Hepatectomy, Surgical Blood Loss, TerlipressinPhase 2NCT02588716
Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.
A Phase 2 study testing Terlipressin and normal saline in people with Hepatectomy, Surgical Blood Loss, Terlipressin, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the effects of Terlipressin infusion on blood loss \& transfusion requirements in cirrhotic patients undergoing major liver resections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy, Surgical Blood Loss, Terlipressin
- 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
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2015to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension
Who cannot join
- Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets < 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR < 50ml/min), heart failure, Bradyarrhythmia (heart rate < 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure >160/100mmHg), and Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the effects of Terlipressin infusion on blood loss \& transfusion requirements in cirrhotic patients undergoing major liver resections.
- Being tested
- Terlipressin, normal saline
- Keywords
- Hepatectomy, Surgical Blood Loss, terlipressin
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
Also called glipressin
Terlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively.
normal salineDrug
Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin | Active comparator | Terlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours Receives: Drug: Terlipressin |
| Control | Placebo comparator | same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours. Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
blood loss in ml
Measured: intraoperative period
Secondary outcomes (2)
blood units transfused
number of packed RBCs units transfused
Measured: intraoperative period
lactate level
lactate level in blood gas sample in mmol/L
Measured: at start and end of resection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionDec 2016
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 Hepatectomy, Surgical Blood Loss, 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Samy Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588716
- Sponsor's protocol ID
- Terlipressin
- Status last verified
- Jul 2015
- First submitted
- 26 Oct 2015
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Abbas MS, Mohamed KS, Ibraheim OA, Taha AM, Ibraheem TM, Fadel BA, Elawamy A, Abbas AM. Effects of terlipressin infusion on blood loss and transfusion needs during liver resection: A randomised trial. Acta Anaesthesiol Scand. 2019 Jan;63(1):34-39. doi: 10.1111/aas.13226. Epub 2018 Aug 5.
PubMed 30079635
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.
- ClinicalTrials.gov ID
- NCT02588716
- Acronym / sponsor ID
- Terlipressin
- Keywords
- Hepatectomy, Surgical Blood Loss, terlipressin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Oct 2015 (estimated)
- 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.
To evaluate the effects of Terlipressin infusion on blood loss \& transfusion requirements in cirrhotic patients undergoing major liver resections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipressin | Active comparator | Drug: TerlipressinTerlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours |
| Control | Placebo comparator | Drug: normal salinesame volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension
Key exclusion criteria (1 listed)
- Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets < 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR < 50ml/min), heart failure, Bradyarrhythmia (heart rate < 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure >160/100mmHg), and Pregnancy
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: glipressinTerlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively. | Drug | Terlipressin |
| normal salineSame volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours. | Drug | Control |
Primary outcome
blood loss
Time frame: intraoperative period
blood loss in ml
2 secondary outcomes
blood units transfused
Time frame: intraoperative period
lactate level
Time frame: at start and end of resection
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 27 Dec 2017.
- Derived from this study: PubMed 30079635Abbas MS, Mohamed KS, Ibraheim OA, Taha AM, Ibraheem TM, Fadel BA, Elawamy A, Abbas AM. Effects of terlipressin infusion on blood loss and transfusion needs during liver resection: A randomised trial. Acta Anaesthesiol Scand. 2019 Jan;63(1):34-39. doi: 10.1111/aas.13226. Epub 2018 Aug 5.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terlipressin and normal saline in people with Hepatectomy, Surgical Blood Loss, Terlipressin, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
blood loss (time frame: intraoperative period). 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 NCT02588716, 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 27 Dec 2017.