Blood Coagulation Tests ( INR, APTT)Suga_bleedingNCT02939430
Sugammadex Reversal of Neuromuscular Blockade and Postoperative Bleeding
A study testing Sugammadex intravenous and Intravenous neostigmine and atropine in people with Blood Coagulation Tests ( INR, APTT), run by Mansoura University at 2 sites in Egypt.
Trial summary
Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation. benefits of reversal of neuromuscular blockade appears to be of great value in living donor liver transplant recipients. However, Few Clinical reports have investigated the anticoagulant effect of sugammadex. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Blood Coagulation Tests ( INR, APTT)
- What is being tested?
- Sugammadex intravenous and Intravenous neostigmine and atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- Nov 2016to Nov 2017
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all candidates for living donor liver transplantation
Who cannot join
- massive intraoperative bleeding manifestations of early graft dysfunction
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Mansoura university
Al Mansurah, Dkahleya
Alreafey Kandeel, MD, 00201008158591, refa3ey2@yahoo.com
- Recruiting
Gastroenterology center
Al Mansurah, 35516
Amr M Yassen, professor, amryassen@hotmail.com
About this study
Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation. benefits of reversal of neuromuscular blockade appears to be of great value in living donor liver transplant recipients. However, Few Clinical reports have investigated the anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile of living donor liver transplantation will be investigated.
- Conditions
- Blood Coagulation Tests ( INR, APTT)
- Being tested
- Sugammadex intravenous, Intravenous neostigmine and atropine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex intravenousDrug
Intravenous Injection of sugammadex (2 mg/kg) for reversal of rocuronium induced muscle relaxation
Intravenous neostigmine and atropineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Reversal of neuromuscular blockade will be performed using classic drugs (neostigmine 80 mic/kg and atropine 40 mic/kg) Receives: Drug: Intravenous neostigmine and atropine |
| Sugammadex group | Experimental | Reversal of neuromuscular blockade will be performed using Sugammadex 2mg/kg Receives: Drug: Sugammadex intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
activated partial thromboplastin tile in seconds
Measured: 30 min
Secondary outcomes (1)
international normalized ratio in second
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation Tests ( INR, APTT)Studies of the same condition, open and under way.
- More trials run by Mansoura 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939430
- Sponsor's protocol ID
- Refa-suga-bleeding
- Acronym
- Suga_bleeding
- Status last verified
- Feb 2017
- First submitted
- 17 Oct 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sugammadex Reversal of Neuromuscular Blockade and Postoperative Bleeding
- ClinicalTrials.gov ID
- NCT02939430
- Acronym / sponsor ID
- Suga_bleeding / Refa-suga-bleeding
- Conditions
- Blood Coagulation Tests ( INR, APTT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 20 Oct 2016 (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.
Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation. benefits of reversal of neuromuscular blockade appears to be of great value in living donor liver transplant recipients. However, Few Clinical reports have investigated the anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile of living donor liver transplantation will be investigated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Intravenous neostigmine and atropineReversal of neuromuscular blockade will be performed using classic drugs (neostigmine 80 mic/kg and atropine 40 mic/kg) |
| Sugammadex group | Experimental | Drug: Sugammadex intravenousReversal of neuromuscular blockade will be performed using Sugammadex 2mg/kg |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all candidates for living donor liver transplantation
Key exclusion criteria (1 listed)
- massive intraoperative bleeding manifestations of early graft dysfunction
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 |
|---|---|---|
| Sugammadex intravenousIntravenous Injection of sugammadex (2 mg/kg) for reversal of rocuronium induced muscle relaxation | Drug | Sugammadex group |
| Intravenous neostigmine and atropine | Drug | Control |
Primary outcome
activated partial thromboplastin tile in seconds
Time frame: 30 min
1 secondary outcome
international normalized ratio in second
Time frame: 30 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: Yes
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex intravenous and Intravenous neostigmine and atropine in people with Blood Coagulation Tests ( INR, APTT), run by Mansoura University at 2 sites 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: status not confirmed, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
activated partial thromboplastin tile in seconds (time frame: 30 min). 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 7 Feb 2017.