DIC SyndromeDICNCT03266432
Thromboelastometry Guided DIC Prevention After Cesarean Section in Pregnant Women With Placenta Previa
A study testing blood samples in people with DIC Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluation of the use of thromboelastometry for early identification of the underlying coagulopathy and to guide individualized transfusion therapy to prevent DIC development during ICU stay after cesarean section in women with placenta previa who require a massive blood transfusion. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- DIC Syndrome
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Aug 2017to 30 Jun 2020
- Phase
- Interventional
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I or II
- Age: ≥ 18 years
- Patients with all types of placenta previa
- Eligible for general anesthesia
- Elective cesarean section
- Singleton term pregnancy
- Normal coagulation profile: prothrombin time (PT), activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level
Who cannot join
- Parturient refusal
- Known coagulopathy
- Women with a history of cardiac, respiratory, renal, neurologic or endocrine diseases.
- Eclampsia and preeclampsia
- Emergency surgeries
- Foetal abnormalities
- Drug induced thrombocytopenia as antibiotics
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospitals
Asyut, 71515
Alaa Mohamed Ahmed Attia, MD, 01099923117, alaa.atya@med.au.edu.eg
Nawal Abdel-aziz Jadel-Rab Abdullah, MD
About this study
Official title: Thromboelastometry Guided Disseminated Intravascular Coagulation Prevention After Cesarean Section in Pregnant Women With Placenta Previa
Evaluation of the use of thromboelastometry for early identification of the underlying coagulopathy and to guide individualized transfusion therapy to prevent DIC development during ICU stay after cesarean section in women with placenta previa who require a massive blood transfusion.
Read the detailed description
Placenta previa is defined as complete or partial implantation of the placenta in the lower segment of the uterus, Patients present with bleeding per vagina occurring usually in the second and third trimester. Bleeding in placenta previa is associated with maternal morbidity and mortality. Transfusion therapy is integral in the acute management of major obstetric hemorrhage. The most important pregnancy related condition leading to bleeding with high mortality and morbidity rates is DIC. Patients exhibit a tendency for severe bleeding associated with the consumption of platelets and coagulation factors. Massive blood transfusions are listed as the main maternal morbidity indicators6.Therefore, early detection of these predictors of DIC and timely intervention of this life-threatening condition is very important. DIC is a clinical-laboratory diagnosis, and laboratory changes need to be interpreted with knowledge of the patient's underlying disorder. Several laboratory parameters are analyzed together as part of a diagnostic algorithm that includes: Prothrombin time (PT), Activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level, and a marker of fibrin degradation, e.g., D-dimer or the soluble fibrin monomer (SFM) 8. None of these markers are taken in isolation, and a combination of results at different time points is particularly helpful in determining the presence of DIC, owing to the multifaceted nature of DIC9, These reasons highlight a strong need for the development of a point-of-care testing system to accurately and reliably diagnose DIC. Thromboelastography (TEM) provides an extended reflection of clot initiation, propagation, and lysis in whole blood. TEM uses three tests: FIBTEM to reveal impaired fibrinogen function, INTEM to reveal coagulation factor deficiency and EXTEM to reveal extrinsic pathway defects
- Conditions
- DIC Syndrome
- Being tested
- blood samples
- Medical subject headings
- Disseminated Intravascular Coagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
three blood samples : first one pre intervention and the other two blood samples post-intervention
| Study group | Role | What they receive |
|---|---|---|
| 60 pregnant women | Other | 60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of Postoperative development of DIC
prevention according to the results of thromboelastometry
Measured: from time of operation till 48 hours postopertive
Secondary outcomes (4)
prevention of Complications of massive transfusion
hypo or hyperkalaemia, hypoc alcaemia, hypothermia and metabolic alkalosis and Length of ICU and hospital stay and In-hospital mortality
Measured: from time of operation till 48 hours postoperative
Systolic blood pressure
systolic blood pressure is measured every hour from time of operation till 48 hours postoperative
Measured: from time of operation till 48 hours postoperative
diastolic blood pressure
diastolic blood pressure is measured every hour from time of operation till 48 hours postoperative
Measured: from time of operation till 48 hours postoperative
heart rate
heart rate is recorded every hour from time of operation till 48 hours
Measured: from time of operation till 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start28 Aug 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DIC SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kilany, Assiut University
- Investigators
- ragaa Ahmed Herdan, MD, Principal investigator, Assiut university hopitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266432
- Sponsor's protocol ID
- thromboelastometryDIC
- Acronym
- DIC
- Status last verified
- Jul 2019
- First submitted
- 28 Aug 2017
- Last updated
- 10 Jul 2019
- Results posted
- 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 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastometry Guided Disseminated Intravascular Coagulation Prevention After Cesarean Section in Pregnant Women With Placenta Previa
- ClinicalTrials.gov ID
- NCT03266432
- Acronym / sponsor ID
- DIC / thromboelastometryDIC
- Conditions
- DIC Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 30 Aug 2017 (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.
