TerlipressinPhase 2NCT03572088
Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
A Phase 2 study testing Terlipressin and normal saline in people with Terlipressin and Blood Loss, run by Assiut University.
Trial summary
The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Terlipressin, Blood Loss
- What is being tested?
- Terlipressin and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2017
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients older than 18 years of age,
- ASA classification class I and II,
- Patients assigned for Whipple procedure.
Who cannot join
- Preoperative renal failure,
- Severe liver dysfunction (Child-Turcotte-Pugh grade C),
- Hyponatremia (Na+ <132mmol/l),
- Severe valvular heart disease,
- Heart failure,
- Symptomatic coronary heart disease,
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- Bradycardic arrhythmia (heart rate < 60/min),
- Peripheral artery occlusive disease (clinical stadium II-IV),
- Uncontrolled arterial hypertension (Blood pressure >160/100mmHg despite intensive treatment),
- Pregnancy.
About this study
The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure
- Conditions
- Terlipressin, Blood Loss
- Being tested
- Terlipressin, normal saline
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called glypressin
Terlipressin is a synthetic vasopressin analogue with relative specificity for the splanchnic circulation(Terlipressin was started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.)
normal salineDrug
Also called 0.9 Nacl
Patients received 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Terlipresssin | Active comparator | Terlipressin was started at the beginning of surgery, just after exposure of the portal vein and getting a basal portal pressure reading, as an initial bolus dose of 1 mg over 30 minutes (1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours. Receives: Drug: Terlipressin |
| Control | Placebo comparator | patients received the same volume of normal saline for the same duration (50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours) Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
Amount of intraoperative blood loss in ml
Measured: intaoperative periods
Secondary outcomes (4)
Patients needing blood transfusion
Number of patients needing blood transfusion
Measured: intaoperative periods
Red blood cell units transfused
The number of red blood cell units transfused
Measured: intaoperative periods
portal pressure changes
portal pressure changes in mmHg
Measured: intaoperative periods
ICU stay
ICU stay in days
Measured: postoperative periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study startMay 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TerlipressinStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Mohammed Mahdy Sayed, Assiut University
- Investigators
- Assiut University hospital Egypt, Egypt, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572088
- Sponsor's protocol ID
- ABC-223-DE
- Status last verified
- May 2023
- First submitted
- 17 Jun 2018
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
- ClinicalTrials.gov ID
- NCT03572088
- Acronym / sponsor ID
- ABC-223-DE
- Conditions
- Terlipressin, Blood Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 Jun 2018 (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 present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipresssin | Active comparator | Drug: TerlipressinTerlipressin was started at the beginning of surgery, just after exposure of the portal vein and getting a basal portal pressure reading, as an initial bolus dose of 1 mg over 30 minutes (1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours. |
| Control | Placebo comparator | Drug: normal salinepatients received the same volume of normal saline for the same duration (50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients older than 18 years of age,
- ASA classification class I and II,
- Patients assigned for Whipple procedure.
Key exclusion criteria (10 listed)
- Preoperative renal failure,
- Severe liver dysfunction (Child-Turcotte-Pugh grade C),
- Hyponatremia (Na+ <132mmol/l),
- Severe valvular heart disease,
- Heart failure,
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 |
|---|---|---|
| TerlipressinAlso: glypressinTerlipressin is a synthetic vasopressin analogue with relative specificity for the splanchnic circulation(Terlipressin was started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.) | Drug | Terlipresssin |
| normal salineAlso: 0.9 NaclPatients received 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours. | Drug | Control |
Primary outcome
Intraoperative blood loss
Time frame: intaoperative periods
Amount of intraoperative blood loss in ml
4 secondary outcomes
Patients needing blood transfusion
Time frame: intaoperative periods
Red blood cell units transfused
Time frame: intaoperative periods
portal pressure changes
Time frame: intaoperative periods
ICU stay
Time frame: postoperative periods
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
Assiut University hospital Egypt, Egypt study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terlipressin and normal saline in people with Terlipressin and Blood Loss, run by Assiut University.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 22 May 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative blood loss (time frame: intaoperative periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.