Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607785550678 Date of Registration: 29/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Haemothorax Auto-Transfusion on Coagulation and Haemostasis (HATCH): A Prospective Self-Controlled Interventional Study
Official scientific title The Effect of Haemothorax Auto-Transfusion on Coagulation and Haemostasis (HATCH): A Prospective Self-Controlled Interventional Study
Brief summary describing the background and objectives of the trial Haemothoraces are a common consequence of thoracic trauma. Autotransfusion of pleural blood drained via intercostal catheter has been associated with reduced allogeneic transfusion requirement and is often practised in low- and middle-income countries (LMIC) where there is often no robust or readily available supply of allogeneic blood products. The functional effect of autotransfusion on systemic coagulation in vivo, however, remains poorly characterised. Pleural blood is profoundly incoagulable in isolation but appears hypercoagulable in mixing studies, raising questions about whether autotransfusion may exacerbate or ameliorate trauma-associated coagulopathy. No prospective viscoelastic data exist. This study aims to characterise the effect haemothorax autotransfusion has on thromboelastographic (TEG) parameters in adult trauma patients.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide) HATCH
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 03/08/2026
Actual trial start date 19/08/2026
Anticipated date of last follow up 30/11/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 10
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Haemothorax autotransfusion A single volume of pleural blood to be auto-transfused, depending on amount drained. Estimated infusion time is approximately 10 minutes. In the resuscitation of thoracic trauma, intercostal catheters (ICC) are commonly inserted to manage haemothoraces. It is standard of care in this centre to "auto-transfuse" the drained pleural blood into patients if shocked or felt, in the opinion of the treating clinician, that additional volume resuscitation would be beneficial. 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Adults aged ≥18 years. • Haemothorax requiring drainage via ICC in the TEU. • A requirement for transfusion of blood products in the opinion of the treating clinician. Transfusion decisions in the TEU are made by senior medical staff based on clinical assessment of haemodynamic status, indicators of end-organ perfusion, and degree of ongoing blood loss; there is no formal protocolised trigger. • Known pre-existing coagulopathy. • Known use of anticoagulant or antiplatelet medication within 7 days. • Suspicion of pleural blood contamination – defined as penetrating thoracoabdominal injury with suspected diaphragmatic injury and clinical or radiographic signs of concomitant hollow viscus injury (e.g. peritonism, haematemesis, or subdiaphragmatic free air). • Known malignant mesothelioma. • Enrolment in another interventional study likely to influence coagulation outcomes. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 99 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/08/2026 University of Witwatersrand HREC
Ethics Committee Address
Street address City Postal code Country
3rd Floor, Phillip Tobias Building, Princes of Wales Terrace, Parktown Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Within-subject changes in R time, as measured by TEG viscoelastic assay Before auto-transfusion, and 30 minutes plus or minus 10 minutes following completion of auto-transfusion
Secondary Outcome • Within-subject changes in other TEG parameters (K time, α angle, maximum amplitude [MA], LY30) between T0 and T1. • Within-subject changes in PlateletMapping parameters (MA-ADP, MA-AA, MA-fibrin, percentage inhibition ADP, percentage inhibition AA) between T0 and T1. • Within-subject changes in venous blood gas parameters (haemoglobin, pH, ionised calcium, and lactate) between T0 and T1. Before auto-transfusion, and 30 minutes plus or minus 10 minutes following completion of auto-transfusion
Secondary Outcome In-hospital mortality, the documented incidence of sepsis, disseminated intravascular coagulation (DIC), acute respiratory distress syndrome (ARDS), and acute kidney injury (AKI). At death or hospital discharge.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chris Hani Baragwanath Academic Hospital 26 Chris Hani Road, Diepkloof Johannesburg 1864 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Chris Hani Baragwanath Academic Hospital 26 Chris Hani Road, Diepkloof Johannesburg 1864 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Haemonetics Corporation are providing in kind device support by lending us the TEG6S analyser and providing cartridges for use 19 Lanner Falcon Road, Samrand, Centurion Johannesburg 0187 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nicholas Chapman nicholaschapman.nz@gmail.com +61416593323 54A Kent Street, Richmond
City Postal code Country Position/Affiliation
Melbourne 3121 Australia Trauma Registrar at Chris Hani Baragwanath Academic Hospital
Role Name Email Phone Street address
Scientific Enquiries Devorah Wineberg baratraumaunit@gmail.com +27724584876 26 Chris Hani Road, Diepkloof
City Postal code Country Position/Affiliation
Johannesburg 1864 South Africa Deputy Head of Trauma Unit and Trauma Surgeon at Chris Hani Baragwanath Academic Hospital
Role Name Email Phone Street address
Public Enquiries Nicholas Chapman nicholaschapman.nz@gmail.com +61416593323 54A Kent Street, Richmond
City Postal code Country Position/Affiliation
Melbourne 3121 Australia Trauma Registrar at Chris Hani Baragwanath Academic Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data collected during the trial, together with the study protocol and statistical analysis plan, are available from the principal investigator/s upon reasonable request, subject to institutional approval. Researchers wishing to access the HATCH dataset must apply through the Trauma Directorate (https://www.baragwanathtrauma.com). Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available from 12 months after publication of the primary results paper for a period of 5 years. Access will be granted to researchers who submit a written research proposal, provide institutional ethics approval for their proposed analysis, and sign a data-sharing agreement. Requests will be reviewed by the principal investigators, with re-identification risk assessed given the small sample size.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.baragwanathtrauma.com/research No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 19/08/2026 Delay in ethics approval 19 Aug 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 19/08/2026 Recruitment has begun Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 19/08/2026 Letter provided FALSE, University of Witwatersrand HREC, 3rd Floor, Phillip Tobias Building, Princes of Wales Terrace, Parktown, Johannesburg, 2193, South Africa, 22 Jun 2026, , +27117171234, medical.researchoffice@wits.ac.za, TRUE, University of Witwatersrand HREC, 3rd Floor, Phillip Tobias Building, Princes of Wales Terrace, Parktown, Johannesburg, 2193, South Africa, 22 Jun 2026, 19 Aug 2026, +27117171234, medical.researchoffice@wits.ac.za, 43759_40072_4737.pdf