Analyzes of Hemorrhagic Obstetric Patients Whose Were Used Fibrinogen

October 26, 2018 updated by: Ayca Sultan Sahin, Kanuni Sultan Suleyman Training and Research Hospital

Treatment of Obstetric Hemorrhage With Fibrinogen and Blood Products: Retrospective Analyzes

The files of hemorrhagic obstetric patients undergoing surgery and followed in the intensive care unit and using Fibrinogen and blood products were included in the study between January 2015- September 2018 at the Anesthesiology and Reanimation Clinic of SBU Kanuni Sultan Süleyman Training and Research Hospital. Patients under 18 years of age were excluded from the study. In this study, ages, operation types, number of blood and products, the amount of fibrinogen, the results of the hemogram and bleeding parameters, the levels of fibrinogen, the duration of hospital stay and the intensive care unit were recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bleeding is an important event that threatens the patient's life. Too much blood and blood products can be used in massive bleeding. However, unwanted allergic reactions may occur in blood and blood product transfusions. Fibrinogen is the first coagulation factor in coagulopathy. Some studies have shown that when the fibrinogen level falls to <150-200 mg / dl, the bleeding increases dramatically.

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kucukcekmece
      • Istanbul, Kucukcekmece, Turkey, 34306
        • Kanuni Sultan Suleyman Education and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

- Obstetric patients who underwent surgery and followed in ICU and Used Fibrinogen and Blood products in peroperatively or postoperatively

Description

Inclusion Criteria:

  • Obstetric patients, underwent surgery and followed in ICU
  • Used Fibrinogen and Blood products
  • Over 18 years age

Exclusion Criteria:

  • Under 18 years age
  • Obstetric patients, underwent surgery but not used Fibrinogen and Blood products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of fibrinogen (mg/L)
Time Frame: 24 hours
Significant independent predictor for evolution to severe PPH was plasma fibrinogen level.
24 hours
Measurement of hemoglobin (g/dL)
Time Frame: 24 hours
Postpartum hemorrhage (PPH) is a major contributor to maternal death and severe maternal morbidity
24 hours
Amount of fibrinogen consantrates
Time Frame: 24 hours
in order to avoid PPH
24 hours
Amount of blood products (unit)
Time Frame: 24 hours
degree of hemorrhagie
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital stay days
Time Frame: 24 hours
for the recovery time of patients
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Ayca Sultan Sahin, MD, Kanuni Sultan Suleyman Education and Training Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2018

Primary Completion (Actual)

October 16, 2018

Study Completion (Actual)

October 24, 2018

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018.9.19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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