Non Variceal BleedNCT02689232
TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.
A study testing Fresh Frozen Plasma, Platelets Concentrate and Cryo Precitipitate in people with Non Variceal Bleed, run by Institute of Liver and Biliary Sciences, India at 2 sites in India.
Trial summary
All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Variceal Bleed
- What is being tested?
- Fresh Frozen Plasma, Platelets Concentrate and Cryo Precitipitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesIndia
- Study dates
- 15 Feb 2016to 3 Mar 2018
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18
- All patient with Non Variceal bleed (INR>1.8 and platelets<50000)
- Hist logical or imaging proven liver cirrhosis.
Who cannot join
- Variceal Bleed,
- Pregnancy.,
- Patients on anticoagulation
- Patients who refused to participate in the study
- Post EVL ulcer bleed
Trial locations and contacts
2 sites in 1 country.
India2 sites
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.
All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.
- Conditions
- Non Variceal Bleed
- Being tested
- Fresh Frozen Plasma, Platelets Concentrate, Cryo Precitipitate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresh Frozen PlasmaBiological
Platelets ConcentrateBiological
Cryo PrecitipitateBiological
| Study group | Role | What they receive |
|---|---|---|
| Thromboelastography (TEG) level | Experimental | Not described Receives: Biological: Fresh Frozen Plasma; Biological: Platelets Concentrate; Biological: Cryo Precitipitate |
| Coagulation Profile | Active comparator | Not described Receives: Biological: Fresh Frozen Plasma; Biological: Platelets Concentrate; Biological: Cryo Precitipitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups
Measured: 42 days
Secondary outcomes (4)
Number of patients with bleed in both groups
Measured: 5 days
Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.
Measured: 42 days
Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.
Measured: 42 days
Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start15 Feb 2016
- Primary completion3 Mar 2018
- Study completion3 Mar 2018
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 Non Variceal BleedStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Juned Ahmad, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689232
- Sponsor's protocol ID
- ILBS-Variceal Bleed-001
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2016
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27.
PubMed 31148204
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02689232
- Acronym / sponsor ID
- ILBS-Variceal Bleed-001
- Conditions
- Non Variceal Bleed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Feb 2016 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 3 Mar 2018 (actual)
- First posted
- 23 Feb 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.
All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thromboelastography (TEG) level | Experimental | Biological: Fresh Frozen Plasma, Biological: Platelets Concentrate, Biological: Cryo Precitipitate |
| Coagulation Profile | Active comparator | Biological: Fresh Frozen Plasma, Biological: Platelets Concentrate, Biological: Cryo Precitipitate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18
- All patient with Non Variceal bleed (INR>1.8 and platelets<50000)
- Hist logical or imaging proven liver cirrhosis.
Key exclusion criteria (5 listed)
- Variceal Bleed,
- Pregnancy.,
- Patients on anticoagulation
- Patients who refused to participate in the study
- Post EVL ulcer bleed
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 |
|---|---|---|
| Fresh Frozen Plasma | Biological | Coagulation Profile, Thromboelastography (TEG) level |
| Platelets Concentrate | Biological | Coagulation Profile, Thromboelastography (TEG) level |
| Cryo Precitipitate | Biological | Coagulation Profile, Thromboelastography (TEG) level |
Primary outcome
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups
Time frame: 42 days
4 secondary outcomes
Number of patients with bleed in both groups
Time frame: 5 days
Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.
Time frame: 42 days
Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.
Time frame: 42 days
Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.
Time frame: 42 days
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 28 Nov 2018.
- Derived from this study: PubMed 31148204Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27.
- 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.
Dr Juned Ahmad, MD principal investigator
Institute of Liver and Biliary Sciences, India
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fresh Frozen Plasma, Platelets Concentrate and Cryo Precitipitate in people with Non Variceal Bleed, run by Institute of Liver and Biliary Sciences, India at 2 sites in India.
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 5 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 28 Nov 2018. 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 India. 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?
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?
Amount of FFP (Fresh Frozen Plasma) transfusion in both groups (time frame: 42 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 NCT02689232, 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 28 Nov 2018.