Obstetric Labor ComplicationsNCT03523780
Transfusion of Whole Blood and Cesarean Delivery: A Retrospective Review
An observational study of Obstetric Labor Complications, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The rate of postpartum hemorrhage (PPH) has risen dramatically in the developed world, along with a rise in blood transfusion rates. The rate of cesarean delivery has increased dramatically in the past decade and is well over 30% in the United States. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obstetric Labor Complications
- How many people
- 1,500 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2017to 8 Apr 2020
- 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
- No healthy volunteers
- Adult
Study population: This is a retrospective study. Data retrospectively collected from medical record of the subjects underwent cesarean delivery and also received a blood transfusion or blood component therapy in the period between January 1, 2015 through January 1, 2016
Who may be able to join
- Subjects who underwent cesarean delivery
- Received a blood transfusion or blood component therapy
Who cannot join
- If sufficient information from the electronic record cannot be collected, those patients will be excluded.
- Subjects with pre-existing coagulation abnormalities such as hemophilia A, Von Willebrand's disease or any history of hereditary coagulopathies
- The utilization of the Massive Transfusion Protocol (MTP) intraoperatively
- Subjects with pre-existing renal failure, preexisting peripartum cardiomyopathy, or acute lung injury.
- Subjects who has transfusion of blood group O as non O recipient or received emergent uncross-matched blood in hospital admission or wrong blood transfusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Transfusion of Whole Blood Better for Resuscitation in Cesarean Delivery? A Retrospective Analysis of the Transfusion of Whole Blood Versus Component Therapy During Cesarean Delivery.
The rate of postpartum hemorrhage (PPH) has risen dramatically in the developed world, along with a rise in blood transfusion rates. The rate of cesarean delivery has increased dramatically in the past decade and is well over 30% in the United States. With an increase in primary and repeat cesarean delivery, comes the added risk of abnormal placentation, which can contribute to maternal and fetal morbidity and mortality via placenta accreta, increta, and percreta. The incidence of accreta has increased 10-fold over the past 50 years, becoming the most common reason for cesarean hysterectomy in highly industrialized countries. These conditions have tremendous impact on maternal outcomes.
Although whole blood (WB) contains all of the individual blood components, there are concerns for the use of WB due to the potential limitations such as the hemostatic efficacy of platelet after cold storage, the risk of hemolytic transfusion reaction following the transfusion of un-cross matched WB and the logistical issues in providing WB. Traditional obstetric transfusion protocols involve blood component therapy. Whole blood contains all components and could be more efficient for massive transfusion in obstetric hemorrhage. Trauma resuscitation protocols mimic whole blood in the 1:1:1 transfusion protocols of packed red blood cells to plasma to platelet ratio. It is difficult to compare trauma resuscitation to obstetric hemorrhage, but both can involve significant resuscitation and serious sequelae from unnecessary transfusion.
Read more
The use of WB instead of component therapy may reduce the multiple organ dysfunction rates due to the rapid resolution of shock and coagulopathy. Additionally, the number of donor exposure is important factor for the transfusion-related allergic reactions including severe systemic reactions such as anaphylaxis. Use of WB may decrease number of donor exposure. The secondary aim is to compare the incidence of 3 common adverse outcomes associated with the transfusion of blood products in subjects who receive whole blood versus component therapy.
Investigators hypothesize that the patients receiving WB will have fewer incidences of a) acute renal failure, b) acute heart failure and c) transfusion-related lung disease compared to those receiving component therapy.
Read the detailed description
This is a retrospective cohort study. There is no research-related interventions. Data was collected retrospectively via the electronic medical records of the subjects who underwent cesarean delivery, and also received a blood transfusion during the intraoperative and postoperative periods between January 1, 2010 through December 1, 2016. Parkland Hospital Office of Research Administration pulled to data from eligible subjects' medical record based on ICD or CPT codes. Retrospective cohort was grouped as whole blood therapy and component therapy.
The data from the Electronic Medical Record pertaining to maternal characteristics includes demographic information, history of risk factors for PPH, prepartum and postoperative laboratory values, characteristic of cesarean section, type of the anesthesia utilized, Blood group, type and amounts of the blood products given, type of the components, how many overall units are given during the intraoperative period, need for an intraoperative hysterectomy, length of total hospital stay, evidences of hemolytic reaction caused by transfusion, the ICD 10 diagnosis of acute renal failure, acute heart failure due to volume overload, and transfusion-related lung disease (TRALI) on the discharge summary.
- Conditions
- Obstetric Labor Complications
- Medical subject headings
- Obstetric Labor Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute renal failure
Acute renal failure associated with the transfusion of blood products
Measured: During hospital stay approximately 2-3 week time frame
Secondary outcomes (2)
Acute heart failure
Acute heart failure associated with the transfusion of blood products
Measured: During hospital stay approximately 2-week time frame
Transfusion-related lung disease
Transfusion-related lung disease following the transfusion of blood products
Measured: During hospital stay approximately 2-3 week time frame
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start10 Aug 2017
- Primary completion30 Oct 2019
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seema Dave, MPH, Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523780
- Sponsor's protocol ID
- 122016-079
- Status last verified
- May 2020
- First submitted
- 1 May 2018
- Last updated
- 19 May 2020
- 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 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Transfusion of Whole Blood Better for Resuscitation in Cesarean Delivery? A Retrospective Analysis of the Transfusion of Whole Blood Versus Component Therapy During Cesarean Delivery.
