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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03064152
Other study ID # 2016P001800
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date April 1, 2020

Study information

Verified date May 2021
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The utilization of ROTEM® for transfusion management will identify patients who develop early coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our hypothesis is that earlier identification and directed therapy of such coagulation changes will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma, fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU admission, and shorten length of hospital stay. A cost analysis will be performed.


Description:

Postpartum hemorrhage is increasing in incidence in the United States, renewing interest in targeted approaches to transfusion during cesarean delivery. ROTEM-based transfusion for PPH has been advocated as a mechanism to lower overall requirement of blood components transfused and lower the incidence of transfusion-associated pulmonary morbidity in a small study of women undergoing cesarean delivery. However, larger-scale randomized evaluation of this transfusion approach is warranted for women who experience hemorrhage after vaginal or cesarean delivery. A lower serum fibrinogen level (< 200 mg/dL) at the onset of PPH has a positive predictive value of 100% for progression to severe PPH. However, serum fibrinogen testing has a turnaround time of one hour and is therefore not useful for acute management of PPH. ROTEM provides point-of-care results that have been validated as surrogate markers for serum fibrinogen, within 10 minutes. However, whether ROTEM data alters empiric management of acute PPH is unknown. A comparison of transfusion management decisions and costs incurred for transfused products and transfusion-related morbidity (duration of hospitalization, intensive care unit, respiratory complications) will be performed.


Recruitment information / eligibility

Status Terminated
Enrollment 49
Est. completion date April 1, 2020
Est. primary completion date February 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) II or III health status (minimal to no systemic disease), age between 18 and 50 yrs, singleton pregnancies admitted for labor and delivery anticipated or actual PPH, or anticipated transfusion of blood products. This will be defined by one or more of the following eligibility criteria: 1. Cesarean delivery with moderate or high risk for PPH (see below). 2. Cesarean delivery with acute PPH of > 1000 mL and blood products ordered from the blood bank. 3. Vaginal delivery with acute PPH of > 500 mL and blood products ordered from the blood bank. For criterion #1, moderate risk for PPH is defined by one or more of the following features: - prior cesarean delivery in labor - prior cesarean delivery with known adhesive disease of the placenta - multiple gestation - >4 previous vaginal births - chorioamnionitis with maternal temperature > 101 degrees Fahrenheit - history of previous PPH - large uterine fibroids (> 5 cm) - second stage of labor (10cm cervical dilation to delivery) > 3 hours High risk for postpartum hemorrhage is defined by one or more of the following features: - suspected placenta accreta by pre-delivery ultrasound findings - placenta previa (current or resolved within 4 weeks of delivery) or low-lying placenta - active bleeding on admission prior to delivery Exclusion Criteria: - known coagulation defect prior to delivery including inherited (hemophilia A, von Willebrand disease, thrombocytopenia, other) or iatrogenic causes (anticoagulation therapy), refusal to accept blood transfusion (Jehovah's Witness, other).

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Rotational Thromboelastometry
ROTEM is a point-of-care coagulation assay.

Locations

Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Blood Products Transfused Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
Secondary Blood Loss Visual estimate in suction canister and sponges, or quantitative blood loss From the onset of PPH through 4 hours from leaving the operating room or within 4 hours from the last blood transfusion, whichever occurs later and on average 5 hours.
Secondary Number of Participants With Admission to the Intensive Care Unit Need for admission to the intensive care unit after delivery within 2 weeks of delivery
Secondary Number of Participants Who Required a Hysterectomy Hysterectomy to control postpartum hemorrhage. within 2 weeks of delivery
Secondary Number of Participants Who Experienced Maternal Mortality Maternal death after delivery. within 2 weeks of delivery
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