HemorrhagePhase 3PATRYNCT05464394
Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass
A Phase 3 study testing Tranexamic Acid Injection [Cyklokapron] and Sodium chloride 0.9% in people with Hemorrhage and Bleeding, run by Franciscus Gasthuis.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhage, Bleeding
- What is being tested?
- Tranexamic Acid Injection [Cyklokapron] and Sodium chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,524 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass to Reduce Haemorrhage (PATRY Study): a Randomised Controlled Trial
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.
- Conditions
- Hemorrhage, Bleeding
- Being tested
- Tranexamic Acid Injection [Cyklokapron], Sodium chloride 0.9%
- Keywords
- Gastric bypass, Tranexamic acid
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sodium chloride 0.9%Drug
Also called Placebo
100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | 1500mg Tranexamic acid Receives: Drug: Tranexamic Acid Injection [Cyklokapron] |
| Placebo | Placebo comparator | sodium chloride Receives: Drug: Sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (11)
the use of haemostatic staple devices
measurement (yes/no). Peroperatively, only on active bleeding a heamostatic staple device will be used. If there is no bleeding no haemostatic staple device will be used.
Measured: peroperatively
the use of fibrin sealant
measurement (yes/no). Peroperatively, if the staple line is not actively bleeding but is oozing, fibrin sealant is used. If there is no oozing, fibrin sealant is not used.
Measured: peroperatively
blood loss
blood loss in ml during surgery
Measured: peroperatively
haemoglobin decrease
haemoglobin decrease postoperative
Measured: 1 day
heart rate increase
heart rate increase postoperative
Measured: 1 day
number of suspicion on haemorrhage
number of suspicion on haemorrhage for which extra haemoglobin monitoring
Measured: 30 days
number of suspicion on haemorrhage for which extra haemoglobin monitoring
number of suspicion on haemorrhage for which extra haemoglobin monitoring
Measured: 30 days
VTE
VTE postoperative
Measured: 30 days
complications rates
postoperative complications rates
Measured: 30 days
length of hospital stay
length of hospital stay
Measured: 30 days
duration of primary surgery
duration of primary surgery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464394
- Sponsor's protocol ID
- 2022-031
- Other IDs
- 2022-001384-27
- Acronym
- PATRY
- Status last verified
- Jul 2022
- First submitted
- 12 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
'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.
PubMed 38719323
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peroperative Administration of Tranexamic Acid in Roux-en-Y Gastric Bypass and One-anastomosis Gastric Bypass to Reduce Haemorrhage (PATRY Study): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05464394
- Acronym / sponsor ID
- PATRY / 2022-031
- Conditions
- Hemorrhage, Bleeding
- Keywords
- Gastric bypass, Tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,524 participants (estimated)
- Lead sponsor
- Franciscus GasthuisUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid Injection [Cyklokapron]1500mg Tranexamic acid |
| Placebo | Placebo comparator | Drug: Sodium chloride 0.9%sodium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid Injection [Cyklokapron]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. | Drug | Tranexamic acid |
| Sodium chloride 0.9%Also: Placebo100 ml sodium chloride 0.9% will be administered in a time frame of 15-30 minutes | Drug | Placebo |
Primary outcome
re-intervention rate
Time frame: 30 days
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
11 secondary outcomes
the use of haemostatic staple devices
Time frame: peroperatively
the use of fibrin sealant
Time frame: peroperatively
blood loss
Time frame: peroperatively
haemoglobin decrease
Time frame: 1 day
heart rate increase
Time frame: 1 day
number of suspicion on haemorrhage
Time frame: 30 days
number of suspicion on haemorrhage for which extra haemoglobin monitoring
Time frame: 30 days
VTE
Time frame: 30 days
complications rates
Time frame: 30 days
length of hospital stay
Time frame: 30 days
duration of primary surgery
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 38719323'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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Hemorrhage
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid Injection [Cyklokapron] and Sodium chloride 0.9% in people with Hemorrhage and Bleeding, run by Franciscus Gasthuis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith WH Hart, MD (010 - 461 6163 ext. +31, j.hart@franciscus.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-intervention rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.