Cirrhosis, LiverNCT04460222
Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial
A study testing Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure and Conventional transfusion methods to guide blood product transfusion pre invasive procedure in people with Cirrhosis, Liver, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophilic state. Traditional coagulation tests [namely International Normalised Ratio (INR) and Platelets count] are known to be unreliable in predicting bleeding risk before invasive… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure and Conventional transfusion methods to guide blood product transfusion pre invasive procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- 16 Nov 2020to 28 Mar 2022
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- •Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR ≥ 1.5- ≤ 2.5 and/or Platelet count 20,000/mm3- 50,000/mm3 and who are listed for the following invasive procedures : Low risk of bleeding
- Central venous cannulation
- Haemodialysis catheter
- Ascitic or Pleural tapping
- Endoscopic variceal ligation (EVL)
- Endoscopic sclerotherapy (EST)
Show all 9Show fewer
- High risk of bleeding 6. TIPPS 7. Endoscopic retrograde cholangiopancreatography (ERCP) with sphicterotomy 8. Percutaneous drain (PCD) Insertion 9. Biopsies other than liver biopsy
- For children less than 18 years with liver cirrhosis and with a platelet count between 40,000-60,000/mm3 and INR between 1.5-2.0 who are listed for
- 1) Liver biopsy
Who cannot join
- Anti platelet or anti coagulant therapy in the previous 7 days
- Patients with clinical evidence of Disseminated intravascular coagulation (DIC) and/or active bleeding
- Hemodialysis in the past 7 days
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophilic state. Traditional coagulation tests [namely International Normalised Ratio (INR) and Platelets count] are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Rotational Thromboelastometry ( ROTEM) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study is to evaluate the efficacy of ROTEM as a guide for blood products transfusion in cirrhotic children undergoing invasive procedures.
Read the detailed description
Children with cirrhosis listed for invasive procedures and with deranged INR or deranged platelet count will be included in the study and will be block randomized into two groups. To prevent bleeding during the procedure, one group will receive prophylactic transfusion of either fresh frozen plasma (FFP),Platelet or Cryoprecipitate based on the values of INR, platelet and fibrinogen.The second group will undergo ROTEM based correction.
Following correction, the procedure will be done in both the groups. Patients randomized in the ROTEM group will undergo repeat ROTEM and INR, Platelet, Fibrinogen testing (depending on the component transfused), post the procedure, to look at the correction achieved. Similarly, patients randomized in the conventional group will undergo repeat INR, Platelet, fibrinogen testing depending on the component transfused.
Patients will be followed for 24 hours indoors for any evidence of bleeding or transfusion reaction.
- Conditions
- Cirrhosis, Liver
- Being tested
- Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure, Conventional transfusion methods to guide blood product transfusion pre invasive procedure
- Keywords
- ROTEM, Transfusion, Pre invasive procedure, Coagulation disorders, Pediatric liver disease
- Medical subject headings
- Liver Cirrhosis, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational Thromboelastometry to guide blood product transfusion pre invasive procedureProcedure or surgery
Rotational Thromboelastometry will be performed pre procedure and blood component will be transfused if
- EXTEM CT more than 80 sec then FFP will be transfused at 15 ml/kg MCF less than 35 mm then Platelet will be transfused at 10 ml/kg
- FIBTEM MCF less than 7 mm then Cryoprecipitate will be transfused at 5 ml/kg
Conventional transfusion methods to guide blood product transfusion pre invasive procedureProcedure or surgery
Transfusion will be given If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg If Fibrinogen < 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg
| Study group | Role | What they receive |
|---|---|---|
| Rotational Thromboelastometry (ROTEM) | Experimental | To prevent bleeding during invasive procedure, cirrhotic children in the ROTEM group will receive prophylactic transfusion based on the following protocol:- EXTEM CT > 80 sec - FFP will be transfused at 15 ml/kg MCF < 35 mm- Platelet will be transfused at 10 ml/kg FIBTEM MCF < 7 mm- Cryoprecipitate will be transfused at 5 ml/kg Receives: Procedure: Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure |
| Conventional Transfusion | Active comparator | To prevent bleeding during the procedure, cirrhotic children in the conventional group will receive prophylactic transfusion if either FFP, Platelet or Cryoprecipitate is deranged based on the following protocol
* If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg
* If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg
* If Fibrinogen < 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg Receives: Procedure: Conventional transfusion methods to guide blood product transfusion pre invasive procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison in the amount of blood products transfused between the groups
To compare the amount of total component transfused (ml/kg) in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
Measured: 24 hours
Secondary outcomes (6)
Comparison in the amount of FFP transfused between the groups
To compare the amount of FFP (ml/kg) transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
Measured: 24 hours
Comparison in the amount of Platelet transfused between the groups
To compare the amount of Platelet transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
Measured: 24 hours
Comparison in the amount of Cryoprecipitate transfused between the groups
To compare the amount of Cryoprecipitate transfused in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
Measured: 24 hours
Post-procedure bleeding
Comparison of the number of patients having bleeding episodes after procedure between the study groups
Measured: 24 hours
Transfusion related side effects
- To compare the rate of transfusion reactions in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
Measured: 5 days
Comparison between blood products costs between groups
To compare the cost of transfusion components incurred in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start16 Nov 2020
- Primary completion28 Mar 2022
- Study completion28 Mar 2022
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 Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460222
- Sponsor's protocol ID
- ILBS-Cirrhosis-26
- Status last verified
- Jun 2021
- First submitted
- 30 Jun 2020
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maria A, Lal BB, Khanna R, Sood V, Mukund A, Bajpai M, Alam S. Rotational thromboelastometry-guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial. Liver Int. 2022 Nov;42(11):2492-2500. doi: 10.1111/liv.15398. Epub 2022 Aug 25.
