Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
10/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Grounds

ORCID ID

Contact details

Adult Intensive Care Unit
St James Wing
St George's Hospital
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236106542

Study information

Scientific title

Acronym

Study hypothesis

This study will evaluate the possible effect of recombinant factor VIIa (rFVIIa) in the treatment of severe bleeding in severely injured trauma patients undergoing major orthopaedic reconstructive surgery.

Ethics approval

Not provided at time of registration

Study design

Single centre randomised double-blind parallel group placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Acetabular reconstruction

Intervention

Use of recombinant factor VIIa in pelvic fracture and acetabular reconstruction

Intervention type

Drug

Phase

Not Applicable

Drug names

Recombinant factor VIIa (rFVIIa)

Primary outcome measures

Total volume of perioperative blood loss

Secondary outcome measures

1. perioperative transfusion requirement (total volume of allogeneic blood components and salvaged RBC, total number of units of allogeneic blood components)
2. number of patients transfused with allogeneic blood components
3. total volume of crystalloid (Hartmann's solution, dextrose saline, normal saline) and colloid (succinylated gelatin) fluids infused
4. total operating time
5. time taken after entry to intensive care unit (ICU) or recovery unit to reach normal body temperature (36.3–37.1°C) and acid–base status (blood pH 7.35–7.45 with standard base excess –2 to +2)
6. time spent in ICU after surgery
7. days of hospitalization
8. number of times a patient was returned to the operating theatre

Overall trial start date

01/06/2002

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18–60 yr old
2. major pelvic–acetabular fracture caused by trauma
3. scheduled for semi-elective ‘large’ reconstruction surgery with the potential of blood loss exceeding 50% of circulating blood volume

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. history of thrombosis (deep vein thrombosis, pulmonary embolism, cerebral thrombosis)
2. severe head injuries or an abnormal CT scan of the head due to head injuries
3. base deficit of greater than 15 mEq litre–1 or severe acidosis (pH<7.0.) before surgery
4. body weight exceeding 135 kg
5. known or suspected allergy to any drug that may be administered during the course of the study
6. cardiac arrest after trauma and before surgery at St George's Hospital
7. known congenital bleeding disorders
8. known pregnancy or positive pregnancy test at enrolment
9. previous participation in this study
10. previous receipt of rFVIIa within 48 h of screening
11. currently participating or having participated in another investigational drug study within the last 30 days

Recruitment start date

01/06/2002

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Adult Intensive Care Unit
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

St George's Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15734783

Publication citations

  1. Results

    Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM, Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-controlled trial., Br J Anaesth, 2005, 94, 5, 586-591, doi: 10.1093/bja/aei102.

Additional files

Editorial Notes