Evaluation of the use of thromboelastometry for early identification of the underlying coagulopathy and to guide individualized transfusion therapy to prevent DIC development during ICU stay after cesarean section in women with placenta previa who require a massive blood transfusion.
Detailed description
Placenta previa is defined as complete or partial implantation of the placenta in the lower segment of the uterus, Patients present with bleeding per vagina occurring usually in the second and third trimester. Bleeding in placenta previa is associated with maternal morbidity and mortality. Transfusion therapy is integral in the acute management of major obstetric hemorrhage. The most important pregnancy related condition leading to bleeding with high mortality and morbidity rates is DIC. Patients exhibit a tendency for severe bleeding associated with the consumption of platelets and coagulation factors. Massive blood transfusions are listed as the main maternal morbidity indicators6.Therefore, early detection of these predictors of DIC and timely intervention of this life-threatening condition is very important. DIC is a clinical-laboratory diagnosis, and laboratory changes need to be interpreted with knowledge of the patient's underlying disorder. Several laboratory parameters are analyzed together as part of a diagnostic algorithm that includes: Prothrombin time (PT), Activated partial thromboplastin time (aPTT), the platelet count, fibrinogen level, and a marker of fibrin degradation, e.g., D-dimer or the soluble fibrin monomer (SFM) 8. None of these markers are taken in isolation, and a combination of results at different time points is particularly helpful in determining the presence of DIC, owing to the multifaceted nature of DIC9, These reasons highlight a strong need for the development of a point-of-care testing system to accurately and reliably diagnose DIC. Thromboelastography (TEM) provides an extended reflection of clot initiation, propagation, and lysis in whole blood. TEM uses three tests: FIBTEM to reveal impaired fibrinogen function, INTEM to reveal coagulation factor deficiency and EXTEM to reveal extrinsic pathway defects
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 60 pregnant women | Other | Other: blood samples60 pregnant women diagnosed with placenta previa will take from them 3 blood samples : one pre intervention and two samples postintervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- ASA physical status I or II
- Age: ≥ 18 years
- Patients with all types of placenta previa
- Eligible for general anesthesia
- Elective cesarean section
Key exclusion criteria (7 listed)
- Parturient refusal
- Known coagulopathy
- Women with a history of cardiac, respiratory, renal, neurologic or endocrine diseases.
- Eclampsia and preeclampsia
- Emergency surgeries
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 |
|---|---|---|
| blood samplesthree blood samples : first one pre intervention and the other two blood samples post-intervention | Other | 60 pregnant women |
Primary outcome
prevention of Postoperative development of DIC
Time frame: from time of operation till 48 hours postopertive
prevention according to the results of thromboelastometry
4 secondary outcomes
prevention of Complications of massive transfusion
Time frame: from time of operation till 48 hours postoperative
Systolic blood pressure
Time frame: from time of operation till 48 hours postoperative
diastolic blood pressure
Time frame: from time of operation till 48 hours postoperative
heart rate
Time frame: from time of operation till 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- 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.
ragaa Ahmed Herdan, MD principal investigator
Assiut university hopitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with DIC Syndrome, run by Assiut University at 1 site in Egypt.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Jul 2019. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed kilany, Master (00201090030029, mohamedkelany@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of Postoperative development of DIC (time frame: from time of operation till 48 hours postopertive). 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 10 Jul 2019.