NCT03723200

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2018

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

7 days

First QC Date

October 24, 2018

Last Update Submit

October 26, 2018

Conditions

Keywords

HemorrhagicObstetricFibrinogen

Outcome Measures

Primary Outcomes (4)

  • Measurement of fibrinogen (mg/L)

    Significant independent predictor for evolution to severe PPH was plasma fibrinogen level.

    24 hours

  • Measurement of hemoglobin (g/dL)

    Postpartum hemorrhage (PPH) is a major contributor to maternal death and severe maternal morbidity

    24 hours

  • Amount of fibrinogen consantrates

    in order to avoid PPH

    24 hours

  • Amount of blood products (unit)

    degree of hemorrhagie

    24 hours

Secondary Outcomes (1)

  • Hospital stay days

    24 hours

Interventions

Fibrinogen and blood products

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsobstetric patients
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Suleyman Education and Training Hospital

Istanbul, Kucukcekmece, 34306, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological Factors

Study Officials

  • Ayca Sultan Sahin, MD

    Kanuni Sultan Suleyman Education and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2018

First Posted

October 29, 2018

Study Start

October 9, 2018

Primary Completion

October 16, 2018

Study Completion

October 24, 2018

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations