NCT02864875

Brief Summary

This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2015

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

August 9, 2016

Last Update Submit

July 31, 2018

Conditions

TraumaBleeding DisorderFibrinogen; Deficiency, Acquired

Keywords

TraumaCoagulopathyFibrinogenFibrinogen ConcentrateThromboelastometryHypofibrinogenemiaEarly Fibrinogen Replacement

Outcome Measures

Primary Outcomes (1)

  • Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization

    The proportion of patients receiving the allocated treatment up to 60 minutes after randomization

    60 minutes

Secondary Outcomes (17)

  • Overall blood tube drainage

    48 hours

  • Overall blood tube drainage

    Up to four weeks - Through the length of hospital stay

  • Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate

    48 hours

  • Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate

    Up to four days - Through the Length of operating room stay

  • Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate

    Up to four weeks - Through the Length of intensive care unit stay

  • +12 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Not to receive an early replacement of fibrinogen

Intervention

EXPERIMENTAL

Receive early replacement through fibrinogen concentrate (50mg per kg of body weight)

Drug: Fibrinogen concentrate

Interventions

Fibrinogen concentrateDRUG

Receive fibrinogen concentrate 50mg/kg of body weight after randomization

Also known as: Haemocomplettan®
Intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 years
  • Severe trauma patients (Index of Shock Severity \[ISS\] ≥ 15)
  • Hypotension (systolic blood pressure \< 90 mmHg)
  • Tachycardia (heart rate \> 100 bpm)
  • Qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm)

You may not qualify if:

  • Patient or family do not agree to sign the informed consent form
  • Eligible for institutional massive transfusion protocol
  • Pregnant
  • Previous coagulopathy disorders
  • Use of anticoagulants drugs and/or platelet anti aggregation drugs (exception for aspirin)
  • Previous thromboembolic disorders or events
  • Cardiopulmonary arrest before hospital admission
  • Patient admitted after another hospital transfer
  • Time from trauma to screening above six hours
  • Patients with exclusively traumatic brain injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas - FMUSP

São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • Lucena LS, Rodrigues RDR, Carmona MJC, Noronha FJD, Oliveira HP, Lima NM, Pinheiro RB, Silva WAD, Cavalcanti AB. Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial. Clinics (Sao Paulo). 2021 Nov 8;76:e3168. doi: 10.6061/clinics/2021/e3168. eCollection 2021.

    PMID: 34755760DERIVED

MeSH Terms

Conditions

Wounds and InjuriesHemostatic DisordersAfibrinogenemia

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersCoagulation Protein DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Lucas S Lucena, MD

    Hospital das Clínicas da FMUSP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lucas Lucena

Study Record Dates

First Submitted

August 9, 2016

First Posted

August 12, 2016

Study Start

December 1, 2015

Primary Completion

January 1, 2017

Study Completion

July 1, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)