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NCT00972361 Clinical Trial

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

Coagulation Abnormalities Clinical Trial

Official title:
Routine Preoperative Hemostatic Laboratory Evaluation Prior to Tonsillectomy or Adenoidectomy in Children - a Necessity or Habitude?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00972361
Other study ID # 0134-08-EMC
Secondary ID
Status Completed
Phase N/A
First received September 3, 2009
Last updated August 25, 2011
Start date January 2009
Est. completion date April 2011

Study information
Verified date August 2011
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical 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 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 12 Months to 18 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Pediatric Hematology Unit and Pediatric Dpt B - HaEmek Medical Center Afula

Sponsors (1)
Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel,