Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00972361
First received: September 3, 2009
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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.


Condition
Coagulation Abnormalities

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children - a Necessity or Habitude?

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Estimated Enrollment: 200
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • All the patients referred to the pediatric hematology unit for evaluation due to coagulation abnormalities before minor surgery

Exclusion Criteria:

  • No exclusion are applicable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972361

Locations
Israel
Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: Ariel Koren, MD Pediatric Dpt B and Pediatric Hemaology Unit - Ha'Emek Medical Center - Afula - Israel
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Hematology Unit and Pediatric Dpt B, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00972361     History of Changes
Other Study ID Numbers: 0134-08-EMC
Study First Received: September 3, 2009
Last Updated: August 25, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Adenoidectomy
Tonsillectomy
Ventilation Tubes
Preoperational screening
Coagulation Profile
Lupus anticoagulant

Additional relevant MeSH terms:
Congenital Abnormalities
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014