M, Zengerink HF, Birnie E, van Det MJ, Boerma EG, de Castro SMM, Hazebroek EJ, Langenhoff BS, Verhoef C, Apers JA. Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial). BMJ Open. 2024 May 6;14(5):e078853. doi: 10.1136/bmjopen-2023-078853.

    PMID: 38719323DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Judith WH Hart, MD

CONTACT

010 - 461 6163j.hart@franciscus.nl

Jan A Apers, MD

CONTACT

010 - 461 6163j.apers@franciscus.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2022

First Posted

July 19, 2022

Study Start

September 1, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

July 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Data Statement: The identified individual clinical trial participant-level data, protocols, and the statistical analysis plan will be available upon reasonable request at publication. These data will be available for researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be directed to j.apers@franciscus.nl, and to obtain access, data requestors will need a data access agreement.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Participant-level data, protocols, and the statistical analysis plan will be available upon reasonable request at publication. Within 1 year after the last follow-up.
Access Criteria
upon reasonable request