Blood Coagulation TestsNCT01167660
Non Invasive Measurement of Coagulation in Term and Preterm Neonates
An observational study of Blood Coagulation Tests, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies. Read more about this study
- Who is it for?
- Ages Up to 2 months
- Conditions the study is for
- Blood Coagulation Tests
- What is being tested?
- The Thrombo-Monitor (ThM)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to Dec 2013
- Phase
- Observational
- 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 2 months
- All sexes
- No healthy volunteers
- Child
Study population: Term and preterm babies born in Meir Medical Center
Who may be able to join
- Newborn babies - term and preterm
- Written parental informed consent
Who cannot join
- Congenital anomalies / chromosomal abnormalities
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Ita Litmanovitz Litmanovitz, MD, 09-7471554, litmani@clalit.org.il
Ita Litmanovits, MD
About this study
The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.
Read the detailed description
Coagulation abnormalities among neonates aren't common - but can be life threatening. Testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). Non-invasive testing can help assess and treat term and preterm neonates at risk. Recently, a non-invasive device to assess the blood coagulation status was developed - The Thrombo-Monitor (ThM). The objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the ThM reading to coagulation analysis from blood.
- Conditions
- Blood Coagulation Tests
- Being tested
- The Thrombo-Monitor (ThM)
- Keywords
- Coagulation tests, Neonates, Non invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Thrombo-Monitor (ThM)Device
Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition.
| Study group | Role | What they receive |
|---|---|---|
| Healthy newborn babies | Healthy newborn babies immediately after birth. Receives: Device: The Thrombo-Monitor (ThM) | |
| Sick newborn babies | Sick newborn babies whose medical condition indicates performing coagulation tests. Receives: Device: The Thrombo-Monitor (ThM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the non-invasive ThM device.
Measured: From birth up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Coagulation TestsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ita Litmanovitz, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167660
- Sponsor's protocol ID
- Pag-ThM2
- Status last verified
- Jun 2010
- First submitted
- 5 Jul 2010
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Measurement of Coagulation in Term and Preterm Neonates
- ClinicalTrials.gov ID
- NCT01167660
- Acronym / sponsor ID
- Pag-ThM2
- Conditions
- Blood Coagulation Tests
- Keywords
- Coagulation tests, Neonates, Non invasive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Jul 2010 (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.
The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.
Detailed description
Coagulation abnormalities among neonates aren't common - but can be life threatening. Testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). Non-invasive testing can help assess and treat term and preterm neonates at risk. Recently, a non-invasive device to assess the blood coagulation status was developed - The Thrombo-Monitor (ThM). The objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the ThM reading to coagulation analysis from blood.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy newborn babies | – | Device: The Thrombo-Monitor (ThM)Healthy newborn babies immediately after birth. |
| Sick newborn babies | – | Device: The Thrombo-Monitor (ThM)Sick newborn babies whose medical condition indicates performing coagulation tests. |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term and preterm babies born in Meir Medical Center
Key inclusion criteria (2 listed)
- Newborn babies - term and preterm
- Written parental informed consent
Key exclusion criteria (1 listed)
- Congenital anomalies / chromosomal abnormalities
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 |
|---|---|---|
| The Thrombo-Monitor (ThM)Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition. | Device | Healthy newborn babies, Sick newborn babies |
Primary outcome
Reliability of the non-invasive ThM device.
Time frame: From birth up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
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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.
Ita Litmanovitz, MD principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Coagulation Tests, run by Meir Medical Center at 1 site in Israel.
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 2 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 12 Feb 2013. 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 Israel. 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?
Contact Ita Litmanovitz, MD (+972-9-7471554, litmani@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the non-invasive ThM device. (time frame: From birth up to 1 month). 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 12 Feb 2013.