Trial · NCT01359878
Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial
NCT01359878, Phase 2, Phase 3, Completed, Copenhagen University Hospital at Herlev
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial. Trials, record NCT01359878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01359878
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial
- NCT number
- NCT01359878
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 249 participants, actual
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Conditions
- Postpartum Haemorrhage
- Interventions
- Fibrinogen Concentrate, Isotonic Saline
- First posted
- 2011-05-25
- Last updated
- 2013-09-20
- Other registries' IDs
- eudract:2009-017736-41
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidense of transfusion with allogenic blood products | During hospital stay or until 6 weeks postintervention | |
| Secondary | Severe Postpartum Haemorrhage (PPH) | During hospital stay or until 6 weeks postintervention | Development of "Severe PPH" defined as: "Decrease of haemoglobin (Hb) of \> 2,5 mmol/L, transfusion of at least 4 Red Blood Cell (RBC) units, haemostatic intervention (angiographic embolization, surgical arterial ligation or hysterectomy) or death. |
| Secondary | Estimated blood loss | During hospital stay During hospital stay or until 6 weeks postintervention | |
| Secondary | Total amount of blood transfused | During hospital stay During hospital stay or until 6 weeks postintervention | |
| Secondary | The development of re-bleeding | Untill follow-up 6 weeks postintervention | Defined as bleeding reoccuring after primary haemostasis, and requiring surgical procedures or intervention |
| Secondary | Hemoglobin level below 3,6 mmol/L | During hospital stay or until 6 weeks postintervention | |
| Secondary | Side-effects including thromboembolic complications | Untill 6 weeks postintervention | Safety measures/ Potential known side effects such as: Fever, headache, nausea, vomiting, allergic reactions, anaphylaxis and thrombo-embolic complications (deep venous thrombosis, acute myocardial infarct and lung embolus. All suspected unexpected serious adverse reactions will also be reported in accordance with the Good Clinical Practice (GCP) and the Danish Medicines Agency guidelines. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01359878
GET https://conductscience.org/api/trials/v1/NCT01359878/registered