PubMed 35977053
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Thromboelastometry Guided Blood Component Use in Children With Cirrhosis Undergoing Invasive Procedures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04460222
- Acronym / sponsor ID
- ILBS-Cirrhosis-26
- Conditions
- Cirrhosis, Liver
- Keywords
- ROTEM, Transfusion, Pre invasive procedure, Coagulation disorders, Pediatric liver disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 16 Nov 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 7 Jul 2020 (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.
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophilic state. Traditional coagulation tests [namely International Normalised Ratio (INR) and Platelets count] are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Rotational Thromboelastometry ( ROTEM) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study is to evaluate the efficacy of ROTEM as a guide for blood products transfusion in cirrhotic children undergoing invasive procedures.
Detailed description
Children with cirrhosis listed for invasive procedures and with deranged INR or deranged platelet count will be included in the study and will be block randomized into two groups. To prevent bleeding during the procedure, one group will receive prophylactic transfusion of either fresh frozen plasma (FFP),Platelet or Cryoprecipitate based on the values of INR, platelet and fibrinogen.The second group will undergo ROTEM based correction.
Following correction, the procedure will be done in both the groups. Patients randomized in the ROTEM group will undergo repeat ROTEM and INR, Platelet, Fibrinogen testing (depending on the component transfused), post the procedure, to look at the correction achieved. Similarly, patients randomized in the conventional group will undergo repeat INR, Platelet, fibrinogen testing depending on the component transfused.
Patients will be followed for 24 hours indoors for any evidence of bleeding or transfusion reaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotational Thromboelastometry (ROTEM) | Experimental | Procedure: Rotational Thromboelastometry to guide blood product transfusion pre invasive procedureTo prevent bleeding during invasive procedure, cirrhotic children in the ROTEM group will receive prophylactic transfusion based on the following protocol:- EXTEM CT > 80 sec - FFP will be transfused at 15 ml/kg MCF < 35 mm- Platelet will be transfused at 10 ml/kg FIBTEM MCF < 7 mm- Cryoprecipitate will be transfused at 5 ml/kg |
| Conventional Transfusion | Active comparator | Procedure: Conventional transfusion methods to guide blood product transfusion pre invasive procedureTo prevent bleeding during the procedure, cirrhotic children in the conventional group will receive prophylactic transfusion if either FFP, Platelet or Cryoprecipitate is deranged based on the following protocol * If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg * If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg * If Fibrinogen < 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- •Children less than 18 years of age with histologic or image proven liver cirrhosis of any etiology with INR ≥ 1.5- ≤ 2.5 and/or Platelet count 20,000/mm3- 50,000/mm3 and who are listed for the following invasive procedures : Low risk of bleeding
- Central venous cannulation
- Haemodialysis catheter
- Ascitic or Pleural tapping
- Endoscopic variceal ligation (EVL)
Key exclusion criteria (3 listed)
- Anti platelet or anti coagulant therapy in the previous 7 days
- Patients with clinical evidence of Disseminated intravascular coagulation (DIC) and/or active bleeding
- Hemodialysis in the past 7 days
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 |
|---|---|---|
| Rotational Thromboelastometry to guide blood product transfusion pre invasive procedureRotational Thromboelastometry will be performed pre procedure and blood component will be transfused if * EXTEM CT more than 80 sec then FFP will be transfused at 15 ml/kg MCF less than 35 mm then Platelet will be transfused at 10 ml/kg * FIBTEM MCF less than 7 mm then Cryoprecipitate will be transfused at 5 ml/kg | Procedure or surgery | Rotational Thromboelastometry (ROTEM) |
| Conventional transfusion methods to guide blood product transfusion pre invasive procedureTransfusion will be given If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg If Fibrinogen < 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg | Procedure or surgery | Conventional Transfusion |
Primary outcome
Comparison in the amount of blood products transfused between the groups
Time frame: 24 hours
To compare the amount of total component transfused (ml/kg) in Rotational Thromboelastometry guided therapy versus Conventional therapy for invasive procedures in children with cirrhosis
6 secondary outcomes
Comparison in the amount of FFP transfused between the groups
Time frame: 24 hours
Comparison in the amount of Platelet transfused between the groups
Time frame: 24 hours
Comparison in the amount of Cryoprecipitate transfused between the groups
Time frame: 24 hours
Post-procedure bleeding
Time frame: 24 hours
Transfusion related side effects
Time frame: 5 days
Comparison between blood products costs between groups
Time frame: 24 hours
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 15 Jun 2022.
- Derived from this study: PubMed 35977053Maria A, Lal BB, Khanna R, Sood V, Mukund A, Bajpai M, Alam S. Rotational thromboelastometry-guided blood component use in cirrhotic children undergoing invasive procedures: Randomized controlled trial. Liver Int. 2022 Nov;42(11):2492-2500. doi: 10.1111/liv.15398. Epub 2022 Aug 25.
- Individual participant dataSharing planned: No
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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.
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 study testing Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure and Conventional transfusion methods to guide blood product transfusion pre invasive procedure in people with Cirrhosis, Liver, run by Institute of Liver and Biliary Sciences, India at 1 site 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 9 inclusion and 3 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 15 Jun 2022. 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 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?
Comparison in the amount of blood products transfused between the groups (time frame: 24 hours). 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 NCT04460222, 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 15 Jun 2022.