Coagulation AbnormalitiesNCT00972361
Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children
An observational study of Coagulation Abnormalities, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or ventilation tubes insertion in children. A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for… Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Coagulation Abnormalities
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Apr 2011
- 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 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery. The data will include cause of referral, laboratory analysis performed and results. If the data allows the outcome of the operation and bleeding complications, will also recorded.
Who may be able to join
- All the patients referred to the pediatric hematology unit for evaluation due to coagulation abnormalities before minor surgery
Who cannot join
- No exclusion are applicable
Trial locations and contacts
1 site in 1 country.
Israel1 site
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, 18101
About this study
Official title: Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children - a Necessity or Habitude?
Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or ventilation tubes insertion in children.
A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for further evaluation and recommendations before surgery.
The purpose of this study is to summarize the causes of referrals in a cohort of 200 children and to assess the further laboratory analysis preformed and the results obtained.
Read the detailed description
Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery.
The data will include cause of referral, laboratory analysis performed and results.
If the data allows the outcome of the operation and bleeding complications, will also recorded.
- Conditions
- Coagulation Abnormalities
- Keywords
- Adenoidectomy, Tonsillectomy, Ventilation Tubes, Preoperational screening, Coagulation Profile, Lupus anticoagulant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation AbnormalitiesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Koren Ariel, HaEmek Medical Center, Israel
- Investigators
- Ariel Koren, MD, Principal investigator, Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972361
- Sponsor's protocol ID
- 0134-08-EMC
- Status last verified
- Aug 2011
- First submitted
- 3 Sep 2009
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children - a Necessity or Habitude?
- ClinicalTrials.gov ID
- NCT00972361
- Acronym / sponsor ID
- 0134-08-EMC
- Conditions
- Coagulation Abnormalities
- Keywords
- Adenoidectomy, Tonsillectomy, Ventilation Tubes, Preoperational screening, Coagulation Profile, Lupus anticoagulant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Sep 2009 (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.
Routine analysis of coagulation profile is recommended before adenoidectomy, tonsillectomy or ventilation tubes insertion in children.
A proportion of those children reveal borderline abnormal values of Partial Prothrombin Time (aPTT) or Prothrombin Time (PT) and then they are referred to a consultant hematologist for further evaluation and recommendations before surgery.
The purpose of this study is to summarize the causes of referrals in a cohort of 200 children and to assess the further laboratory analysis preformed and the results obtained.
Detailed description
Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery.
The data will include cause of referral, laboratory analysis performed and results.
If the data allows the outcome of the operation and bleeding complications, will also recorded.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Data from about 200 children that were evaluated for abnormal coagulation tests performed before minor surgery. The data will include cause of referral, laboratory analysis performed and results. If the data allows the outcome of the operation and bleeding complications, will also recorded.
Key inclusion criteria (1 listed)
- All the patients referred to the pediatric hematology unit for evaluation due to coagulation abnormalities before minor surgery
Key exclusion criteria (1 listed)
- No exclusion are applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 26 Aug 2011.
Related trials for Coagulation Abnormalities
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
RecruitingPhase 3
A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A
Hemophilia A
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.
Ariel Koren, MD principal investigator
Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
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 Coagulation Abnormalities, run by HaEmek Medical Center, Israel 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 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 26 Aug 2011. 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?
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.
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 26 Aug 2011.