HemorrhageNCT03723200
Analyzes of Hemorrhagic Obstetric Patients Whose Were Used Fibrinogen
An observational study of Hemorrhage, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Hemorrhage
- What is being tested?
- Fibrinogen and blood products
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2018to 24 Oct 2018
- 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 18 to 50 years
- Women only
- Adult
Study population: - Obstetric patients who underwent surgery and followed in ICU and Used Fibrinogen and Blood products in peroperatively or postoperatively
Who may be able to join
- Obstetric patients, underwent surgery and followed in ICU
- Used Fibrinogen and Blood products
- Over 18 years age
Who cannot join
- Under 18 years age
- Obstetric patients, underwent surgery but not used Fibrinogen and Blood products
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Education and Training Hospital
Istanbul, Kucukcekmece, 34306
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemorrhage
- Being tested
- Fibrinogen and blood products
- Keywords
- Hemorrhagic, Obstetric, Fibrinogen
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen and blood productsOther
Fibrinogen and blood products
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of fibrinogen (mg/L)
Significant independent predictor for evolution to severe PPH was plasma fibrinogen level.
Measured: 24 hours
Measurement of hemoglobin (g/dL)
Postpartum hemorrhage (PPH) is a major contributor to maternal death and severe maternal morbidity
Measured: 24 hours
Amount of fibrinogen consantrates
in order to avoid PPH
Measured: 24 hours
Amount of blood products (unit)
degree of hemorrhagie
Measured: 24 hours
Secondary outcomes (1)
Hospital stay days
for the recovery time of patients
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start9 Oct 2018
- Primary completion16 Oct 2018
- Study completion24 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Sultan Sahin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Ayca Sultan Sahin, MD, Principal investigator, Kanuni Sultan Suleyman Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723200
- Sponsor's protocol ID
- 2018.9.19
- Status last verified
- Oct 2018
- First submitted
- 24 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obstetric Hemorrhage With Fibrinogen and Blood Products: Retrospective Analyzes
- ClinicalTrials.gov ID
- NCT03723200
- Acronym / sponsor ID
- 2018.9.19
- Conditions
- Hemorrhage
- Keywords
- Hemorrhagic, Obstetric, Fibrinogen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 16 Oct 2018 (actual)
- Study completion
- 24 Oct 2018 (actual)
- First posted
- 29 Oct 2018 (actual)
- 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- - Obstetric patients who underwent surgery and followed in ICU and Used Fibrinogen and Blood products in peroperatively or postoperatively
Key inclusion criteria (3 listed)
- Obstetric patients, underwent surgery and followed in ICU
- Used Fibrinogen and Blood products
- Over 18 years age
Key exclusion criteria (2 listed)
- Under 18 years age
- Obstetric patients, underwent surgery but not used Fibrinogen and Blood products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrinogen and blood productsFibrinogen and blood products | Other | – |
Primary outcome
Measurement of fibrinogen (mg/L)
Time frame: 24 hours
Significant independent predictor for evolution to severe PPH was plasma fibrinogen level.
Measurement of hemoglobin (g/dL)
Time frame: 24 hours
Postpartum hemorrhage (PPH) is a major contributor to maternal death and severe maternal morbidity
Amount of fibrinogen consantrates
Time frame: 24 hours
in order to avoid PPH
Amount of blood products (unit)
Time frame: 24 hours
degree of hemorrhagie
1 secondary outcome
Hospital stay days
Time frame: 24 hours
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 30 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Ayca Sultan Sahin, MD principal investigator
Kanuni Sultan Suleyman Education and Training Hospital
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 Hemorrhage, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 30 Oct 2018. 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 Turkey (Türkiye). 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.
What does the primary outcome measure?
Measurement of fibrinogen (mg/L) (time frame: 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 30 Oct 2018.