- ClinicalTrials.gov ID
- NCT03523780
- Acronym / sponsor ID
- 122016-079
- Conditions
- Obstetric Labor Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 14 May 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 rate of postpartum hemorrhage (PPH) has risen dramatically in the developed world, along with a rise in blood transfusion rates. The rate of cesarean delivery has increased dramatically in the past decade and is well over 30% in the United States. With an increase in primary and repeat cesarean delivery, comes the added risk of abnormal placentation, which can contribute to maternal and fetal morbidity and mortality via placenta accreta, increta, and percreta. The incidence of accreta has increased 10-fold over the past 50 years, becoming the most common reason for cesarean hysterectomy in highly industrialized countries. These conditions have tremendous impact on maternal outcomes.
Although whole blood (WB) contains all of the individual blood components, there are concerns for the use of WB due to the potential limitations such as the hemostatic efficacy of platelet after cold storage, the risk of hemolytic transfusion reaction following the transfusion of un-cross matched WB and the logistical issues in providing WB. Traditional obstetric transfusion protocols involve blood component therapy. Whole blood contains all components and could be more efficient for massive transfusion in obstetric hemorrhage. Trauma resuscitation protocols mimic whole blood in the 1:1:1 transfusion protocols of packed red blood cells to plasma to platelet ratio. It is difficult to compare trauma resuscitation to obstetric hemorrhage, but both can involve significant resuscitation and serious sequelae from unnecessary transfusion.
The use of WB instead of component therapy may reduce the multiple organ dysfunction rates due to the rapid resolution of shock and coagulopathy. Additionally, the number of donor exposure is important factor for the transfusion-related allergic reactions including severe systemic reactions such as anaphylaxis. Use of WB may decrease number of donor exposure. The secondary aim is to compare the incidence of 3 common adverse outcomes associated with the transfusion of blood products in subjects who receive whole blood versus component therapy.
Investigators hypothesize that the patients receiving WB will have fewer incidences of a) acute renal failure, b) acute heart failure and c) transfusion-related lung disease compared to those receiving component therapy.
Detailed description
This is a retrospective cohort study. There is no research-related interventions. Data was collected retrospectively via the electronic medical records of the subjects who underwent cesarean delivery, and also received a blood transfusion during the intraoperative and postoperative periods between January 1, 2010 through December 1, 2016. Parkland Hospital Office of Research Administration pulled to data from eligible subjects' medical record based on ICD or CPT codes. Retrospective cohort was grouped as whole blood therapy and component therapy.
The data from the Electronic Medical Record pertaining to maternal characteristics includes demographic information, history of risk factors for PPH, prepartum and postoperative laboratory values, characteristic of cesarean section, type of the anesthesia utilized, Blood group, type and amounts of the blood products given, type of the components, how many overall units are given during the intraoperative period, need for an intraoperative hysterectomy, length of total hospital stay, evidences of hemolytic reaction caused by transfusion, the ICD 10 diagnosis of acute renal failure, acute heart failure due to volume overload, and transfusion-related lung disease (TRALI) on the discharge summary.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This is a retrospective study. Data retrospectively collected from medical record of the subjects underwent cesarean delivery and also received a blood transfusion or blood component therapy in the period between January 1, 2015 through January 1, 2016
Key inclusion criteria (2 listed)
- Subjects who underwent cesarean delivery
- Received a blood transfusion or blood component therapy
Key exclusion criteria (5 listed)
- If sufficient information from the electronic record cannot be collected, those patients will be excluded.
- Subjects with pre-existing coagulation abnormalities such as hemophilia A, Von Willebrand's disease or any history of hereditary coagulopathies
- The utilization of the Massive Transfusion Protocol (MTP) intraoperatively
- Subjects with pre-existing renal failure, preexisting peripartum cardiomyopathy, or acute lung injury.
- Subjects who has transfusion of blood group O as non O recipient or received emergent uncross-matched blood in hospital admission or wrong blood transfusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute renal failure
Time frame: During hospital stay approximately 2-3 week time frame
Acute renal failure associated with the transfusion of blood products
2 secondary outcomes
Acute heart failure
Time frame: During hospital stay approximately 2-week time frame
Transfusion-related lung disease
Time frame: During hospital stay approximately 2-3 week time frame
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 19 May 2020.
- 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.
Seema Dave, MPH study chair
University of Texas Southwestern Medical Center
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 Obstetric Labor Complications, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 2 inclusion and 5 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 19 May 2020. 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 United States. 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?
Acute renal failure (time frame: During hospital stay approximately 2-3 week time frame). 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 19 May 2020.